Company names starting with "G"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Gamida Cell Ltd.
OMISIRGE (For Injection) (Intravenous) omidubicel-onlv
NDA Applicant: Gamida Cell Ltd. BLA No.: 125738 Prod. No.: 001 Rx (>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol); 002 Rx (>8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 17, 2030	Orphan Designation: Enhancement of cell engraftment and immune reconstitution in patients receiving hematopoietic stem cell transplant Approved Labeled Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection Exclusivity Protected Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection

Patents	Expiration	Patented Use
Pat. No. 7332289 Method of purifying protein Claim Types: Process Pat. Sub. Date(s): None	Aug 4, 2023
Pat. No. 7521052 Methods for treating interleukin-6 related diseases Claim Types: Method of use Pat. Sub. Date(s): None	Apr 28, 2024
Pat. No. 8398980 Subtypes of humanized antibody against interleuken-6 receptor Claim Types: Compound; Composition Pat. Sub. Date(s): None	Sep 27, 2026
Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None	Jan 9, 2030
Pat. No. 8568720 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None	Nov 5, 2029
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 9, 2027
Pat. No. 8580264 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None	Nov 8, 2030
Pat. No. 8617550 Treatment of vasculitis with IL-6 antagonist Claim Types: Method of use Pat. Sub. Date(s): None	Sep 11, 2025
Pat. No. 8709409 Method for treating rheumatoid arthritis by administering an anti-IL-6 antibody and methotrexate Claim Types: Method of use Pat. Sub. Date(s): None	Jun 22, 2024
Pat. No. 8734800 Subtypes of humanized antibody against interleukin-6 receptor Claim Types: Method of use Pat. Sub. Date(s): None	Mar 24, 2025
Pat. No. 9539263 Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis Claim Types: Method of use Pat. Sub. Date(s): None	Nov 8, 2030
Pat. No. 9630988 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None	Jun 13, 2032
Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None	Jan 9, 2030
Pat. No. 9750752 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None	Sep 1, 2031
Pat. No. 9902777 Methods for producing subtypes of humanized antibody against interleukin-6 receptor Claim Types: Process Pat. Sub. Date(s): None	May 28, 2025
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 15, 2033
Pat. No. 10231981 Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None	Nov 19, 2030
Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None	Jul 31, 2035
Pat. No. 10501769 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None	Oct 25, 2030
Pat. No. 10590164 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None	Mar 19, 2032
Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None	May 26, 2030
Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 15, 2033
Pat. No. 10744201 Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate Claim Types: Method of improving a treatment Pat. Sub. Date(s): None	Apr 28, 2024
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 15, 2033
Pat. No. 10874677 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Device Pat. Sub. Date(s): None	Mar 4, 2031
Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None	Aug 11, 2029
Pat. No. 11008394 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None	Dec 26, 2028
Pat. No. 11021728 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation Pat. Sub. Date(s): None	Oct 25, 2030
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 9, 2027
Pat. No. 11136375 Method for production of antibody Claim Types: Process Pat. Sub. Date(s): None	Oct 14, 2028
Pat. No. 11136610 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): None	Oct 25, 2030
Pat. No. 11359026 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None	Dec 26, 2028
Pat. No. 11377678 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None	Oct 25, 2030
Pat. No. 11584798 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None	Dec 26, 2028
Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 29, 2020	Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug Exclusivity	Aug 30, 2024	Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug Exclusivity	Mar 4, 2028	Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

Genentech, Inc.
Actemra (Injection) (Subcutaneous) tocilizumab
NDA Applicant: Genentech, Inc. BLA No.: 125472 Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Apr 29, 2020 Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.

Exclusivity Type: Orphan Drug Exclusivity Aug 30, 2024 Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older

Exclusivity Type: Orphan Drug Exclusivity Mar 4, 2028 Orphan Designation: Treatment of systemic sclerosis
Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 29, 2020	Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug Exclusivity	Aug 30, 2024	Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug Exclusivity	Mar 4, 2028	Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

Patents	Expiration	Patented Use
Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography Claim Types: Process Pat. Sub. Date(s): None	Mar 8, 2025
Pat. No. 8460895 Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium Claim Types: Process Pat. Sub. Date(s): None	Mar 11, 2029
Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None	Jan 4, 2031
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Pat. No. 9441035 Cell culture media and methods of antibody production Claim Types: Process Pat. Sub. Date(s): None	Apr 23, 2034
Pat. No. 9487809 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Process Pat. Sub. Date(s): None	Jan 14, 2032
Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None	Aug 6, 2030
Pat. No. 9795672 Treatment with anti-VEGF antibodies Claim Types: Method of use Pat. Sub. Date(s): None	May 28, 2024
Pat. No. 10011856 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Cell culture Pat. Sub. Date(s): None	May 26, 2031
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 14, 2034
Pat. No. 10208355 Method of treatment for glioblastoma by administering a VEGF antagonist Claim Types: Method of use Pat. Sub. Date(s): None	Jul 14, 2035
Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization Claim Types: Analytical procedure Pat. Sub. Date(s): None	Jul 11, 2035
Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None	Jul 31, 2035
Pat. No. 10513697 CO.sub.2 profile cultivation Claim Types: Process Pat. Sub. Date(s): None	Sep 17, 2032
Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None	May 26, 2031
Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 14, 2034
Pat. No. 10704071 Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Vector Pat. Sub. Date(s): None	Aug 18, 2031
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 14, 2034
Pat. No. 10906934 Protein purification methods Claim Types: Process Pat. Sub. Date(s): None	Oct 12, 2033
Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None	Aug 6, 2030
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 5, 2016	Orphan Designation: Treatment of malignant glioma Approved Labeled Indication: Treatment of glioblastoma with progressive disease following prior therapy
Exclusivity Type: Orphan Drug Exclusivity	Jul 31, 2016	Orphan Designation: Treatment of renal cell carcinoma Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa
Exclusivity Type: Orphan Drug Exclusivity	Nov 14, 2021	Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian cancer who have received no more than 2 prior chemotherapy regimens.
Exclusivity Type: Orphan Drug Exclusivity	Nov 14, 2021	Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
Exclusivity Type: Orphan Drug Exclusivity	Nov 14, 2021	Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than 2 prior chemotherapy regimens. Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent fallopian tube cancer who have received no more than 2 prior chemotherapy regimens.
Exclusivity Type: Orphan Drug Exclusivity	Dec 6, 2023	Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer.
Exclusivity Type: Orphan Drug Exclusivity	Dec 6, 2023	Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent primary peritoneal cancer.
Exclusivity Type: Orphan Drug Exclusivity	Dec 6, 2023	Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent fallopian tube cancer.
Exclusivity Type: Orphan Drug Exclusivity	Jun 13, 2025	Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian cancer following initial surgical resection.
Exclusivity Type: Orphan Drug Exclusivity	Jun 13, 2025	Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV fallopian tube cancer following initial surgical resection.
Exclusivity Type: Orphan Drug Exclusivity	Jun 13, 2025	Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV primary peritoneal cancer following initial surgical resection.
Exclusivity Type: Orphan Drug Exclusivity	May 29, 2027	Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Genentech, Inc.
Enspryng (Injection) (Subcutaneous) satralizumab-mwge
NDA Applicant: Genentech, Inc. BLA No.: 761149 Prod. No.: 001 Rx (120MG/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 14, 2027 Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder
Approved Labeled Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive
Exclusivity Protected Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 14, 2027	Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder Approved Labeled Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive Exclusivity Protected Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive

Genentech, Inc.
Gazyva (Injection) (Intravenous) obinutuzumab
NDA Applicant: Genentech, Inc. BLA No.: 125486 Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 1, 2020 Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Exclusivity Protected Indication: Treatment of patients with previously untreated chronic lymphocytic leukemia in combination with chlorambucil.

Exclusivity Type: Orphan Drug Exclusivity Feb 26, 2023 Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen
Exclusivity Protected Indication: in combination with bendamustine followed by Gazyva monotherapy, indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.

Exclusivity Type: Orphan Drug Exclusivity Nov 16, 2024 Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma
Exclusivity Protected Indication: In combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 1, 2020	Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). Exclusivity Protected Indication: Treatment of patients with previously untreated chronic lymphocytic leukemia in combination with chlorambucil.
Exclusivity Type: Orphan Drug Exclusivity	Feb 26, 2023	Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen Exclusivity Protected Indication: in combination with bendamustine followed by Gazyva monotherapy, indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
Exclusivity Type: Orphan Drug Exclusivity	Nov 16, 2024	Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma Exclusivity Protected Indication: In combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.

Genentech, Inc.
Hemlibra (Injection) (Subcutaneous) emicizumab-kxwh
NDA Applicant: Genentech, Inc. BLA No.: 761083 Prod. No.: 001 Rx (30MG/ML); 002 Rx (60MG/0.4ML); 003 Rx (105MG/0.7ML); 004 Rx (150MG/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 16, 2024 Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Protected Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors

Exclusivity Type: Orphan Drug Exclusivity Oct 4, 2025 Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
Exclusivity Protected Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 16, 2024	Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors Exclusivity Protected Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Type: Orphan Drug Exclusivity	Oct 4, 2025	Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. Exclusivity Protected Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

Genentech, Inc.
Herceptin (For Injection) (Intravenous) trastuzumab
NDA Applicant: Genentech, Inc. BLA No.: 103792 Prod. No.: 002 Rx (150MG) BLA No.: 103792 Prod. No.: 001 Disc (420MG)

Patents Expiration Patented Use

Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None Jul 8, 2028
Pat. No. 10662237 Method to improve virus filtration capacity
Claim Types: Process
Pat. Sub. Date(s): None May 26, 2030
Pat. No. 10808037 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None Jul 8, 2028
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None Jul 8, 2028
Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 20, 2017 Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction
Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease

Patents	Expiration	Patented Use
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None	May 26, 2030
Pat. No. 10808037 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 20, 2017	Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease

Patents	Expiration	Patented Use
Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Nov 1, 2021
Pat. No. 6828121 Bacterial host strains Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None	Jul 8, 2022
Pat. No. 6921659 Protease-deficient cells Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None	Oct 17, 2023
Pat. No. 8383773 Protein product and method for reducing biomass-biomass interactions Claim Types: Product-by-process Pat. Sub. Date(s): None	Dec 13, 2023
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None	Jul 8, 2028
Pat. No. 9688775 System for antibody expression and assembly Claim Types: Process Pat. Sub. Date(s): None	Dec 31, 2022
Pat. No. 9765379 Harvest operations for recombinant proteins Claim Types: Process Pat. Sub. Date(s): None	Mar 10, 2034
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 14, 2034
Pat. No. 10112994 Methods of producing two chain proteins in bacteria Claim Types: Process Pat. Sub. Date(s): None	Nov 5, 2035
Pat. No. 10421984 Methods for reducing norleucine misincorporation into proteins using a microorganism comprising a mutant metA allele Claim Types: Process Pat. Sub. Date(s): None	Sep 19, 2033
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None	Mar 14, 2034

Genentech, Inc.
Lunsumio (Injection) (Intravenous) mosunetuzumab-axgb
NDA Applicant: Genentech, Inc. BLA No.: 761263 Prod. No.: 001 Rx (1MG/ML); 002 Rx (30MG/30ML (1MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 22, 2029 Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 22, 2029	Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Genentech, Inc.
Nutropin (For Injection) (Subcutaneous) somatropin
NDA Applicant: Genentech, Inc. BLA No.: 020168 Prod. No.: 001 Disc (5MG); 002 Disc (10MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 17, 1992 Orphan Designation: For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Exclusivity Type: Orphan Drug Exclusivity Nov 17, 2000 Orphan Designation: Treatment of growth retardation associated with chronic renal failure.
Approved Labeled Indication: Treatment of children with growth failure associated with chronic renal insufficency.

Exclusivity Type: Orphan Drug Exclusivity Dec 30, 2003 Orphan Designation: Treatment of short stature associated with Turner's syndrome.
Approved Labeled Indication: Treatment of growth failure associated with Turner syndrome.

Exclusivity Type: Orphan Drug Exclusivity Dec 15, 2004 Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 17, 1992	Orphan Designation: For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Exclusivity Type: Orphan Drug Exclusivity	Nov 17, 2000	Orphan Designation: Treatment of growth retardation associated with chronic renal failure. Approved Labeled Indication: Treatment of children with growth failure associated with chronic renal insufficency.
Exclusivity Type: Orphan Drug Exclusivity	Dec 30, 2003	Orphan Designation: Treatment of short stature associated with Turner's syndrome. Approved Labeled Indication: Treatment of growth failure associated with Turner syndrome.
Exclusivity Type: Orphan Drug Exclusivity	Dec 15, 2004	Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.

Genentech, Inc.
Perjeta (Injection) (Intravenous) pertuzumab
NDA Applicant: Genentech, Inc. BLA No.: 125409 Prod. No.: 001 Rx (420MG/14ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Ref. Product Exclusivity Jun 8, 2024

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Ref. Product Exclusivity	Jun 8, 2024

Genentech, Inc.
Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
NDA Applicant: Genentech, Inc. BLA No.: 761121 Prod. No.: 001 Rx (140MG); 002 Rx (30MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 10, 2026 Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
Exclusivity Protected Indication: In combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.

Exclusivity Type: Orphan Drug Exclusivity Apr 19, 2030 Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater
Exclusivity Protected Indication: treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) and who have an International Prognostic Index score of 2 or greater

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 10, 2026	Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Exclusivity Protected Indication: In combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
Exclusivity Type: Orphan Drug Exclusivity	Apr 19, 2030	Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater Exclusivity Protected Indication: treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) and who have an International Prognostic Index score of 2 or greater

Genentech, Inc.
Pulmozyme (Solution) (Inhalation) dornase alfa
NDA Applicant: Genentech, Inc. BLA No.: 103532 Prod. No.: 001 Rx (2.5MG/2.5ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 30, 2000 Orphan Designation: To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis.
Approved Labeled Indication: In conjunction with standard therapies in the management of cystic fibrosis patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 30, 2000	Orphan Designation: To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis. Approved Labeled Indication: In conjunction with standard therapies in the management of cystic fibrosis patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function.

Genentech, Inc.
Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: Genentech, Inc. BLA No.: 103705 Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 26, 2004 Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma
Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma

Exclusivity Type: Orphan Drug Exclusivity Feb 18, 2017 Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide

Exclusivity Type: Orphan Drug Exclusivity Apr 19, 2018 Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). )

Exclusivity Type: Orphan Drug Exclusivity Sep 27, 2026 Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA)
Exclusivity Protected Indication: indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

Exclusivity Type: Orphan Drug Exclusivity Dec 2, 2028 Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma
Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy
Exclusivity Protected Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 26, 2004	Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma
Exclusivity Type: Orphan Drug Exclusivity	Feb 18, 2017	Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide
Exclusivity Type: Orphan Drug Exclusivity	Apr 19, 2018	Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). )
Exclusivity Type: Orphan Drug Exclusivity	Sep 27, 2026	Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA) Exclusivity Protected Indication: indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Exclusivity Type: Orphan Drug Exclusivity	Dec 2, 2028	Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy Exclusivity Protected Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 22, 2024	Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens Exclusivity Protected Indication: Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
Exclusivity Type: Orphan Drug Exclusivity	Jun 22, 2024	Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL) Approved Labeled Indication: Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide Exclusivity Protected Indication: Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide
Exclusivity Type: Orphan Drug Exclusivity	Jun 22, 2024	Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therap; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

Genentech, Inc.
Tecentriq (Injection) (Intravenous) atezolizumab
NDA Applicant: Genentech, Inc. BLA No.: 761034 Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Mar 18, 2026 Orphan Designation: Treatment of small cell lung cancer (SCLC)
Approved Labeled Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
Exclusivity Protected Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)

Exclusivity Type: Orphan Drug Exclusivity Jul 30, 2027 Orphan Designation: Treatment of Stage llb, llc, lll and IV melanoma
Approved Labeled Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Exclusivity Protected Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma

Exclusivity Type: Orphan Drug Exclusivity Dec 9, 2029 Orphan Designation: treatment of soft tissue sarcoma
Approved Labeled Indication: as a single agent for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)
Exclusivity Protected Indication: treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Mar 18, 2026	Orphan Designation: Treatment of small cell lung cancer (SCLC) Approved Labeled Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) Exclusivity Protected Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
Exclusivity Type: Orphan Drug Exclusivity	Jul 30, 2027	Orphan Designation: Treatment of Stage llb, llc, lll and IV melanoma Approved Labeled Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Exclusivity Protected Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Exclusivity Type: Orphan Drug Exclusivity	Dec 9, 2029	Orphan Designation: treatment of soft tissue sarcoma Approved Labeled Indication: as a single agent for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) Exclusivity Protected Indication: treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)

Genzyme Corporation
Campath; Lemtrada (Injection) (Intravenous) alemtuzumab
NDA Applicant: Genzyme Corporation BLA No.: 103948 Prod. No.: 002 Rx (12MG/1.2ML (10MG/ML)); 003 Rx (30MG/1ML) BLA No.: 103948 Prod. No.: 001 Disc (30MG (10MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 7, 2008 Orphan Designation: Treatment of chronic lymphocytic leukemia.
Approved Labeled Indication: The treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 7, 2008	Orphan Designation: Treatment of chronic lymphocytic leukemia. Approved Labeled Indication: The treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy.

Genzyme Corporation
Cerezyme (For Injection) (Intravenous) imiglucerase
NDA Applicant: Genzyme Corporation BLA No.: 020367 Prod. No.: 002 Rx (400UNITS/VIAL) BLA No.: 020367 Prod. No.: 001 Disc (200UNITS/VIAL)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 23, 2001 Orphan Designation: Replacement therapy in patients with types I, II, and III Gaucher's disease.
Approved Labeled Indication: Enzyme replacement therapy in patients with type I Gaucher's disease.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 23, 2001	Orphan Designation: Replacement therapy in patients with types I, II, and III Gaucher's disease. Approved Labeled Indication: Enzyme replacement therapy in patients with type I Gaucher's disease.

Genzyme Corporation
Fabrazyme (For Injection) (Intravenous) agalsidase beta
NDA Applicant: Genzyme Corporation BLA No.: 103979 Prod. No.: 001 Rx (35MG); 002 Rx (5MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Apr 24, 2010 Orphan Designation: Treatment of Fabry's disease.
Approved Labeled Indication: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types

Exclusivity Type: Orphan Drug Exclusivity Mar 11, 2028 Orphan Designation: Treatment of Fabry's disease.
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease
Exclusivity Protected Indication: treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 24, 2010	Orphan Designation: Treatment of Fabry's disease. Approved Labeled Indication: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
Exclusivity Type: Orphan Drug Exclusivity	Mar 11, 2028	Orphan Designation: Treatment of Fabry's disease. Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease Exclusivity Protected Indication: treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease

Genzyme Corporation
Myozyme (For Injection) (Intravenous) alglucosidase alfa
NDA Applicant: Genzyme Corporation BLA No.: 125141 Prod. No.: 001 Disc (50MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Apr 28, 2013 Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 28, 2013	Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Genzyme Corporation
Thyrogen (For Injection) (Intramuscular) thyrotropin alfa
NDA Applicant: Genzyme Corporation BLA No.: 020898 Prod. No.: 001 Rx (0.9MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 30, 2005 Orphan Designation: As an adjunct in the diagnosis of thyroid cancer.
Approved Labeled Indication: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer.

Exclusivity Type: Orphan Drug Exclusivity Dec 14, 2014 Orphan Designation: Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid
Approved Labeled Indication: For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 30, 2005	Orphan Designation: As an adjunct in the diagnosis of thyroid cancer. Approved Labeled Indication: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer.
Exclusivity Type: Orphan Drug Exclusivity	Dec 14, 2014	Orphan Designation: Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid Approved Labeled Indication: For use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer

Genzyme Corporation
Xenpozyme (For Injection) (Intravenous) olipudase alfa-rpcp
NDA Applicant: Genzyme Corporation BLA No.: 761261 Prod. No.: 001 Rx (20MG); 002 Rx (4MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 31, 2029 Orphan Designation: Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease)
Approved Labeled Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients
Exclusivity Protected Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 31, 2029	Orphan Designation: Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease) Approved Labeled Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients Exclusivity Protected Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients

GlaxoSmithKline Biologicals
Arexvy (For Injection) (Intramuscular) Respiratory Syncytial Virus Vaccine, Adjuvanted
NDA Applicant: GlaxoSmithKline Biologicals BLA No.: 125775 Prod. No.: 001 Rx (120UG/.5ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Ref. Product Exclusivity May 3, 2035

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Ref. Product Exclusivity	May 3, 2035

GlaxoSmithKline Intellectual Property Development Ltd. England
Blenrep (For Injection) (Intravenous) belantamab mafodotin-blmf
NDA Applicant: GlaxoSmithKline Intellectual Property Development Ltd. England BLA No.: 761158 Prod. No.: 001 Disc (100MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 5, 2027 Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 5, 2027	Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

GlaxoSmithKline LLC
Bexxar (Injection) (Intravenous) tositumomab and iodine I-131 tositumomab
NDA Applicant: GlaxoSmithKline LLC BLA No.: 125011 Prod. No.: 001 Disc (35MG); 002 Disc (225MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 27, 2010 Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma.
Approved Labeled Indication: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 27, 2010	Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma. Approved Labeled Indication: Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy

GlaxoSmithKline LLC
Nucala (For Injection) (Subcutaneous) mepolizumab
NDA Applicant: GlaxoSmithKline LLC BLA No.: 125526 Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 12, 2024 Orphan Designation: Treatment of Churg-Strauss Syndrome
Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)

Exclusivity Type: Orphan Drug Exclusivity Sep 25, 2027 Orphan Designation: For treatment of hypereosinophilic syndrome
Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 12, 2024	Orphan Designation: Treatment of Churg-Strauss Syndrome Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Type: Orphan Drug Exclusivity	Sep 25, 2027	Orphan Designation: For treatment of hypereosinophilic syndrome Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

GlaxoSmithKline LLC
Nucala (For Injection) (Subcutaneous) mepolizumab
NDA Applicant: GlaxoSmithKline LLC BLA No.: 761122 Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 12, 2024 Orphan Designation: Treatment of Churg-Strauss Syndrome
Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)

Exclusivity Type: Orphan Drug Exclusivity Sep 25, 2027 Orphan Designation: For treatment of hypereosinophilic syndrome
Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause
Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 12, 2024	Orphan Designation: Treatment of Churg-Strauss Syndrome Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA)
Exclusivity Type: Orphan Drug Exclusivity	Sep 25, 2027	Orphan Designation: For treatment of hypereosinophilic syndrome Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause

Grifols Biologicals LLC
Alphanate (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
NDA Applicant: Grifols Biologicals LLC BLA No.: 102475 Prod. No.: 001 Rx (250IU); 002 Rx (1000IU); 003 Rx (1500IU); 004 Rx (500IU); 005 Rx (2000IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jan 31, 2014 Orphan Designation: Treatment of von Willebrand's disease
Approved Labeled Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jan 31, 2014	Orphan Designation: Treatment of von Willebrand's disease Approved Labeled Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Grifols Biologicals LLC
Alphanine, Alphanine Hp, Alphanine Sd (Injection) (Intravenous) Coagulation Factor IX (Human)
NDA Applicant: Grifols Biologicals LLC BLA No.: 103249 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 004 Rx (1500IU) BLA No.: 103249 Prod. No.: 003 Disc (250IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 31, 1997 Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 31, 1997	Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Grifols Therapeutics LLC
Gammaked, Gamunex-C (Injection) (Intravenous; Subcutaneous) Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
NDA Applicant: Grifols Therapeutics LLC BLA No.: 125046 Prod. No.: 001 Rx (2.5G); 002 Rx (5G); 003 Rx (10G); 004 Rx (1G); 005 Rx (20G); 006 Rx (40G); 007 Rx (2.5G); 008 Rx (5G); 009 Rx (10G); 010 Rx (20G); 011 Rx (40G)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Sep 12, 2015 Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Sep 12, 2015	Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Grifols Therapeutics LLC
Prolastin, Prolastin-C (For Injection) (Intravenous) Alpha-1-Proteinase Inhibitor (Human)
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103174 Prod. No.: 001 Rx (1000MG); 003 Rx (1000MG/20ML); 004 Rx (4000MG/80ML); 005 Rx (500MG/10ML) BLA No.: 103174 Prod. No.: 002 Disc (500MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 2, 1994 Orphan Designation: For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state.
Approved Labeled Indication: For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 2, 1994	Orphan Designation: For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state. Approved Labeled Indication: For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema.

Grifols Therapeutics LLC
Thrombate Iii (For Injection) (Intravenous) Antithrombin III (Human)
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103196 Prod. No.: 001 Rx (500IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 30, 1998 Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.