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))

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

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.

Exclusivity	Expiration	Exclusivity Description
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

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).

Exclusivity	Expiration	Exclusivity Description
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

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.

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

Pat. No. 11548932 Anti-VEGF protein compositions and methods for producing the same
Claim Types: Process
Pat. Sub. Date(s): None Aug 18, 2040

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

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

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

Exclusivity	Expiration	Exclusivity Description
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

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.

Exclusivity	Expiration	Exclusivity Description
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

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

Exclusivity	Expiration	Exclusivity Description
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

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

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)

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)

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

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.

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.

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.

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.

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.

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.

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

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

Exclusivity	Expiration	Exclusivity Description
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