Company 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.


Sanofi Pasteur Inc.
Dengvaxia (For Injection) (Subcutaneous) Dengue Tetravalent Vaccine, Live
NDA Applicant: Sanofi Pasteur Inc.      BLA No.: 125682  Prod. No.: 001 Rx (4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityMay 1, 2031 

Sanofi Pasteur Inc.
Menquadfi (Injection) (Intramuscular) Meningococcal (Groups A, C, Y, W) Conjugate Vaccine
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Sanofi Pasteur Inc.      BLA No.: 125701  Prod. No.: 001 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJan 14, 2017 

Sanofi-Aventis U.S. LLC
Elitek (For Injection) (Intravenous) rasburicase
Drug Classes: Antineoplastics:Treatment Adjuncts
NDA Applicant: Sanofi-Aventis U.S. LLC      BLA No.: 103946  Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 12, 2009Orphan Designation: Treatment of malignancy-associated or chemotherapy-induced hyperuricemia.
Approved Labeled Indication: Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.

Sanofi-Aventis U.S. LLC
Sarclisa (Injection) (Intravenous) isatuximab-irfc
NDA Applicant: Sanofi-Aventis U.S. LLC      BLA No.: 761113  Prod. No.: 001 Rx (100MG/5ML (20MG/ML)); 002 Rx (500MG/25ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 2, 2027Orphan 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 ExclusivityMar 31, 2028Orphan 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

Seagen Inc.
Adcetris (For Injection) (Intravenous) brentuximab vedotin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD30-directed antibody-drug conjugate
NDA Applicant: Seagen Inc.      BLA No.: 125388  Prod. No.: 001 Rx (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
Exclusivity Type: Orphan Drug ExclusivityAug 17, 2022Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of mycosis fungoides
Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders
Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityMar 20, 2025Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Protected Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2025Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

Servier Pharmaceuticals LLC
Asparlas (Injection) (Intravenous) calaspargase pegol-mknl
Drug Classes: Antineoplastics:Antineoplastics, Other == asparagine specific enzyme
NDA Applicant: Servier Pharmaceuticals LLC      BLA No.: 761102  Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 1, 2001Orphan 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.

Servier Pharmaceuticals LLC
Oncaspar (Injection) (Intravenous, Intramuscular) pegaspargase
Drug Classes: Antineoplastics:Antineoplastics, Other == asparagine specific enzyme
NDA Applicant: Servier Pharmaceuticals LLC      BLA No.: 103411  Prod. No.: 001 Rx (3,750IU/5ML(750IU/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 1, 2001Orphan 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.

Sicor Biotech UAB
Granix (Injection) (Subcutaneous) tbo-filgrastim
NDA Applicant: Sicor Biotech UAB      BLA No.: 125294  Prod. No.: 001 Rx (300MCG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 29, 2024 

Solstice NeuroSciences, LLC
Myobloc (Injection) (Intramuscular, Intraglandular) rimabotulinumtoxinB
Drug Classes: acetylcholine release inhibitor
NDA Applicant: Solstice NeuroSciences, LLC      BLA No.: 103846  Prod. No.: 001 Rx (2,500UNITS/0.5ML); 002 Rx (5,000UNITS/ML); 003 Rx (10,000UNITS/2ML (5,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2007Orphan Designation: Treatment of cervical dystonia.
Approved Labeled Indication: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Spark Therapeutics, Inc.
Luxturna (Injection) (Intraocular) Voretigene Neparvovec
Drug Classes: adeno-associated virus vector-based gene therapy
NDA Applicant: Spark Therapeutics, Inc.      BLA No.: 125610  Prod. No.: 001 Rx (1.5X10 TO 11 ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2024Orphan Designation: Treatment of inherited retinal dystrophy due to biallelic RPE65 gene mutations
Approved Labeled Indication: an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells determined by a treating physician
Exclusivity Protected Indication: Treatment of patients with confirmed biallelic RPE65 mutation-associated retinal distrophy. Patients must have viable retinal cells determined by a treating physician.

Stemline Therapeutics Inc
Elzonris (Injection) (Intravenous) tagraxofusp-erzs
NDA Applicant: Stemline Therapeutics Inc      BLA No.: 761116  Prod. No.: 001 Rx (1,000MCG/1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm
Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
Exclusivity Protected Indication: ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.

Stratatech Corporation
StrataGraft (Cell Sheets) (Topical) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
NDA Applicant: Stratatech Corporation      BLA No.: 125730  Prod. No.: 001 Rx (100CM SQUARED)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2028Orphan Designation: Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting
Approved Labeled Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)
Exclusivity Protected Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)

Swedish Orphan Biovitrum AB (publ)
Gamifant (Injection) (Intravenous) emapalumab-lzsg
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 761107  Prod. No.: 001 Rx (10MG/2ML (5MG/ML)); 002 Rx (50MG/10ML (5MG/ML)); 003 Rx (100MG/20ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 20, 2025Orphan Designation: Treatment of hemophagocytic lymphohistiocytosis
Approved Labeled Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Exclusivity Protected Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Swedish Orphan Biovitrum AB (publ)
Kineret (Injection) (Subcutaneous) anakinra
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-1 (IL-1) receptor antagonist
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 103950  Prod. No.: 001 Rx (100MG/0.67ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2019Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID)
Exclusivity Type: Orphan Drug ExclusivityDec 18, 2027Orphan Designation: Treatment of Deficiency of IL-1 Receptor Antagonist
Approved Labeled Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Exclusivity Protected Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)



Last edited: 15 November 2022
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