Odevixibat Patent Expiration

Odevixibat is used for reducing serum bile acids and treating pruritus in patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis. It was first introduced by Ipsen Biopharmaceuticals Inc in its drug Bylvay on Jul 20, 2021.


Odevixibat Patents

Given below is the list of patents protecting Odevixibat, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Bylvay US11583539 Treating progressive familial intrahepatic cholestasis (PFIC) with IBAT inhibitors Nov 12, 2041 Ipsen
Bylvay US12447156 Treating Progressive Familial Intrahepatic Cholestasis (Pfic) With Ibat Inhibitors Nov 12, 2041 Ipsen
Bylvay US10975046 Crystal modifications of odevixibat Jun 20, 2039 Ipsen
Bylvay US11365182 Crystal modifications of odevixibat Jun 20, 2039 Ipsen
Bylvay US11801226 Pharmaceutical formulation of odevixibat Jun 20, 2039 Ipsen
Bylvay US11802115 Pharmaceutical formulation of odevixibat Jun 20, 2039 Ipsen
Bylvay US12091394 Crystal modifications of odevixibat Jun 20, 2039 Ipsen
Bylvay US12508234 Pharmaceutical Formulation Of Odevixibat Jun 20, 2039 Ipsen
Bylvay US9694018 IBAT inhibitors for the treatment of liver disease Mar 18, 2034 Ipsen
Bylvay US10011633 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US10093697 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US10487111 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US10981952 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US11732006 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US12187812 IBAT inhibitors for the treatment of liver diseases Nov 08, 2031 Ipsen
Bylvay US12545705 Ibat Inhibitors For The Treatment Of Liver Diseases Nov 08, 2031 Ipsen
Bylvay US7132416 Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia Sep 05, 2022

(Expired)

Ipsen



Odevixibat's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Odevixibat:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome Albireo, an Ipsen Company NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia Albireo, an Ipsen Company NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD) Albireo, an Ipsen Company NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3


Odevixibat Generic API Manufacturers

Given below is the list of companies who have filed for Odevixibat generic, along with the locations of their manufacturing plants worldwide.