small molecule

FIRDAPSE

AMIFAMPRIDINE PHOSPHATE

Loss of exclusivityFebruary 2037latest FDA-listed patent expiry
CompanyCatalyst

Drug detail

Brand nameFIRDAPSE
Active ingredientAMIFAMPRIDINE PHOSPHATE
StrengthEQ 10MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2018
Marketing statusRX

Listed patents

PatentExpiresType
10626088February 2037product
10793893May 2034use U-2956
11274332June 2032use U-2956
11274331June 2032use U-2956
11268128June 2032use U-2956
11060128June 2032use U-2956

Regulatory exclusivity

CodeExpires
ODE-553September 2029

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

FIRDAPSE patent cliff — loss of exclusivity February 2037 | CliffBio