OBETICHOLIC ACID Drug Patent Profile
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When do Obeticholic Acid patents expire, and what generic alternatives are available?
Obeticholic Acid is a drug marketed by Apotex, Lupin Ltd, and MSN. and is included in three NDAs.
The generic ingredient in OBETICHOLIC ACID 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.
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Summary for OBETICHOLIC ACID
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Clinical Trials: | 35 |
| Patent Applications: | 522 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OBETICHOLIC ACID |
| 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 |
| Universitaire Ziekenhuizen KU Leuven | N/A |
| Intercept Pharmaceuticals | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214862-001 | May 30, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214980-002 | 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 | ||||
| Lupin Ltd | OBETICHOLIC ACID | obeticholic acid | TABLET;ORAL | 214980-001 | May 30, 2023 | DISCN | No | 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 |
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 |
