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Last Updated: June 13, 2024

Obeticholic acid - Generic Drug Details


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What are the generic sources for obeticholic acid and what is the scope of patent protection?

Obeticholic acid is the generic ingredient in two branded drugs marketed by Apotex, Lupin Ltd, MSN, and Intercept Pharms Inc, and is included in four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Obeticholic acid has one hundred and twenty-two patent family members in thirty-seven countries.

There is one drug master file entry for obeticholic acid. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for obeticholic acid
Recent Clinical Trials for obeticholic acid

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Intercept PharmaceuticalsN/A
Universitaire Ziekenhuizen KU LeuvenN/A
M.D. Anderson Cancer CenterPhase 1

See all obeticholic acid clinical trials

Generic filers with tentative approvals for OBETICHOLIC ACID
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10mgTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for obeticholic acid
Anatomical Therapeutic Chemical (ATC) Classes for obeticholic acid
Paragraph IV (Patent) Challenges for OBETICHOLIC ACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OCALIVA Tablets obeticholic acid 5 mg and 10 mg 207999 5 2020-05-27

US Patents and Regulatory Information for obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Lupin Ltd OBETICHOLIC ACID obeticholic acid TABLET;ORAL 214980-001 May 30, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn OBETICHOLIC ACID obeticholic acid TABLET;ORAL 215017-001 May 30, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for obeticholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for obeticholic acid

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
ADVANZ PHARMA Limited Ocaliva obeticholic acid EMEA/H/C/004093
Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Authorised no no yes 2016-12-12
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for obeticholic acid

Country Patent Number Title Estimated Expiration
Mexico 2019005819 PREPARACION Y USOS DE ACIDO OBETICOLICO. (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID.) ⤷  Sign Up
Japan 6527077 ⤷  Sign Up
European Patent Office 3336097 PRÉPARATION DE LA FORME NON-CRYSTALLINE D'ACIDE OBETICHOLIQUE (PREPARATION OF THE NON-CRYSTALLINE FORM OF OBETICHOLIC ACID) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for obeticholic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 598 Finland ⤷  Sign Up
1392714 122017000034 Germany ⤷  Sign Up PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 23/2017 Austria ⤷  Sign Up PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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