Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2010 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 22, 2020 | Orphan 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
NDA Applicant: EMD Serono, Inc. BLA No.: 761049 Prod. No.: 001 Rx (200MG/10ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 23, 2024 | Orphan 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 |
Benefix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 103677 Prod. No.: 001 Rx (1000IU/ML); 002 Rx (500IU/ML); 003 Rx (250IU/ML); 004 Rx (2000IU/ML); 005 Rx (3000IU/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 11, 2004 | Orphan Designation: Treatment of hemophilia B Approved Labeled Indication: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings. |
Berinert (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
NDA Applicant: CSL Behring GmbH BLA No.: 125287 Prod. No.: 001 Rx (500U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 8, 2016 | Orphan 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
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 761040 Prod. No.: 001 Rx (0.9MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2024 | Orphan 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
NDA Applicant: PharmaEssentia Corporation BLA No.: 761166 Prod. No.: 001 Rx (500MCG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 12, 2028 | Orphan 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
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc. BLA No.: 103471 Prod. No.: 001 Rx (0.3MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 23, 2000 | Orphan 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
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 |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 23, 2022 | Orphan 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. |
Bivigam (Injection) (Intravenous) Immune Globulin Intravenous (Human)
NDA Applicant: ADMA Biologics, Inc. BLA No.: 125389 Prod. No.: 001 Rx (5GM/50ML) BLA No.: 125389 Prod. No.: 002 Disc (10GM/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11548932 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 |
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. |
Blincyto (For Injection) (Intravenous) blinatumomab
NDA Applicant: Amgen Inc. BLA No.: 125557 Prod. No.: 001 Rx (35MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 3, 2021 | Orphan 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 Exclusivity | Aug 30, 2023 | Orphan 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 Exclusivity | Jul 11, 2024 | Orphan 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 Exclusivity | Mar 29, 2025 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2026 | 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. |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan 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 Exclusivity | Feb 5, 2028 | Orphan 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 |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan 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 Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of follicular lymphoma (FL) Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of primary mediastinal large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), 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 who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) , primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
Brineura (Injection) (Intraventricular) cerliponase alfa
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 761052 Prod. No.: 001 Rx (150MG/5ML (30MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 27, 2024 | Orphan 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. |