DrugPatentWatch Database Preview
OCALIVA Drug Profile
Which patents cover Ocaliva, and when can generic versions of Ocaliva launch?
This drug has forty-four patent family members in twenty-four 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.
Summary for OCALIVA
| International Patents: | 44 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 33 |
| Patent Applications: | 41 |
| Drug Prices: | see details |
| DailyMed Link: | OCALIVA at DailyMed |
Pharmacology for OCALIVA
| Drug Class | Farnesoid X Receptor Agonist |
| Mechanism of Action | Farnesoid X Receptor Agonists |
Synonyms for OCALIVA
| (3alpha,5beta,6alpha,7alpha,8xi)-6-Ethyl-3,7-dihydroxycholan-24-oic acid |
| (3alpha,5beta,6alpha,7alpha)-6-Ethyl-3,7-dihydroxycholan-24-oic acid |
| (4R)-4-[(1S,2S,5R,7S,8R,9R,10S,11S,14R,15R)-8-ethyl-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic acid |
| (4R)-4-[(1S,2S,5R,7S,8R,9R,10S,11S,14R,15R)-8-ETHYL-5,9-DIHYDROXY-2,15-DIMETHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECAN-14-YL]PENTANOIC ACID |
| (4R)-4-[(3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid |
| (R)-4-((3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid |
| (R)-4-((3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid |
| 0462Z4S4OZ |
| 1osv |
| 3alpha,7alpha-dihydroxy-6alpha-ethyl-5beta-cholan-24-oic acid |
| 459789-99-2 |
| 6-ECDCA |
| 6-Et CDCA |
| 6-Ethyl-CDCA |
| 6-ETHYL-CHENODEOXYCHOLIC ACID |
| 6-ETHYL-ISO-URSODEOXYCHOLIC ACID |
| 6-Ethylchenodeoxycholic acid |
| 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic acid |
| 6alpha-Ethyl-chenodeoxycholic acid |
| 6alpha-ethylchenodeoxycholic acid |
| 6ECDCA |
| AC1L9L5G |
| AK-78140 |
| AKOS024259126 |
| AN-28276 |
| BDBM21675 |
| C15636 |
| CHEBI:43602 |
| CHEMBL566315 |
| Cholan-24-oic acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)- |
| CS-3813 |
| CTK8E7311 |
| D09360 |
| D0M4WA |
| DB05990 |
| DSP-1747 |
| DTXSID20196671 |
| EX-A387 |
| GS-6103 |
| GTPL3435 |
| HY-12222 |
| INT 747 |
| INT-747 |
| INT747 |
| IU6 |
| MolPort-035-682-579 |
| Obeticholic acid |
| Obeticholic acid (JAN/USAN/INN) |
| Obeticholic acid [USAN:INN] |
| Ocaliva (TN) |
| PL008513 |
| RT-010630 |
| SCHEMBL715823 |
| UNII-0462Z4S4OZ |
| Y1328 |
| ZINC14164617 |
| ZXERDUOLZKYMJM-ZWECCWDJSA-N |
US Patents and Regulatory Information for OCALIVA
| 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 | 207999-002 | May 27, 2016 | RX | Yes | Yes | ➤ 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 | 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 | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Non-Orange Book US Patents for OCALIVA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,732,117 | Steroids as agonists for FXR | ➤ Sign Up |
| 7,786,102 | Steroids as agonists for FXR | ➤ Sign Up |
| 9,732,116 | Preparation and uses of obeticholic acid | ➤ Sign Up |
| 8,969,330 | Steroids as agonists for FXR | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for OCALIVA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 02072598 | ➤ Sign Up |
| Spain | 2248581 | ➤ Sign Up |
| Chile | 2014003475 | ➤ Sign Up |
| Japan | 2007269815 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for OCALIVA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0877 | Netherlands | ➤ Sign Up | PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215 |
| /2017 | Austria | ➤ Sign Up | PRODUCT NAME: OBETICHOLSAEURE, DESSEN PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE ODER AMINOSAEURE-KONJUGATE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| 2017000034 | Germany | ➤ Sign Up | PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| 2017 00025 | Denmark | ➤ Sign Up | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
