Generic names starting with "I"

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.


ibalizumab-uiyk (Injection) (Intravenous) Trogarzo
NDA Applicant: Theratechnologies Inc.      BLA No.: 761065  Prod. No.: 001 Rx (200MG/1.33ML (150MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 6, 2025Orphan 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
Drug Classes: CD20-directed radiotherapeutic antibody
NDA Applicant: Acrotech Biopharma LLC      BLA No.: 125019  Prod. No.: 001 Rx (3.2MG/2ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 19, 2009Orphan 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
Drug Classes: humanized monoclonal antibody fragment (Fab)
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761025  Prod. No.: 001 Rx (2.5G/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 16, 2022Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 26, 2028Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125151  Prod. No.: 001 Rx (6MG/3ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 24, 2013Orphan 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
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.

Immune Globulin Infusion (Human) (Injection) (Intravenous, Subcutaneous) Gammagard Liquid
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: Baxalta US Inc.      BLA No.: 125105  Prod. No.: 001 Rx (10% MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2019Orphan 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 Intravenous (Human) (Injection) (Intravenous) Octagam
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 15, 2028Orphan Designation: Treatment of dermatomyositis
Approved Labeled Indication: Treatment of dermatomyositis in adults
Exclusivity Protected Indication: Treatment of dermatomyositis in adults

Immune Globulin Subcutaneous (Human), 20% Liquid (Injection) (Subcutaneous) Hizentra
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: CSL Behring AG      BLA No.: 125350  Prod. No.: 001 Rx (2G); 002 Rx (1G); 003 Rx (10G); 004 Rx (4G)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 15, 2025Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 11, 2027Orphan 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
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 103772  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 24, 2005Orphan 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 ExclusivityMay 19, 2013Orphan 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 ExclusivitySep 23, 2018Orphan 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
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Protein Sciences Corporation      BLA No.: 125285  Prod. No.: 002 Rx (180UG/.5ML) BLA No.: 125285  Prod. No.: 001 Disc (135UG/.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJan 16, 2025 

inotuzumab ozogamicin (For Injection) (Intravenous) Besponsa
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)

insulin glargine-yfgn (Injection) (Subcutaneous) Semglee
Drug Classes: Blood Glucose Regulators:Antidiabetic Combinations == Blood Glucose Regulators:Insulins == insulin analog == long-acting human insulin analog
NDA Applicant: Mylan Pharmaceuticals Inc.      BLA No.: 761201  Prod. No.: 001 Rx (1,000UNITS/10ML (100UNITS/ML)); 002 Rx (300UNITS/3ML (100UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityNov 15, 2022 

interferon alfa-2a (For Injection) (Subcutaneous) Roferon-A
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Hoffmann-La Roche Inc.      BLA No.: 103145  Prod. No.: 001 Disc (3MIU/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 21, 1995Orphan 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
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Merck Sharp & Dohme Corp.      BLA No.: 103132  Prod. No.: 003 Rx (10MIU); 005 Rx (18MIU); 006 Rx (50MIU); 010 Rx (18MIU); 011 Rx (25MIU) BLA No.: 103132  Prod. No.: 001 Disc (3MIU); 002 Disc (5MIU); 004 Disc (25MIU); 007 Disc (3MIU); 008 Disc (5MIU); 009 Disc (10MIU); 012 Disc (3MIU); 013 Disc (5MIU); 014 Disc (10MIU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 21, 1995Orphan 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
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2003Orphan 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
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.

interferon gamma-1b (Injection) (Subcutaneous) Actimmune
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 103836  Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 20, 1997Orphan Designation: Treatment of chronic granulomatous disease.
Exclusivity Type: Orphan Drug ExclusivityFeb 10, 2007Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125377  Prod. No.: 001 Rx (50MG/10ML (5MG/ML)); 002 Rx (200MG/40ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 25, 2018Orphan 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 ExclusivityOct 28, 2022Orphan 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 ExclusivityJul 21, 2024Orphan 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 ExclusivityOct 2, 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.

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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 2, 2027Orphan 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 ExclusivityMar 31, 2028Orphan 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



Last edited: 15 November 2022
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