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
Summary for OCALIVA
International Patents: | 123 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 3 |
Patent Applications: | 824 |
Drug Prices: | Drug price information for OCALIVA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OCALIVA |
What excipients (inactive ingredients) are in OCALIVA? | OCALIVA excipients list |
DailyMed Link: | OCALIVA at DailyMed |


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
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 1 |
National Cancer Institute (NCI) | Phase 2 |
Pharmacology for OCALIVA
Drug Class | Farnesoid X Receptor Agonist |
Mechanism of Action | Farnesoid X Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |