Tradenames starting with "B"

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


BabyBig (For Injection) (Intravenous) Botulism Immune Globulin Intravenous (Human)
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.

Bat (Solution) (Intravenous) Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
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

Bavencio (Injection) (Intravenous) avelumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == programmed death ligand-1 (PD-L1) blocking antibody
NDA Applicant: EMD Serono, Inc.      BLA No.: 761049  Prod. No.: 001 Rx (200MG/10ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 23, 2024Orphan Designation: Treatment of merkel cell carcinoma.
Approved Labeled Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma
Exclusivity Protected Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma

Berinert (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: CSL Behring GmbH      BLA No.: 125287  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 8, 2016Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema.
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema.

Besponsa (For Injection) (Intravenous) inotuzumab ozogamicin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD22-directed antibody-drug conjugate (ADC)
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 761040  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 17, 2024Orphan Designation: Treatment of B-cell acute lymphoblastic leukemia
Approved Labeled Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Exclusivity Protected Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Besremi (Injection) (Subcutaneous) ropeginterferon alfa-2b-njft
Drug Classes: interferon alfa-2b
NDA Applicant: PharmaEssentia Corporation      BLA No.: 761166  Prod. No.: 001 Rx (500MCG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 12, 2028Orphan Designation: Treatment of polycythemia vera
Approved Labeled Indication: Treatment of adults with polycythemia vera
Exclusivity Protected Indication: Treatment of adults with polycythemia vera

Betaseron (For Injection) (Subcutaneous) interferon beta-1b
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc.      BLA No.: 103471  Prod. No.: 001 Rx (0.3MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 23, 2000Orphan Designation: Treatment of multiple sclerosis.
Approved Labeled Indication: In ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations.

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

Biothrax (Injection) (Intramuscular; Subcutaneous) Anthrax Vaccine Adsorbed
NDA Applicant: Emergent BioDefense Operations Lansing LLC      BLA No.: 103821  Prod. No.: 001 Rx (0.5ML); 002 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 23, 2022Orphan Designation: For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure
Approved Labeled Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.
Exclusivity Protected Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

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

Blincyto (For Injection) (Intravenous) blinatumomab
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

Botox Cosmetic (For Injection) (Intramuscular; Injection, Intramuscular, Intradermal, Intradetrusor) onabotulinumtoxinA
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: Allergan, Inc.      BLA No.: 103000  Prod. No.: 001 Rx (50UNITS); 002 Rx (100UNITS); 004 Rx (100UNITS); 005 Rx (200UNITS) BLA No.: 103000  Prod. No.: 003 Disc (50UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2026Orphan 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.

Breyanzi (Injection) (Intravenous) lisocabtagene maraleucel
NDA Applicant: Juno Therapeutics, Inc. a Bristol Myer-Squibb Company      BLA No.: 125714  Prod. No.: 001 Rx (4.6ML/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of primary mediastinal large B-cell lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of follicular lymphoma (FL)
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy

Brineura (Injection) (Intraventricular) cerliponase alfa
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal N-terminal tripeptidyl peptidase
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 761052  Prod. No.: 001 Rx (150MG/5ML (30MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 27, 2024Orphan Designation: Treatment of neuronal ceroid lipofuscinosis type 2
Approved Labeled Indication: To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Exclusivity Protected Indication: To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.



Last edited: 15 November 2022
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