Tradenames starting with "I"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Idelvion (For Injection) (Intravenous) Coagulation Factor IX (Recombinant), Albumin Fusion Protein
NDA Applicant: CSL Behring Lengnau AG BLA No.: 125582 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (2000IU); 004 Rx (250IU); 005 Rx (3500IU)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Mar 4, 2023	Orphan Designation: Treatment of patients with congenital factor IX deficiency (hemophilia B). Approved Labeled Indication: Indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Exclusivity Protected Indication: Indicated for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Ilaris (For Injection) (Subcutaneous) canakinumab
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 125319 Prod. No.: 001 Rx (150MG); 002 Rx (150MG/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 17, 2016 Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.

Exclusivity Type: Orphan Drug Exclusivity May 9, 2020 Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.
Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of familial mediterranean fever
Approved Labeled Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of TNF-receptor associated periodic syndrome (TRAPS)
Approved Labeled Indication: Indicated for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of hyperimmunoglobulinemia D and periodic fever syndrome
Approved Labeled Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Jun 16, 2027 Orphan Designation: Treatment of adult-onset Still's Disease
Approved Labeled Indication: ILARIS is indicated for the treatment of active Stills disease, including Adult-Onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: For the treatment of active adult-onset Stills Disease (AOSD).

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 17, 2016	Orphan Designation: Treatment of cryopyrin-associated periodic syndromes Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.
Exclusivity Type: Orphan Drug Exclusivity	May 9, 2020	Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis. Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Exclusivity Protected Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of familial mediterranean fever Approved Labeled Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients Exclusivity Protected Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of TNF-receptor associated periodic syndrome (TRAPS) Approved Labeled Indication: Indicated for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients Exclusivity Protected Indication: Indicated for treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of hyperimmunoglobulinemia D and periodic fever syndrome Approved Labeled Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients Exclusivity Protected Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Jun 16, 2027	Orphan Designation: Treatment of adult-onset Still's Disease Approved Labeled Indication: ILARIS is indicated for the treatment of active Stills disease, including Adult-Onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Exclusivity Protected Indication: For the treatment of active adult-onset Stills Disease (AOSD).

Imfinzi (Injection) (Intravenous) durvalumab
NDA Applicant: AstraZeneca UK Ltd BLA No.: 761069 Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Mar 27, 2027 Orphan Designation: Treatment of small cell lung cancer
Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Exclusivity Protected Indication: Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Exclusivity Type: Orphan Drug Exclusivity Sep 2, 2029 Orphan Designation: Treatment of biliary tract cancer
Approved Labeled Indication: In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)
Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)

Exclusivity Type: Orphan Drug Exclusivity Oct 21, 2029 Orphan Designation: Treatment of hepatocellular carcinoma
Approved Labeled Indication: In combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)
Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Mar 27, 2027	Orphan Designation: Treatment of small cell lung cancer Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Exclusivity Protected Indication: Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Exclusivity Type: Orphan Drug Exclusivity	Sep 2, 2029	Orphan Designation: Treatment of biliary tract cancer Approved Labeled Indication: In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC)
Exclusivity Type: Orphan Drug Exclusivity	Oct 21, 2029	Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)

Imjudo (Injection) (Intravenous) tremelimumab-actl
NDA Applicant: AstraZeneca AB BLA No.: 761289 Prod. No.: 001 Rx (25MG/1.25ML (20MG/ML)); 002 Rx (300MG/15ML (20MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 21, 2029 Orphan Designation: Treatment of hepatocellular carcinoma
Approved Labeled Indication: In combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)
Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 21, 2029	Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)

Imlygic (For Injection) (Intralesional) Talimogene laherparepvec
NDA Applicant: Amgen Inc. BLA No.: 125518 Prod. No.: 001 Rx (100 MILLION PFU/ML); 002 Rx (1 MILLION PFU/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 27, 2022 Orphan Designation: Treatment of stage IIb-stage IV melanoma
Approved Labeled Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery
Exclusivity Protected Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 27, 2022	Orphan Designation: Treatment of stage IIb-stage IV melanoma Approved Labeled Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery Exclusivity Protected Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery

Increlex (Injection) (Subcutaneous) mecasermin
NDA Applicant: Ipsen Biopharmaceuticals, Inc. BLA No.: 021839 Prod. No.: 001 Rx (40MG/4ML (10MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 30, 2012 Orphan 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 30, 2012	Orphan 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.

Inmazeb (Injection) (Intravenous) atoltivimab, maftivimab, and odesivimab-ebgn
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 761169 Prod. No.: 001 Rx (241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)); 002 Rx (483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 14, 2027 Orphan Designation: Treatment of ebola virus infection
Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 14, 2027	Orphan Designation: Treatment of ebola virus infection Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection

Intron A (For Injection) (Intramuscular, Intravenous, Subcutaneous; Subcutaneous, Intravenous, Intralesional, Intramuscular; Subcutaneous, Intramuscular; Intralesional, Intramuscular, Subcutaneous) interferon alfa-2b
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.

Iplex (Injection) (Subcutaneous) mecasermin rinfabate
NDA Applicant: Insmed Incorporated BLA No.: 021884 Prod. No.: 001 Disc (36MG/0.6ML (60MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 12, 2012 Orphan 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

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 12, 2012	Orphan 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

Ixiaro (Injection) (Intramuscular) Japanese Encephalitis Vaccine, Inactivated, Adsorbed
NDA Applicant: Valneva Austria GmbH BLA No.: 125280 Prod. No.: 001 Rx (0.5ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 17, 2020 Orphan Designation: Prevention of Japanese encephalitis virus in pediatric patients.
Approved Labeled Indication: IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.
Exclusivity Protected Indication: To extend the age range to include infants, children, and adolescents 2 months to less than 17 years of age for active immunization for the prevention of disease caused by Japanese encephalitis virus.