Generic names starting with "S"

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.


sacrosidase (Solution For Oral) (Oral) Sucraid
NDA Applicant: QOL Medical, LLC      BLA No.: 020772  Prod. No.: 001 Rx (1,003,000IU/118ML (8,500IU/ML)); 002 Rx (17,000IU/2ML (8,500IU/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 9, 2005Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 5, 1998Orphan 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 ExclusivitySep 15, 2002Orphan 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 ExclusivityMar 29, 2025Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 14, 2027Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2022Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2021Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 8, 1994Orphan 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 ExclusivityDec 30, 2003Orphan 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 ExclusivityNov 1, 2013Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 17, 1992Orphan 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 ExclusivityNov 17, 2000Orphan 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 ExclusivityDec 30, 2003Orphan 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 ExclusivityDec 15, 2004Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 31, 2004Orphan Designation: Treatment of adults with growth hormone deficiency.
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2007Orphan 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 ExclusivityJul 25, 2008Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 23, 2003Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 31, 2014Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 1, 2029Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 4, 2029Orphan 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)



Last edited: 19 August 2023
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