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.
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 6, 2025 | Orphan Designation: Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy Approved Labeled Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Exclusivity Protected Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. |
ibritumomab tiuxetan (Injection) (Intravenous) Zevalin
NDA Applicant: Acrotech Biopharma Inc. BLA No.: 125019 Prod. No.: 001 Rx (3.2MG/2ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Feb 19, 2009 | Orphan Designation: Treatment of B-cell non-Hodgkin's lymphoma. Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma |
idarucizumab (Injection) (Intravenous) Praxbind
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761025 Prod. No.: 001 Rx (2.5G/50ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Oct 16, 2022 | Orphan Designation: To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure Approved Labeled Indication: For use in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding Exclusivity Protected Indication: For use in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding |
idecabtagene vicleucel (Injection) (Intravenous) Abecma
NDA Applicant: Celgene Corporation, a Bristol-Myers Squibb Company BLA No.: 125736 Prod. No.: 001 Rx (150 TO 540 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS IN ONE OR MORE INFUSION)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 26, 2028 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody |
idursulfase (Injection) (Intravenous) Elaprase
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125151 Prod. No.: 001 Rx (6MG/3ML (2MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2013 | Orphan Designation: Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome) Approved Labeled Indication: Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Idursulfase has been shown to improve walking capacity in these patients |
imiglucerase (For Injection) (Intravenous) Cerezyme
NDA Applicant: Genzyme Corporation BLA No.: 020367 Prod. No.: 002 Rx (400UNITS/VIAL) BLA No.: 020367 Prod. No.: 001 Disc (200UNITS/VIAL)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | May 23, 2001 | Orphan Designation: Replacement therapy in patients with types I, II, and III Gaucher's disease. Approved Labeled Indication: Enzyme replacement therapy in patients with type I Gaucher's disease. |
Immune Globulin Infusion (Human) (Injection) (Intravenous, Subcutaneous) Gammagard Liquid
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125105 Prod. No.: 001 Rx (10% MG/ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2019 | Orphan Designation: Treatment of multifocal motor neuropathy Approved Labeled Indication: Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). |
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified (Injection) (Intravenous; Subcutaneous) Gammaked, Gamunex-C
NDA Applicant: Grifols Therapeutics LLC BLA No.: 125046 Prod. No.: 001 Rx (2.5G); 002 Rx (5G); 003 Rx (10G); 004 Rx (1G); 005 Rx (20G); 006 Rx (40G); 007 Rx (2.5G); 008 Rx (5G); 009 Rx (10G); 010 Rx (20G); 011 Rx (40G)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Sep 12, 2015 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Immune Globulin Intravenous (Human) (Injection) (Intravenous) Octagam
NDA Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H. BLA No.: 125062 Prod. No.: 001 Rx (5% 5.0G); 002 Rx (5% 1.0G); 003 Rx (5% 10G); 004 Rx (5% 2.5G); 005 Rx (5% 25G); 006 Rx (10% 20G); 007 Rx (10% 5G); 008 Rx (10% 2G); 009 Rx (10% 10G)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jul 15, 2028 | Orphan Designation: Treatment of dermatomyositis Approved Labeled Indication: Treatment of dermatomyositis in adults Exclusivity Protected Indication: Treatment of dermatomyositis in adults |
Immune Globulin Intravenous (Human) (Injection) (Intravenous) Bivigam
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 |
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Pat. No. 11548932 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 |
Immune Globulin Subcutaneous (Human), 20% Liquid (Injection) (Subcutaneous) Hizentra
NDA Applicant: CSL Behring AG BLA No.: 125350 Prod. No.: 001 Rx (2G); 002 Rx (1G); 003 Rx (10G); 004 Rx (4G)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 15, 2025 | Orphan Designation: Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) Approved Labeled Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. Exclusivity Protected Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment |
inebilizumab-cdon (Injection) (Intravenous) Uplizna
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 761142 Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jun 11, 2027 | Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders Approved Labeled Indication: Uplizna is indicated for for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Exclusivity Protected Indication: Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. |
infliximab (For Injection) (Intravenous) Remicade
NDA Applicant: Janssen Biotech, Inc. BLA No.: 103772 Prod. No.: 001 Rx (100MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Aug 24, 2005 | Orphan Designation: Treatment of Crohn's disease Approved Labeled Indication: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s). |
Exclusivity Type: Orphan Drug Exclusivity | May 19, 2013 | Orphan Designation: Treatment of pediatric (0 to 16 years of age) Crohn's Disease Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy |
Exclusivity Type: Orphan Drug Exclusivity | Sep 23, 2018 | Orphan Designation: Treatment of pediatric (0 to 16 years of age) ulcerative colitis Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy |
Influenza Vaccine (Injection) (Intramuscular) Flublok
NDA Applicant: Protein Sciences Corporation BLA No.: 125285 Prod. No.: 002 Rx (180UG/.5ML) BLA No.: 125285 Prod. No.: 001 Disc (135UG/.5ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Ref. Product Exclusivity | Jan 16, 2025 |
inotuzumab ozogamicin (For Injection) (Intravenous) Besponsa
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 761040 Prod. No.: 001 Rx (0.9MG)
Exclusivity | Expiration | Exclusivity Description |
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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) |
insulin glargine-yfgn (Injection) (Subcutaneous) Semglee
NDA Applicant: Mylan Pharmaceuticals Inc. BLA No.: 761201 Prod. No.: 001 Rx (1,000UNITS/10ML (100UNITS/ML)); 002 Rx (300UNITS/3ML (100UNITS/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: 1st Interchangeable Exclusivity | Nov 15, 2022 |
interferon alfa-2a (For Injection) (Subcutaneous) Roferon-A
NDA Applicant: Hoffmann-La Roche Inc. BLA No.: 103145 Prod. No.: 001 Disc (3MIU/0.5ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 21, 1995 | Orphan Designation: Treatment of AIDS related Kaposi's sarcoma. |
interferon alfa-2b (For Injection) (Intramuscular, Intravenous, Subcutaneous; Subcutaneous, Intravenous, Intralesional, Intramuscular; Subcutaneous, Intramuscular; Intralesional, Intramuscular, Subcutaneous) Intron A
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 103132 Prod. No.: 001 Disc (3MIU); 002 Disc (5MIU); 003 Disc (10MIU); 004 Disc (25MIU); 005 Disc (18MIU); 006 Disc (50MIU); 007 Disc (3MIU); 008 Disc (5MIU); 009 Disc (10MIU); 010 Disc (18MIU); 011 Disc (25MIU); 012 Disc (3MIU); 013 Disc (5MIU); 014 Disc (10MIU)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 21, 1995 | Orphan Designation: Treatment of AIDS-related Kaposi's sarcoma. Approved Labeled Indication: Treatment of selected patients with AIDS-related Kaposi's sarcoma. |
interferon beta-1a (For Injection) (Intramuscular) Avonex
NDA Applicant: Biogen Inc. BLA No.: 103628 Prod. No.: 002 Rx (30MCG/0.5ML); 003 Rx (30MCG/0.5ML) BLA No.: 103628 Prod. No.: 001 Disc (30MCG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | May 17, 2003 | Orphan Designation: Treatment of multiple sclerosis. Approved Labeled Indication: Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. |
interferon beta-1b (For Injection) (Subcutaneous) Betaseron
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. |
interferon gamma-1b (Injection) (Subcutaneous) Actimmune
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 103836 Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 20, 1997 | Orphan Designation: Treatment of chronic granulomatous disease. |
Exclusivity Type: Orphan Drug Exclusivity | Feb 10, 2007 | Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis. Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis. |
ipilimumab (Injection) (Intravenous) Yervoy
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125377 Prod. No.: 001 Rx (50MG/10ML (5MG/ML)); 002 Rx (200MG/40ML (5MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 25, 2018 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: Treatment of unresectable or metastatic melanoma |
Exclusivity Type: Orphan Drug Exclusivity | Oct 28, 2022 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy. Exclusivity Protected Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy. |
Exclusivity Type: Orphan Drug Exclusivity | Jul 21, 2024 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older) Exclusivity Protected Indication: treatment of unresectable or metastatic melanoma in pediatric patients (12 years and older). |
Exclusivity Type: Orphan Drug Exclusivity | Oct 2, 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. |
isatuximab-irfc (Injection) (Intravenous) Sarclisa
NDA Applicant: Sanofi-Aventis U.S. LLC BLA No.: 761113 Prod. No.: 001 Rx (100MG/5ML (20MG/ML)); 002 Rx (500MG/25ML (20MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 2, 2027 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Exclusivity Protected Indication: Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. |
Exclusivity Type: Orphan Drug Exclusivity | Mar 31, 2028 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 prior line of therapy, and for treatment of adult patients with relapsed or refractory multiple myeloma who have received 2 to 3 prior therapies excluding patients covered by the indication approved on March 2, 2020 |