DrugPatentWatch Database Preview
OCALIVA Drug Profile
When do Ocaliva patents expire, and what generic alternatives are available?
Ocaliva is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are five patents protecting this drug.
This drug has sixty-three patent family members in twenty-eight 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: | 63 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 35 |
| Patent Applications: | 43 |
| Drug Prices: | Drug price information for OCALIVA |
| DailyMed Link: | OCALIVA at DailyMed |
Generic Entry Opportunity Date for OCALIVA
Generic Entry Date for OCALIVA*:
Constraining patent/regulatory exclusivity:
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 NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free 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 OCALIVA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 104781272 | ➤ Try a Free Trial |
| Japan | 4021327 | ➤ Try a Free Trial |
| Canada | 2877122 | ➤ Try a Free Trial |
| Canada | 2983609 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for OCALIVA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2017 00025 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 0877 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: OBETICHOLZUUR; REGISTRATION NO/DATE: EU/1/16/1139 20161215 |
| 2017000034 | Germany | ➤ Try a Free Trial | PRODUCT NAME: OBETICHOLSAEURE (OBETICHOLIC ACID); REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| 90020-0 | Sweden | ➤ Try a Free Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
