← Patent-cliff monitor small molecule BYLVAY ODEVIXIBAT
Loss of exclusivity November 2041 latest FDA-listed patent expiry
Company IPSEN BIOPHARMACEUTICALS INC
Drug detail Brand name BYLVAY Active ingredient ODEVIXIBAT Strength 0.2MG Dosage form CAPSULE, PELLETS Route ORAL Modality Small molecule FDA approval July 2021 Marketing status RX
Listed patents Patent Expires Type 11583539 November 2041 use U-3186 12447156 November 2041 use U-3186 10975046 June 2039 substance 12508234 June 2039 use U-3648 11365182 June 2039 use U-3186 11801226 June 2039 product 12091394 June 2039 substance 11802115 June 2039 product 9694018 March 2034 use U-3648 11732006 November 2031 use U-3186 12187812 November 2031 use U-3648 12545705 November 2031 use U-3648 10011633 November 2031 use U-3648 10093697 November 2031 use U-3648 10487111 November 2031 use U-3648 10981952 November 2031 use U-3649
Regulatory exclusivity Code Expires ODE-436 June 2030 ODE-363 July 2028 NCE July 2026 I-918 June 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.