Generic names starting with "B"

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.


basiliximab (For Injection) (Intravenous) Simulect
Drug Classes: Immunological Agents:Immunosuppressants == interleukin-2 receptor blocking antibody
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 103764  Prod. No.: 001 Rx (20MG); 002 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 12, 2005Orphan Designation: Prophylaxis of solid organ rejection.
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

belantamab mafodotin-blmf (For Injection) (Intravenous) Blenrep
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

belatacept (For Injection) (Intravenous) Nulojix
Drug Classes: Immunological Agents:Immunological Agents, Other == selective T-cell costimulation blocker
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125288  Prod. No.: 001 Rx (250MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2018Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients
Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants

beractant (Suspension) (Intratracheal) Survanta
NDA Applicant: AbbVie Inc.      BLA No.: 020032  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (200MG/8ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 2, 1998Orphan 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.

betibeglogene autotemcel (For Injection) (Intravenous) Zynteglo
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 17, 2034 

bevacizumab (Injection) (Intravenous) Avastin
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.

blinatumomab (For Injection) (Intravenous) Blincyto
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == bispecific CD19-directed CD3 T-cell engager
NDA Applicant: Amgen, Inc.      BLA No.: 125557  Prod. No.: 001 Rx (35MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 3, 2021Orphan Designation: Treatment of acute lymphocytic leukemia
Approved Labeled Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Exclusivity Protected Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2023Orphan Designation: Treatment of acute lymphocytic leukemia
Approved Labeled Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Exclusivity Protected Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients weighing less than 45 kg
Exclusivity Type: Orphan Drug ExclusivityJul 11, 2024Orphan Designation: Treatment of acute lymphocytic leukemia
Approved Labeled Indication: treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children
Exclusivity Protected Indication: treatment of Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children
Exclusivity Type: Orphan Drug ExclusivityMar 29, 2025Orphan Designation: Treatment of acute lymphocytic leukemia
Approved Labeled Indication: BLINCYTO_ is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
Exclusivity Protected Indication: For the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children

Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (Solution) (Intravenous) Bat
NDA Applicant: Emergent BioSolutions Canada Inc.      BLA No.: 125462  Prod. No.: 001 Rx (>4500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 22, 2020Orphan Designation: Treatment of botulism.
Approved Labeled Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G in adults and pediatric patients.
Exclusivity Protected Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients

Botulism Immune Globulin Intravenous (Human) (For Injection) (Intravenous) BabyBig
NDA Applicant: California Department of Public Health (CDPH)      BLA No.: 125034  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2010Orphan Designation: Treatment of infant botulism.
Approved Labeled Indication: Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.

brentuximab vedotin (For Injection) (Intravenous) Adcetris
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD30-directed antibody-drug conjugate
NDA Applicant: Seagen Inc.      BLA No.: 125388  Prod. No.: 001 Rx (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
Exclusivity Type: Orphan Drug ExclusivityAug 17, 2022Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of mycosis fungoides
Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders
Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityMar 20, 2025Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Protected Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2025Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

Brexucabtagene Autoleucel (For Injection) (Intravenous) Tecartus
NDA Applicant: Kite Pharma Inc.      BLA No.: 125703  Prod. No.: 001 Rx (2×10^6 CAR-positive viable T cells per kg body weight)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 24, 2027Orphan Designation: Treatment of mantle cell lymphoma.
Approved Labeled Indication: TECARTUS_ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Exclusivity Protected Indication: TECARTUS_ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Exclusivity Type: Orphan Drug ExclusivityOct 1, 2028Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL)
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)

burosumab-twza (Injection) (Subcutaneous) Crysvita
NDA Applicant: Kyowa Kirin, Inc.      BLA No.: 761068  Prod. No.: 001 Rx (10MG/ML); 002 Rx (20MG/ML); 003 Rx (30MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2025Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Protected Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Type: Orphan Drug ExclusivitySep 27, 2026Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Exclusivity Protected Indication: For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age
Exclusivity Type: Orphan Drug ExclusivityJun 18, 2027Orphan Designation: Treatment of tumor-induced osteomalacia (TIO) syndrome
Approved Labeled Indication: Crysvita (burosumab-twza) is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
Exclusivity Protected Indication: For the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older



Last edited: 15 November 2022
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