← Patent-cliff monitor small molecule SEPHIENCE SEPIAPTERIN
Loss of exclusivity March 2042 latest FDA-listed patent expiry
Drug detail Brand name SEPHIENCE Active ingredient SEPIAPTERIN Strength 250MG/PACKET Dosage form POWDER Route ORAL Modality Small molecule FDA approval July 2025 Marketing status RX
Listed patents Patent Expires Type 12257252 March 2042 use U-4250 12213982 September 2038 use U-4251 11752154 September 2038 product 11072614 April 2038 substance
Regulatory exclusivity Code Expires ODE-542 July 2032 NCE July 2030
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.