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 |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Apr 9, 2005 | Orphan Designation: Treatment of congenital sucrase-isomaltase deficiency Approved Labeled Indication: Oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrease-isomaltase deficiency. |
sargramostim (For Injection) (Intravenous, Subcutaneous ) Leukine
NDA Applicant: Partner Therapeutics, Inc. BLA No.: 103362 Prod. No.: 001 Rx (250MCG) BLA No.: 103362 Prod. No.: 002 Disc (500MCG/ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 5, 1998 | Orphan Designation: Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment. |
Exclusivity Type: Orphan Drug Exclusivity | Sep 15, 2002 | Orphan Designation: To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia. Approved Labeled Indication: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. |
Exclusivity Type: Orphan Drug Exclusivity | Mar 29, 2025 | Orphan Designation: Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome) Approved Labeled Indication: LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). Exclusivity Protected Indication: to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]) |
satralizumab-mwge (Injection) (Subcutaneous) Enspryng
NDA Applicant: Genentech, Inc. BLA No.: 761149 Prod. No.: 001 Rx (120MG/ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Aug 14, 2027 | Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder Approved Labeled Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive Exclusivity Protected Indication: treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive |
sebelipase alfa (Injection) (Intravenous) Kanuma
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 125561 Prod. No.: 001 Rx (20MG/10ML (2MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Dec 8, 2022 | Orphan Designation: Treatment of lysosomal acid lipase deficiency Approved Labeled Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency Exclusivity Protected Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency |
siltuximab (For Injection) (Intravenous) Sylvant
NDA Applicant: EUSA Pharma (UK) Limited BLA No.: 125496 Prod. No.: 001 Rx (100MG); 002 Rx (400MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Apr 23, 2021 | Orphan Designation: Treatment of Castleman's disease Approved Labeled Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Exclusivity Protected Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. |
somatropin (For Injection) (Subcutaneous) Humatrope
NDA Applicant: Eli Lilly and Company BLA No.: 019640 Prod. No.: 005 Rx (6MG); 006 Rx (12MG); 007 Rx (24MG) BLA No.: 019640 Prod. No.: 001 Disc (2MG); 004 Disc (5MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 8, 1994 | Orphan Designation: For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone. |
Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 2003 | Orphan Designation: Treatment of short stature associated with Turner syndrome. Approved Labeled Indication: Treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. |
Exclusivity Type: Orphan Drug Exclusivity | Nov 1, 2013 | Orphan Designation: Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency Approved Labeled Indication: Treatment of short stature or growth failure in children with SHOX (short stature homeobox-containing gene) deficiency whose epiphyses are not closed |
somatropin (For Injection) (Subcutaneous) Nutropin
NDA Applicant: Genentech, Inc. BLA No.: 020168 Prod. No.: 001 Disc (5MG); 002 Disc (10MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Oct 17, 1992 | Orphan Designation: For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion. |
Exclusivity Type: Orphan Drug Exclusivity | Nov 17, 2000 | Orphan Designation: Treatment of growth retardation associated with chronic renal failure. Approved Labeled Indication: Treatment of children with growth failure associated with chronic renal insufficency. |
Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 2003 | Orphan Designation: Treatment of short stature associated with Turner's syndrome. Approved Labeled Indication: Treatment of growth failure associated with Turner syndrome. |
Exclusivity Type: Orphan Drug Exclusivity | Dec 15, 2004 | Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure. |
somatropin (For Injection) (Subcutaneous) Genotropin
NDA Applicant: Pharmacia & Upjohn Company LLC BLA No.: 020280 Prod. No.: 002 Rx (5MG); 003 Rx (0.6MG); 004 Rx (0.2MG); 005 Rx (0.8MG); 006 Rx (0.4MG); 007 Rx (12MG); 008 Rx (1MG); 009 Rx (1.2MG); 010 Rx (1.4MG); 011 Rx (1.6MG); 012 Rx (1.8MG); 013 Rx (2MG) BLA No.: 020280 Prod. No.: 001 Disc (1.5MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Oct 31, 2004 | Orphan Designation: Treatment of adults with growth hormone deficiency. |
Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2007 | Orphan Designation: Treatment of short stature in patients with Prader-Willi syndrome. Approved Labeled Indication: Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). |
Exclusivity Type: Orphan Drug Exclusivity | Jul 25, 2008 | Orphan Designation: Treatment of growth failure in children who were born small for gestational age. Approved Labeled Indication: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age. |
somatropin (For Injection) (Subcutaneous) Serostim
NDA Applicant: EMD Serono, Inc. BLA No.: 020604 Prod. No.: 001 Rx (6MG); 002 Rx (5MG); 003 Rx (4MG) BLA No.: 020604 Prod. No.: 005 Disc (6MG/0.5ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Aug 23, 2003 | Orphan Designation: Treatment of AIDS-associated catabolism/weight loss. Approved Labeled Indication: Treatment of AIDS wasting or cachexia. |
somatropin (Injection) (Subcutaneous) Norditropin
NDA Applicant: Novo Nordisk Inc. BLA No.: 021148 Prod. No.: 008 Rx (5MG/1.5ML); 009 Rx (10MG/1.5ML); 010 Rx (15MG/1.5ML); 011 Rx (30MG/3ML) BLA No.: 021148 Prod. No.: 001 Disc (5MG/1.5ML); 002 Disc (10MG/1.5ML); 003 Disc (15MG/1.5ML); 004 Disc (5MG/1.5ML); 005 Disc (10MG/1.5ML); 006 Disc (15MG/1.5ML); 007 Disc (30MG/3ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | May 31, 2014 | Orphan Designation: Treatment of short stature in patients with Noonan syndrome Approved Labeled Indication: Treatment of short stature in patients with Noonan syndrome |
spesolimab-sbzo (Injection) (Intravenous) Spevigo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761244 Prod. No.: 001 Rx (450MG/7.5ML (60MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Sep 1, 2029 | Orphan Designation: Treatment of generalized pustular psoriasis Approved Labeled Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults Exclusivity Protected Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults |
sutimlimab-jome (Injection) (Intravenous) Enjaymo
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 761164 Prod. No.: 001 Rx (1,100MG/22ML (50MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Feb 4, 2029 | Orphan Designation: Treatment of autoimmune hemolytic anemia Approved Labeled Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) Exclusivity Protected Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) |