Last Updated: November 1, 2026

Details for Patent: 10,758,549


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Which drugs does patent 10,758,549 protect, and when does it expire?

Patent 10,758,549 protects OCALIVA and is included in one NDA.

This patent has thirty-four patent family members in twenty-five countries.

Summary for Patent: 10,758,549
Title:Compositions of obeticholic acid and methods of use
Abstract:The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.
Inventor(s):Richard Gail Lancaster, Kay K. Olmstead, Masashi Kagihiro, Mitsuhiro Matono, Ikuko Taoka, Mark Pruzanski, David Shapiro, Roya Hooshmand-Rad, Richard Pencek, Cathi Sciacca, Lise Eliot, Jeffrey Edwards, Leigh A. MacConell, Tonya K. Marmon
Assignee: Intercept Pharmaceuticals Inc
Application Number:US16/787,796
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,758,549
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;

Drugs Protected by US Patent 10,758,549

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 DISCN Yes No 10,758,549 ⤷  Start Trial TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA ⤷  Start Trial
Intercept OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 DISCN Yes No 10,758,549 ⤷  Start Trial TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,758,549

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 104427 ⤷  Start Trial
Australia 2016255045 ⤷  Start Trial
Australia 2020205315 ⤷  Start Trial
Brazil 112017023161 ⤷  Start Trial
Canada 2983609 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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