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OCALIVA Drug Profile
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See Plans and PricingWhich patents cover Ocaliva, and when can generic versions of Ocaliva launch?
Ocaliva is a drug marketed by Intercept Pharms Inc and is included in one NDA. There are seven patents protecting this drug.
This drug has ninety-eight patent family members in thirty-one 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.
US ANDA Litigation and Generic Entry Outlook for Ocaliva
Ocaliva will be eligible for patent challenges on May 27, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 27, 2023. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for OCALIVA
| International Patents: | 98 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 42 |
| Patent Applications: | 58 |
| 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 |
| (3beta,5beta,6alpha,7beta)-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-[(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 |
| 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 |
| 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) |
| 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 | Start Trial | Start Trial | 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 | Y | Y | Start Trial | ||
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | RX | Yes | No | 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 OCALIVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2017002727 | Start Trial |
| Germany | 60205891 | Start Trial |
| Singapore | 10201607230S | Start Trial |
| Canada | 3047776 | Start Trial |
| El Salvador | 2017005555 | Start Trial |
| South Korea | 20180095070 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OCALIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1392714 | 1790020-0 | Sweden | Start Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | CA 2017 00025 | Denmark | Start Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | 598 | Finland | Start Trial | |
| 1392714 | CR 2017 00025 | Denmark | Start Trial | PRODUCT NAME: OBETICHOLIC ACID; REG. NO/DATE: EU/1/16/1139 20161215 |
| 1392714 | 2017/019 | Ireland | Start Trial | PRODUCT NAME: OBETICHOLIC ACID; REGISTRATION NO/DATE: EU/1/16/1139/001 EU/1/16/1139/002 20161212 |
| 1392714 | 17C0003 | France | Start Trial | PRODUCT NAME: ACIDE OBETICHOLIQUE; REGISTRATION NO/DATE: EU/1/16/1139 20161212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
