← Patent-cliff monitor small molecule OTEZLA APREMILAST
Loss of exclusivity November 2034 latest FDA-listed patent expiry
Company Amgen → View the full company profile on CliffBio Drug detail Brand name OTEZLA Active ingredient APREMILAST Strength 30MG Dosage form TABLET Route ORAL Modality Small molecule FDA approval March 2014 Marketing status RX
Listed patents Patent Expires Type 10092541*PED November 2034 — 9872854*PED November 2034 — 12576034*PED May 2034 — 9872854 May 2034 use U-2233 10092541 May 2034 use U-2659 12576034 November 2033 product 7427638*PED August 2028 — 7427638 February 2028 substance, product
Regulatory exclusivity Code Expires PED October 2027 NPP April 2027 PED January 2027 PED January 2027 M-299 July 2026 ODE-248 July 2026
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.