← Patent-cliff monitor small molecule OPSYNVI MACITENTAN; TADALAFIL
Loss of exclusivity September 2031 FDA regulatory exclusivity expiry
Company Actelion → See this company's full patent-cliff portfolio Drug detail Brand name OPSYNVI Active ingredient MACITENTAN; TADALAFIL Strength 10MG;20MG Dosage form TABLET Route ORAL Modality Small molecule FDA approval March 2024 Marketing status RX
Listed patents Patent Expires Type 8268847*PED October 2029 — 8268847 April 2029 product 10946015*PED March 2027 — 10946015 September 2026 product 7094781*PED June 2026 — 7094781 December 2025 substance, product
Regulatory exclusivity Code Expires PED September 2031 ODE-475 March 2031 PED September 2027 NP March 2027
Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.