Tradenames starting with "F"

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


Fabrazyme (For Injection) (Intravenous) agalsidase beta
NDA Applicant: Genzyme Corporation      BLA No.: 103979  Prod. No.: 001 Rx (35MG); 002 Rx (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 24, 2010Orphan Designation: Treatment of Fabry's disease.
Approved Labeled Indication: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
Exclusivity Type: Orphan Drug ExclusivityMar 11, 2028Orphan Designation: Treatment of Fabry's disease.
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease
Exclusivity Protected Indication: treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease

Flublok (Injection) (Intramuscular) Influenza Vaccine
NDA Applicant: Protein Sciences Corporation      BLA No.: 125285  Prod. No.: 002 Rx (180UG/.5ML) BLA No.: 125285  Prod. No.: 001 Disc (135UG/.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJan 16, 2025 



Last edited: 19 August 2023
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