OCALIVA Drug Patent Profile
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Which patents cover Ocaliva, 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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Summary for OCALIVA
| International Patents: | 123 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 4 |
| Patent Applications: | 522 |
| 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 |
|---|---|
| Intercept Pharmaceuticals | N/A |
| Universitaire Ziekenhuizen KU Leuven | 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 |
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
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Preparation and uses of obeticholic acid
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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
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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 | |||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
| 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 |
| >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 |
| Canada | 3047776 | PREPARATION, UTILISATIONS ET FORMES SOLIDES D'ACIDE OBETICHOLIQUE (PREPARATION, USES AND SOLID FORMS OF OBETICHOLIC ACID) | ⤷ Sign Up |
| Chile | 2017002727 | Composiciones de ácido obeticólico y métodos de uso | ⤷ Sign Up |
| Japan | 2015521621 | オベチコール酸の調製、使用および固体形態 | ⤷ 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 |
| 1392714 | 132017000061826 | Italy | ⤷ Sign Up | PRODUCT NAME: ACIDO OBETICOLICO(OCALIVA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1139, 20161215 |
| 1392714 | 17C0003 | France | ⤷ Sign Up | PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| 1392714 | CA 2017 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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