small molecule

REVATIO

SILDENAFIL CITRATE

Loss of exclusivityJanuary 2026FDA regulatory exclusivity expiry
CompanyVIATRIS SPECIALTY LLC

Drug detail

Brand nameREVATIO
Active ingredientSILDENAFIL CITRATE
StrengthEQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalNovember 2009
Marketing statusRX

Regulatory exclusivity

CodeExpires
M-287January 2026

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

REVATIO patent cliff — loss of exclusivity January 2026 | CliffBio