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Last Updated: June 28, 2022

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 ten patents protecting this drug and one Paragraph IV challenge.

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 26, 2036. This may change due to patent challenges or generic licensing.

There have been seven 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

See drug prices for OCALIVA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for OCALIVA
Generic Entry Date for OCALIVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OCALIVA

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 1
National Cancer Institute (NCI)Phase 2

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 ten US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OCALIVA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting OCALIVA

Preparation and uses of obeticholic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Compositions of obeticholic acid and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Preparation and uses of obeticholic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions of obeticholic acid and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions of obeticholic acid and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Steroids as agonists for FXR
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Steroids as agonists for FXR
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Steroids as agonists for FXR
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)

Preparation and uses of obeticholic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Steroids as agonists for FXR
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting OCALIVA

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
Exclusivity Expiration: 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
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
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 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
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
>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 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 See Plans and Pricing See Plans and Pricing
>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
Intercept Pharma International Ltd 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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 16255045
Estimated Expiration: See Plans and Pricing

Patent: 20205315
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017023161
Estimated Expiration: See Plans and Pricing

Canada

Patent: 83609
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17002727
Estimated Expiration: See Plans and Pricing

China

Patent: 7531742
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17011535
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170492
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17078433
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 17005555
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1792354
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 88958
Estimated Expiration: See Plans and Pricing

Patent: 71199
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5269
Estimated Expiration: See Plans and Pricing

Japan

Patent: 41057
Estimated Expiration: See Plans and Pricing

Patent: 18514534
Estimated Expiration: See Plans and Pricing

Patent: 21183651
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17013805
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 529
Estimated Expiration: See Plans and Pricing

Patent: 999
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1700128
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180690
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017501956
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202003110P
Estimated Expiration: See Plans and Pricing

Patent: 201708606V
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1707981
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170140325
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 23017
Estimated Expiration: See Plans and Pricing

Patent: 1703773
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000452
Estimated Expiration: See Plans and Pricing

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
Australia 2016255045 Compositions of obeticholic acid and methods of use See Plans and Pricing
Norway 326134 See Plans and Pricing
Denmark 1392714 See Plans and Pricing
European Patent Office 3394081 FORMES CRISTALLINES POLYMORPHES DE L'ACIDE OBÉTICHOLIQUE (POLYMORPHIC CRYSTALLINE FORMS OF OBETICHOLIC ACID) See Plans and Pricing
China 108495858 奥贝胆酸的多晶结晶形式 (POLYMORPHIC CRYSTALLINE FORMS OF OBETICHOLIC ACID) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OCALIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1392714 17C0003 France See Plans and Pricing PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 122017000034 Germany See Plans and Pricing PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212
1392714 CR 2017 00025 Denmark See Plans and Pricing PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215
1392714 CA 2017 00025 Denmark See Plans and Pricing PRODUCT NAME: OBETICHOLIC ACID; REG. 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Colorcon
AstraZeneca
McKesson
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.