Company 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.

IDEC Pharmaceuticals Corp.
Rituxan (Injection) (Intravenous) rituximab
NDA Applicant: IDEC Pharmaceuticals Corp.      BLA No.: 103737  Prod. No.: 001 Disc (100MG/10ML (10MG/ML)); 002 Disc (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 26, 2004Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma
Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma
Exclusivity Type: Orphan Drug ExclusivityFeb 18, 2017Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide
Exclusivity Type: Orphan Drug ExclusivityApr 19, 2018Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). )
Exclusivity Type: Orphan Drug ExclusivitySep 27, 2026Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA)
Exclusivity Protected Indication: indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Exclusivity Type: Orphan Drug ExclusivityDec 2, 2028Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma
Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy
Exclusivity Protected Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL)

Immunex Corporation
Enbrel; Enbrel Mini (For Injection) (Subcutaneous) etanercept
NDA Applicant: Immunex Corporation      BLA No.: 103795  Prod. No.: 002 Rx (25MG); 003 Rx (50MG/ML); 004 Rx (25MG/0.5ML); 005 Rx (50MG/ML); 006 Rx (50MG/ML); 007 Rx (25MG/0.5ML) BLA No.: 103795  Prod. No.: 001 Disc (25MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 27, 2006Orphan Designation: Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older

Immunocore Limited
Kimmtrak (Injection) (Intravenous) tebentafusp-tebn
NDA Applicant: Immunocore Limited      BLA No.: 761228  Prod. No.: 001 Rx (100MCG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 25, 2029Orphan Designation: Treatment of uveal melanoma
Approved Labeled Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
Exclusivity Protected Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

ImmunoGen, Inc.
Elahere (Injection) (Intravenous) mirvetuximab soravtansine-gynx
NDA Applicant: ImmunoGen, Inc.      BLA No.: 761310  Prod. No.: 001 Rx (100MG/20ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 14, 2029Orphan Designation: Treatment of ovarian cancer
Approved Labeled Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
Exclusivity Protected Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian cancer, as detected by an FDA-approved test, who have received one to three prior systemic treatment regimens

Incyte Corporation
Zynyz (Injection) (Intravenous) retifanlimab-dlwr
NDA Applicant: Incyte Corporation      BLA No.: 761334  Prod. No.: 001 Rx (500MG/20ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 22, 2030Orphan Designation: Treatment of Merkel cell carcinoma
Approved Labeled Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
Exclusivity Protected Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)

Innate Pharma, Inc.
Lumoxiti (For Injection) (Intravenous) moxetumomab pasudotox-tdfk
NDA Applicant: Innate Pharma, Inc.      BLA No.: 761104  Prod. No.: 001 Disc (1MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 13, 2025Orphan Designation: Treatment of hairy cell leukemia
Approved Labeled Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Exclusivity Protected Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Insmed Incorporated
Iplex (Injection) (Subcutaneous) mecasermin rinfabate
NDA Applicant: Insmed Incorporated      BLA No.: 021884  Prod. No.: 001 Disc (36MG/0.6ML (60MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2012Orphan Designation: Treatment of growth hormone insensitivity syndrome (GHIS)
Approved Labeled Indication: Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone

Ipsen Biopharm Limited
Dysport (For Injection) (Intramuscular) abobotulinumtoxinA
NDA Applicant: Ipsen Biopharm Limited      BLA No.: 125274  Prod. No.: 001 Rx (300UNITS); 002 Rx (500UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 29, 2023Orphan Designation: Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.
Approved Labeled Indication: Treatment of lower limb spasticity in pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older

Ipsen Biopharmaceuticals, Inc.
Increlex (Injection) (Subcutaneous) mecasermin
NDA Applicant: Ipsen Biopharmaceuticals, Inc.      BLA No.: 021839  Prod. No.: 001 Rx (40MG/4ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2012Orphan Designation: Treatment of growth hormone insensitivity syndrome.
Approved Labeled Indication: Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.


Last edited: 19 August 2023
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