small molecule

OPSUMIT

MACITENTAN

Loss of exclusivityOctober 2029latest FDA-listed patent expiry
CompanyActelionView the full company profile on CliffBio

Drug detail

Brand nameOPSUMIT
Active ingredientMACITENTAN
Strength10MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2013
Marketing statusRX

Listed patents

PatentExpiresType
8268847*PEDOctober 2029
8268847April 2029use U-1446
8367685*PEDApril 2029
8367685October 2028product
9265762*PEDNovember 2027
9265762May 2027product
10946015*PEDMarch 2027
10946015September 2026product
7094781*PEDJune 2026
7094781December 2025substance, product

Regulatory exclusivity

CodeExpires
PEDAugust 2028
M-187February 2028

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.

OPSUMIT patent cliff — loss of exclusivity October 2029 | CliffBio