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Last Updated: November 7, 2024

ocaliva Drug Patent Profile


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When do Ocaliva patents expire, and what generic alternatives are available?

Ocaliva is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three patent family members in thirty-seven countries.

The generic ingredient in OCALIVA is obeticholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the obeticholic acid profile page.

DrugPatentWatch® Generic Entry Outlook for Ocaliva

Ocaliva was eligible for patent challenges on May 27, 2020.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (obeticholic acid), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ocaliva
Drug Prices for ocaliva

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Recent Clinical Trials for ocaliva

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 ocaliva clinical trials

Pharmacology for ocaliva
Paragraph IV (Patent) Challenges for OCALIVA
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 ocaliva

ocaliva is protected by seven US patents.

Patents protecting ocaliva

Preparation and uses of obeticholic acid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Compositions of obeticholic acid and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Preparation and uses of obeticholic acid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions of obeticholic acid and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions of obeticholic acid and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: 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

Preparation and uses of obeticholic acid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Steroids as agonists for FXR
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 ocaliva

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

EU/EMA Drug Approvals for ocaliva

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 ocaliva

When does loss-of-exclusivity occur for ocaliva?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4427
Patent: COMPOSICIONES FARMACÉUTICAS PARA TERAPIA DE COMBINACIÓN
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 16255045
Patent: Compositions of obeticholic acid and methods of use
Estimated Expiration: ⤷  Sign Up

Patent: 20205315
Patent: Compositions of obeticholic acid and methods of use
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017023161
Patent: composições de ácido obeticólico e métodos de uso
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 83609
Patent: COMPOSITIONS D'ACIDE OBETICHOLIQUE ET PROCEDES D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17002727
Patent: Composiciones de ácido obeticólico y métodos de uso
Estimated Expiration: ⤷  Sign Up

China

Patent: 7531742
Patent: 奥贝胆酸的组合物和使用方法 (Compositions of obeticholic acid and methods of use)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17011535
Patent: Composiciones de ácido obeticólico y métodos de uso
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 170492
Patent: COMPOSICIONES DE ÁCIDO OBETICÓLICO Y MÉTODOS DE USO.
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17078433
Patent: COMPOSICIONES DE ÁCIDO OBETICÓLICO Y MÉTODOS DE USO
Estimated Expiration: ⤷  Sign Up

El Salvador

Patent: 17005555
Patent: COMPOSICIONES DE ACIDO OBETICOLICO Y METODOS DE USO
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1792354
Patent: КОМПОЗИЦИИ ОБЕТИХОЛЕВОЙ КИСЛОТЫ И СПОСОБЫ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 88958
Patent: COMPOSITIONS D'ACIDE OBÉTICHOLIQUE ET PROCÉDÉS D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 71199
Patent: COMPOSITIONS D'ACIDE OBÉTICHOLIQUE ET PROCÉDÉS D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 71616
Patent: COMPOSITIONS D'ACIDE OBÉTICHOLIQUE ET PROCÉDÉS D'UTILISATION (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5269
Patent: תכשירים של חומצה אובתיקולית ושיטות לשימוש (Compositions of obeticholic acid and methods of use)
Estimated Expiration: ⤷  Sign Up

Patent: 4575
Patent: תכשירים של חומצה אובתיקולית ושיטות לשימוש (Compositions of obeticholic acid and methods of use)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 41057
Estimated Expiration: ⤷  Sign Up

Patent: 18514534
Patent: オベチコール酸の組成物および使用方法
Estimated Expiration: ⤷  Sign Up

Patent: 21183651
Patent: オベチコール酸の組成物および使用方法 (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17013805
Patent: COMPOSICIONES DE ACIDO OBETICOLICO Y METODOS DE USO. (COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 529
Patent: Compositions d'acide obeticholique et procédés d'utilisation
Estimated Expiration: ⤷  Sign Up

Patent: 999
Patent: COMPOSITIONS D'ACIDE OBÉTICHOLIQUE ET PROCÉDÉS D'UTILISATION
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1700128
Patent: COMPOSICIONES DE ACIDO OBETICOLICO Y METODOS DE USO.
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 180690
Patent: COMPOSICIONES DE ACIDO OBETICOLICO Y METODOS DE USO
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017501956
Patent: COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202003110P
Patent: COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Patent: 201708606V
Patent: COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1707981
Patent: COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 170140325
Patent: 오베티콜산의 조성물 및 사용 방법
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 23017
Estimated Expiration: ⤷  Sign Up

Patent: 1703773
Patent: Compositions of obeticholic acid and methods of use
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 17000452
Patent: COMPOSITIONS OF OBETICHOLIC ACID AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ocaliva around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1392714 STEROIDES COMME AGONISTES DE FXR (STEROIDS AS AGONISTS FOR FXR) ⤷  Sign Up
Japan 6527077 ⤷  Sign Up
Eurasian Patent Organization 201792354 КОМПОЗИЦИИ ОБЕТИХОЛЕВОЙ КИСЛОТЫ И СПОСОБЫ ПРИМЕНЕНИЯ ⤷  Sign Up
China 111228278 奥贝胆酸的制备、用途和固体形式 (Preparation, use and solid form of obeticholic acid) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ocaliva

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 LUC00018 Luxembourg ⤷  Sign Up PRODUCT NAME: ACIDE OBETICHOLIQUE ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (OCALIVA); AUTHORISATION NUMBER AND DATE: EU/1/16/1139 20161215
1392714 122017000034 Germany ⤷  Sign Up PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 2017/019 Ireland ⤷  Sign Up PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 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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