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Last Updated: February 2, 2023

Obeticholic acid - Generic Drug Details


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

Obeticholic acid is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Obeticholic acid has one hundred and twenty-four patent family members in thirty-eight countries.

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

Summary for obeticholic acid
Recent Clinical Trials for obeticholic acid

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 1
National Cancer Institute (NCI)Phase 2
Nanjing Chia-tai Tianqing PharmaceuticalPhase 3

See all obeticholic acid clinical trials

Generic filers with tentative approvals for OBETICHOLIC ACID
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing10mgTABLET; ORAL
See Plans and PricingSee Plans and Pricing10mgTABLET; ORAL
See Plans and PricingSee Plans and Pricing10MGTABLET; 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
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 207999-002 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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
Israel 236231 See Plans and Pricing
Israel 157816 BILE ACIDS AND THEIR CONJUGATES WITH AMINO ACIDS AS AGONISTS FOR FXR See Plans and Pricing
Chile 2018001720 Formas polimórficas cristalinas del ácido obeticólico See Plans and Pricing
Argentina 104427 COMPOSICIONES FARMACÉUTICAS PARA TERAPIA DE COMBINACIÓN See Plans and Pricing
Canada 2983609 COMPOSITIONS D'ACIDE OBETICHOLIQUE ET PROCEDES D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for obeticholic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 C01392714/01 Switzerland See Plans and Pricing PRODUCT NAME: ACIDUM OBETICHOLICUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66530 01.06.2018
1392714 132017000061826 Italy See Plans and Pricing PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215
1392714 300877 Netherlands See Plans and Pricing PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215
1392714 LUC00018 Luxembourg See Plans and Pricing PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714 23/2017 Austria See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Express Scripts
McKesson
Moodys
McKinsey

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