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Obeticholic acid - Generic Drug Details
What are the generic sources for obeticholic acid and what is the scope of patent protection?
Obeticholic acid
is the generic ingredient in one branded drug marketed by Intercept Pharms Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Obeticholic acid has one hundred and four patent family members in thirty-three countries.
There is one drug master file entry for obeticholic acid. One supplier is listed for this compound.
Summary for obeticholic acid
| International Patents: | 104 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 42 |
| Clinical Trials: | 20 |
| Patent Applications: | 67 |
| DailyMed Link: | obeticholic acid at DailyMed |
Recent Clinical Trials for obeticholic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 1 |
| Sir Salimullah Medical College Mitford Hospital | N/A |
| Intercept Pharmaceuticals | Phase 4 |
Pharmacology for obeticholic acid
| Drug Class | Farnesoid X Receptor Agonist |
| Mechanism of Action | Farnesoid X Receptor Agonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for obeticholic acid
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 107531742 | Start Trial |
| Japan | 2018538331 | Start Trial |
| Germany | 60205891 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for obeticholic acid
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1392714 | 300877 | Netherlands | Start Trial | PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | 1790020-0 | Sweden | Start Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | 122017000034 | Germany | Start Trial | PRODUCT NAME: OBETICHOLSAEURE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| >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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