drug · small molecule
odevixibat
Marketedupdated 3mo agoby Ipsen SA🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 6 investigational indications.
targets
Ileal sodium/bile acid cotransporter
all catalysts(6)
approval · 6
Jul 20, 2021
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
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Oct 21, 2022
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
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May 8, 2023
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
Jun 13, 2023
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
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Mar 20, 2025
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
Dec 19, 2025
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
Trials studying odevixibat
- phase3Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
- phase3Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
- phase3An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
- phase3Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
- phase3This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
- —Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
- phase3Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jul 20, 2028
~1.9 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (64)
- Nov 12, 2041method-of-use (U-3186)US 11583539
- Nov 12, 2041method-of-use (U-3186)US 11583539
- Nov 12, 2041method-of-use (U-3186)US 11583539
- Nov 12, 2041method-of-use (U-3186)US 11583539
- Nov 12, 2041method-of-use (U-3186)US 12447156
- Nov 12, 2041method-of-use (U-3186)US 12447156
- Nov 12, 2041method-of-use (U-3186)US 12447156
- Nov 12, 2041method-of-use (U-3186)US 12447156
- Jun 20, 2039compositionUS 10975046
- Jun 20, 2039compositionUS 10975046
- Jun 20, 2039compositionUS 10975046
- Jun 20, 2039compositionUS 10975046
- Jun 20, 2039method-of-use (U-3186)US 11365182
- Jun 20, 2039method-of-use (U-3186)US 11365182
- Jun 20, 2039method-of-use (U-3186)US 11365182
- Jun 20, 2039method-of-use (U-3186)US 11365182
- Jun 20, 2039formulationUS 11801226
- Jun 20, 2039formulationUS 11801226
- Jun 20, 2039formulationUS 11801226
- Jun 20, 2039formulationUS 11801226
- Jun 20, 2039formulationUS 11802115
- Jun 20, 2039formulationUS 11802115
- Jun 20, 2039formulationUS 11802115
- Jun 20, 2039formulationUS 11802115
- Jun 20, 2039compositionUS 12091394
- Jun 20, 2039compositionUS 12091394
- Jun 20, 2039compositionUS 12091394
- Jun 20, 2039compositionUS 12091394
- Jun 20, 2039method-of-use (U-3186)US 12508234
- Jun 20, 2039method-of-use (U-3186)US 12508234
- Jun 20, 2039method-of-use (U-3186)US 12508234
- Jun 20, 2039method-of-use (U-3648)US 12508234
- Nov 8, 2031method-of-use (U-3648)US 10011633
- Nov 8, 2031method-of-use (U-3648)US 10011633
- Nov 8, 2031method-of-use (U-3648)US 10011633
- Nov 8, 2031method-of-use (U-3648)US 10011633
- Nov 8, 2031method-of-use (U-3648)US 10093697
- Nov 8, 2031method-of-use (U-3648)US 10093697
- Nov 8, 2031method-of-use (U-3648)US 10093697
- Nov 8, 2031method-of-use (U-3648)US 10093697
- Nov 8, 2031method-of-use (U-3648)US 10487111
- Nov 8, 2031method-of-use (U-3648)US 10487111
- Nov 8, 2031method-of-use (U-3648)US 10487111
- Nov 8, 2031method-of-use (U-3648)US 10487111
- Nov 8, 2031method-of-use (U-3649)US 10981952
- Nov 8, 2031method-of-use (U-3648)US 10981952
- Nov 8, 2031method-of-use (U-3649)US 10981952
- Nov 8, 2031method-of-use (U-3649)US 10981952
- Nov 8, 2031method-of-use (U-3186)US 11732006
- Nov 8, 2031method-of-use (U-3186)US 11732006
- Nov 8, 2031method-of-use (U-3186)US 11732006
- Nov 8, 2031method-of-use (U-3186)US 11732006
- Nov 8, 2031method-of-use (U-3648)US 12187812
- Nov 8, 2031method-of-use (U-3648)US 12187812
- Nov 8, 2031method-of-use (U-3648)US 12187812
- Nov 8, 2031method-of-use (U-3648)US 12187812
- Nov 8, 2031method-of-use (U-3648)US 12545705
- Nov 8, 2031method-of-use (U-3648)US 12545705
- Nov 8, 2031method-of-use (U-3648)US 12545705
- Nov 8, 2031method-of-use (U-3648)US 12545705
- Nov 8, 2031method-of-use (U-3648)US 9694018
- Nov 8, 2031method-of-use (U-3648)US 9694018
- Nov 8, 2031method-of-use (U-3648)US 9694018
- Nov 8, 2031method-of-use (U-3648)US 9694018
FDA exclusivities (16)
- Jun 13, 2030ODE-436Orphan Drug (7y)3.8y
- Jun 13, 2030ODE-436Orphan Drug (7y)3.8y
- Jun 13, 2030ODE-436Orphan Drug (7y)3.8y
- Jun 13, 2030ODE-436Orphan Drug (7y)3.8y
- Jul 20, 2028ODE-363Orphan Drug (7y)1.9y
- Jul 20, 2028ODE-363Orphan Drug (7y)1.9y
- Jul 20, 2028ODE-363Orphan Drug (7y)1.9y
- Jul 20, 2028ODE-363Orphan Drug (7y)1.9y
- Jul 20, 2026NCENew Chemical Entity (5y)
- Jul 20, 2026NCENew Chemical Entity (5y)
- Jul 20, 2026NCENew Chemical Entity (5y)
- Jul 20, 2026NCENew Chemical Entity (5y)
- Jun 13, 2026I-918Indication (3y)
- Jun 13, 2026I-918Indication (3y)
- Jun 13, 2026I-918Indication (3y)
- Jun 13, 2026I-918Indication (3y)
News(2)
- Regeneron wins FDA approval to challenge Ipsen for rare bone disease marketRegeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.biospace · 18h ago
- Ipsen’s Bylvay fails key trial in children with rare liver diseaseIpsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proced…endpoints · 27d ago
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