CliffBio
small molecule

OPSYNVI

MACITENTAN; TADALAFIL

Loss of exclusivitySeptember 2031FDA regulatory exclusivity expiry
CompanyActelion →View the full company profile on CliffBio

Drug detail

Brand nameOPSYNVI
Active ingredientMACITENTAN; TADALAFIL
Strength10MG;40MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2024
Marketing statusRX

Listed patents

PatentExpiresType
8268847*PEDOctober 2029—
8268847April 2029product
10946015*PEDMarch 2027—
10946015September 2026product
7094781*PEDJune 2026—
7094781December 2025substance, product

Regulatory exclusivity

CodeExpires
PEDSeptember 2031
ODE-475March 2031
PEDSeptember 2027
NPMarch 2027

More from Actelion

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

OPSYNVI patent cliff — loss of exclusivity September 2031 | CliffBio