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-two 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
Summary for OCALIVA
International Patents: | 122 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 4 |
Patent Applications: | 670 |
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 |


Recent Clinical Trials for OCALIVA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Universitaire Ziekenhuizen KU Leuven | N/A |
Intercept Pharmaceuticals | N/A |
M.D. Anderson Cancer Center | Phase 1 |
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 seven US patents and one FDA Regulatory Exclusivity.
Patents protecting OCALIVA
Preparation and uses of obeticholic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Compositions of obeticholic acid and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Preparation and uses of obeticholic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions of obeticholic acid and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions of obeticholic acid and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Steroids as agonists for FXR
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 16255045
Estimated Expiration: ⤷ Try a Trial
Patent: 20205315
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017023161
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 83609
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17002727
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7531742
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17011535
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 170492
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17078433
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 17005555
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1792354
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 88958
Estimated Expiration: ⤷ Try a Trial
Patent: 71199
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5269
Estimated Expiration: ⤷ Try a Trial
Patent: 4575
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 41057
Estimated Expiration: ⤷ Try a Trial
Patent: 18514534
Estimated Expiration: ⤷ Try a Trial
Patent: 21183651
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17013805
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 529
Estimated Expiration: ⤷ Try a Trial
Patent: 999
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1700128
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 180690
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 017501956
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202003110P
Estimated Expiration: ⤷ Try a Trial
Patent: 201708606V
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1707981
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 170140325
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 23017
Estimated Expiration: ⤷ Try a Trial
Patent: 1703773
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 17000452
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Taiwan | I673284 | ⤷ Try a Trial | |
Japan | 6527077 | ⤷ Try a Trial | |
Japan | 6877389 | ⤷ Try a Trial | |
Japan | 2020125317 | オベチコール酸の調製、使用および固体形態 (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OCALIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1392714 | C01392714/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ACIDUM OBETICHOLICUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66530 01.06.2018 |
1392714 | 2017/019 | Ireland | ⤷ Try a Trial | PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212 |
1392714 | 132017000061826 | Italy | ⤷ Try a Trial | PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215 |
1392714 | LUC00018 | Luxembourg | ⤷ Try a Trial | 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 |