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
→
Oct 21, 2022
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
May 8, 2023
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
Jun 13, 2023
approval
BYLVAY (ODEVIXIBAT) — FDA approval
odevixibat
→
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(1)
- 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 · 24d ago
Data sources
last refreshed 7m ago
Found something off?
comments(0)
5-min edit window · permanent after that