small molecule

FILSPARI

SPARSENTAN

Loss of exclusivitySeptember 2031FDA regulatory exclusivity expiry
CompanyTravere TherapeuticsSee this company's full patent-cliff portfolio

Drug detail

Brand nameFILSPARI
Active ingredientSPARSENTAN
Strength200MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2023
Marketing statusRX

Listed patents

PatentExpiresType
9993461March 2030use U-4495
9662312March 2030use U-4495

Regulatory exclusivity

CodeExpires
ODE-493September 2031
ODE-389February 2030
I-989April 2029
NCEFebruary 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

FILSPARI patent cliff — loss of exclusivity September 2031 | CliffBio