← Patent-cliff monitor small molecule OTEZLA XR APREMILAST
Loss of exclusivity May 2042 latest FDA-listed patent expiry
Company Amgen → See this company's full patent-cliff portfolio Drug detail Brand name OTEZLA XR Active ingredient APREMILAST Strength 75MG Dosage form TABLET, EXTENDED RELEASE Route ORAL Modality Small molecule FDA approval August 2025 Marketing status RX
Listed patents Patent Expires Type 11752129 May 2042 product 12427136 May 2042 use U-4291 11969409 May 2042 product 10092541 May 2034 use U-2659 7427638 February 2028 substance, product
Regulatory exclusivity Code Expires PED January 2027 PED January 2027 M-299 July 2026 ODE* 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.