Company names starting with "W"

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.

Wellcome Foundation Limited Wellcome Research Laboratories
Digibind (For Injection) (Intravenous) Digoxin Immune Fab (Ovine)
NDA Applicant: Wellcome Foundation Limited Wellcome Research Laboratories      BLA No.: 103141  Prod. No.: 001 Disc (38MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 22, 1993Orphan Designation: Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy.

Wyeth Pharmaceuticals Inc.
Neumega (For Injection) (Subcutaneous) oprelvekin
NDA Applicant: Wyeth Pharmaceuticals Inc.      BLA No.: 103694  Prod. No.: 001 Disc (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2004Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.

Wyeth Pharmaceuticals LLC
Benefix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 103677  Prod. No.: 001 Rx (1000IU/ML); 002 Rx (500IU/ML); 003 Rx (250IU/ML); 004 Rx (2000IU/ML); 005 Rx (3000IU/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 11, 2004Orphan Designation: Treatment of hemophilia B
Approved Labeled Indication: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings.

Wyeth Pharmaceuticals LLC
Besponsa (For Injection) (Intravenous) inotuzumab ozogamicin
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 761040  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 17, 2024Orphan Designation: Treatment of B-cell acute lymphoblastic leukemia
Approved Labeled Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Exclusivity Protected Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Wyeth Pharmaceuticals LLC
Mylotarg (For Injection) (Intravenous) gemtuzumab ozogamicin
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 761060  Prod. No.: 001 Rx (4.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2007Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
Exclusivity Type: Orphan Drug ExclusivitySep 1, 2024Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Protected Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Type: Orphan Drug ExclusivityJun 16, 2027Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Mylotarg is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.
Exclusivity Protected Indication: For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older

Wyeth Pharmaceuticals LLC
Prevnar 20 (Injection) (Intramuscular) 20-valent Pneumococcal Conjugate Vaccine
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 125731  Prod. No.: 001 Rx (0.5 ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJun 8, 2033 

Wyeth Pharmaceuticals LLC
Trumenba (Injection) (Intramuscular) Meningococcal Group B Vaccine
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 125549  Prod. No.: 001 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityOct 29, 2026 


Last edited: 19 August 2023
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