Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Apr 24, 2010 | Orphan 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 Exclusivity | Mar 11, 2028 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Ref. Product Exclusivity | Jan 16, 2025 |