← Patent-cliff monitor small molecule KOSELUGO SELUMETINIB SULFATE
Loss of exclusivity November 2032 FDA regulatory exclusivity expiry
Company ASTRAZENECA PHARMACEUTICALS LP
Drug detail Brand name KOSELUGO Active ingredient SELUMETINIB SULFATE Strength EQ 10MG BASE Dosage form CAPSULE Route ORAL Modality Small molecule FDA approval April 2020 Marketing status RX
Listed patents Patent Expires Type 12364684 March 2029 use U-4357 12220403 March 2029 product 11813246 March 2029 product 12318367 March 2029 product 7425637 March 2028 substance 9156795 December 2026 substance, product 9562017 December 2026 substance 8178693 March 2026 substance, product
Regulatory exclusivity Code Expires ODE-545 November 2032 NPP November 2028 NPP September 2028 ODE-288 April 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.