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.


Genentech, Inc.
Actemra (; Injection) (; Intravenous) tocilizumab
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125276  Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan 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 ExclusivityAug 30, 2024Orphan 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 ExclusivityMar 4, 2028Orphan 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
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125472  Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan 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 ExclusivityAug 30, 2024Orphan 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 ExclusivityMar 4, 2028Orphan 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.
Avastin (Injection) (Intravenous) bevacizumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Genentech, Inc.      BLA No.: 125085  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography
Claim Types: Process
Pat. Sub. Date(s): None
Mar 7, 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 10, 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 3, 2031 
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None
Jul 7, 2028 
Pat. No. 9441035 Cell culture media and methods of antibody production
Claim Types: Process
Pat. Sub. Date(s): None
Apr 22, 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 13, 2032 
Pat. No. 9714293 Production of proteins in glutamine-free cell culture media
Claim Types: Process
Pat. Sub. Date(s): None
Aug 5, 2030 
Pat. No. 9795672 Treatment with anti-VEGF antibodies
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 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 25, 2031 
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 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 13, 2035 
Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization
Claim Types: Analytical procedure
Pat. Sub. Date(s): None
Jul 10, 2035 
Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells
Claim Types: Process
Pat. Sub. Date(s): None
Jul 30, 2035 
Pat. No. 10513697 CO.sub.2 profile cultivation
Claim Types: Process
Pat. Sub. Date(s): None
Sep 16, 2032 
Pat. No. 10662237 Method to improve virus filtration capacity
Claim Types: Process
Pat. Sub. Date(s): None
May 25, 2031 
Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 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 17, 2031 
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10906934 Protein purification methods
Claim Types: Process
Pat. Sub. Date(s): None
Oct 11, 2033 
Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None
Jul 7, 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 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 5, 2016Orphan Designation: Treatment of malignant glioma
Approved Labeled Indication: Treatment of glioblastoma with progressive disease following prior therapy
Exclusivity Type: Orphan Drug ExclusivityJul 31, 2016Orphan Designation: Treatment of renal cell carcinoma
Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa
Exclusivity Type: Orphan Drug ExclusivityNov 14, 2021Orphan 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 ExclusivityNov 14, 2021Orphan 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 ExclusivityNov 14, 2021Orphan 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 ExclusivityDec 6, 2023Orphan 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 ExclusivityDec 6, 2023Orphan 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 ExclusivityDec 6, 2023Orphan 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 ExclusivityJun 13, 2025Orphan 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 ExclusivityJun 13, 2025Orphan 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 ExclusivityJun 13, 2025Orphan 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 ExclusivityMay 29, 2027Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 14, 2027Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 125486  Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 1, 2020Orphan 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 ExclusivityFeb 26, 2023Orphan 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 ExclusivityNov 16, 2024Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2024Orphan 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 ExclusivityOct 4, 2025Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == HER2/neu receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 103792  Prod. No.: 002 Rx (150MG) BLA No.: 103792  Prod. No.: 001 Disc (420MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 20, 2017Orphan 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

Genentech, Inc.
Lucentis (Injection) (Intravitreal) ranibizumab
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Genentech, Inc.      BLA No.: 125156  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML)); 003 Rx (10MG/ML (0.5MG/0.05ML)); 004 Rx (6MG/ML (0.3MG/0.05ML))
PatentsExpirationPatented Use
Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins
Claim Types: Process
Pat. Sub. Date(s): None
Oct 31, 2021 
Pat. No. 6828121 Bacterial host strains
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Jul 7, 2022 
Pat. No. 6921659 Protease-deficient cells
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Oct 16, 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 7, 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 9, 2034 
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10112994 Methods of producing two chain proteins in bacteria
Claim Types: Process
Pat. Sub. Date(s): None
Nov 4, 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 18, 2033 
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 

Genentech, Inc.
Nutropin (For Injection) (Subcutaneous) somatropin
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == recombinant human growth hormone
NDA Applicant: Genentech, Inc.      BLA No.: 020168  Prod. No.: 001 Disc (5MG); 002 Disc (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 17, 1992Orphan 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 ExclusivityNov 17, 2000Orphan 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 ExclusivityDec 30, 2003Orphan 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 ExclusivityDec 15, 2004Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.

Genentech, Inc.
Perjeta (Injection) (Intravenous) pertuzumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == HER2/neu receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125409  Prod. No.: 001 Rx (420MG/14ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJun 8, 2024 

Genentech, Inc.
Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Genentech, Inc.      BLA No.: 761121  Prod. No.: 001 Rx (140MG); 002 Rx (30MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 10, 2026Orphan 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.

Genentech, Inc.
Pulmozyme (Solution) (Inhalation) dornase alfa
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == recombinant human deoxyribonuclease 1 (rhDNase) enzyme
NDA Applicant: Genentech, Inc.      BLA No.: 103532  Prod. No.: 001 Rx (2.5MG/2.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 30, 2000Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Immunological Agents:Immunosuppressants == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 103705  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 26, 2004Orphan 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 ExclusivityFeb 18, 2017Orphan 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 ExclusivityApr 19, 2018Orphan 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 ExclusivitySep 27, 2026Orphan 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)

Genentech, Inc.
Rituxan Hycela (Injection) (Subcutaneous) rituximab and hyaluronidase human
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Immunological Agents:Immunosuppressants == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 761064  Prod. No.: 001 Rx (1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML)); 002 Rx (1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2024Orphan 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 ExclusivityJun 22, 2024Orphan 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 ExclusivityJun 22, 2024Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human programmed death receptor-1 (PD-1)-blocking antibody
NDA Applicant: Genentech, Inc.      BLA No.: 761034  Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2026Orphan 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 ExclusivityJul 30, 2027Orphan 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

Genzyme Corporation
Campath; Lemtrada (Injection) (Intravenous) alemtuzumab
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == CD52-directed cytolytic monoclonal antibody
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 7, 2008Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glucocerebroside-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 020367  Prod. No.: 002 Rx (400UNITS/VIAL) BLA No.: 020367  Prod. No.: 001 Disc (200UNITS/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 23, 2001Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal neutral glycosphingolipid-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 103979  Prod. No.: 001 Rx (35MG); 002 Rx (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 24, 2010Orphan 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 ExclusivityMar 11, 2028Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal glycogen-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 125141  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 28, 2013Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 30, 2005Orphan 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 ExclusivityDec 14, 2014Orphan 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

GlaxoSmithKline Intellectual Property Development Ltd. England
Blenrep (For Injection) (Intravenous) belantamab mafodotin-blmf
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: GlaxoSmithKline Intellectual Property Development Ltd. England      BLA No.: 761158  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 5, 2027Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
Exclusivity Protected Indication: for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent

GlaxoSmithKline LLC
Bexxar (Injection) (Intravenous) tositumomab and iodine I-131 tositumomab
Drug Classes: CD20-directed radiotherapeutic antibody
NDA Applicant: GlaxoSmithKline LLC      BLA No.: 125011  Prod. No.: 001 Disc (35MG); 002 Disc (225MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 27, 2010Orphan 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
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan 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 ExclusivitySep 25, 2027Orphan 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
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan 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 ExclusivitySep 25, 2027Orphan 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)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 31, 2014Orphan 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)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 31, 1997Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 2, 1994Orphan 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)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == recombinant antithrombin
NDA Applicant: Grifols Therapeutics LLC      BLA No.: 103196  Prod. No.: 001 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 30, 1998Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.



Last edited: 15 November 2022
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