small molecule

MACITENTAN

MACITENTAN

Loss of exclusivityDecember 2026FDA regulatory exclusivity expiry
CompanyZYDUS LIFESCIENCES GLOBAL FZE

Drug detail

Brand nameMACITENTAN
Active ingredientMACITENTAN
Strength10MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalApril 2021
Marketing statusRX

Regulatory exclusivity

CodeExpires
PCDecember 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.

MACITENTAN patent cliff — loss of exclusivity December 2026 | CliffBio