Obeticholic acid - Generic Drug Details
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What are the generic sources for obeticholic acid and what is the scope of patent protection?
Obeticholic acid
is the generic ingredient in two branded drugs marketed by Apotex, Lupin Ltd, MSN, and Intercept Pharms Inc, and is included in four NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Obeticholic acid has one hundred and twenty-three patent family members in thirty-seven countries.
There is one drug master file entry for obeticholic acid. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for obeticholic acid
International Patents: | 123 |
US Patents: | 7 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 35 |
Patent Applications: | 1,151 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for obeticholic acid |
What excipients (inactive ingredients) are in obeticholic acid? | obeticholic acid excipients list |
DailyMed Link: | obeticholic acid at DailyMed |
Recent Clinical Trials for obeticholic acid
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Intercept Pharmaceuticals | Phase 2/Phase 3 |
Intercept Pharmaceuticals | N/A |
Universitaire Ziekenhuizen KU Leuven | N/A |
Generic filers with tentative approvals for OBETICHOLIC ACID
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10mg | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for obeticholic acid
Drug Class | Farnesoid X Receptor Agonist |
Mechanism of Action | Farnesoid X Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for obeticholic acid
Paragraph IV (Patent) Challenges for OBETICHOLIC ACID
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 obeticholic acid
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lupin Ltd | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214980-001 | May 30, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apotex | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214862-002 | May 30, 2023 | DISCN | No | 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 | 207999-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Msn | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 215017-002 | May 30, 2023 | DISCN | No | 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 | ⤷ 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 obeticholic acid
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 | 207999-001 | 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 |
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 obeticholic acid
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 obeticholic acid
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2016200832 | Preparation, Uses And Solid Forms Of Obeticholic Acid | ⤷ Sign Up |
Austria | 303399 | ⤷ Sign Up | |
Israel | 261372 | תכישירים, שימושים וצורות מוצקות של חומצה אובטיכולית (Preparation, uses and solid forms of obeticholic acid) | ⤷ Sign Up |
Poland | 3336097 | ⤷ Sign Up | |
Chile | 2018001720 | Formas polimórficas cristalinas del ácido obeticólico | ⤷ Sign Up |
Taiwan | 201703773 | Compositions of obeticholic acid and methods of use | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for obeticholic acid
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1392714 | 122017000034 | Germany | ⤷ Sign Up | PRODUCT NAME: OBETICHOLSAEURE; 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 |
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 | 1790020-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
1392714 | 17C0003 | France | ⤷ Sign Up | PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
1392714 | LUC00018 | Luxembourg | ⤷ Sign Up | 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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