Details for New Drug Application (NDA): 207999
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NDA 207999 describes OCALIVA, which is a drug marketed by Intercept Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the OCALIVA profile page.
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.
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 207999
| Tradename: | OCALIVA |
| Applicant: | Intercept Pharms Inc |
| Ingredient: | obeticholic acid |
| Patents: | 7 |
Pharmacology for NDA: 207999
| Mechanism of Action | Farnesoid X Receptor Agonists |
Suppliers and Packaging for NDA: 207999
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCALIVA | obeticholic acid | TABLET;ORAL | 207999 | NDA | Intercept Pharmaceuticals Inc | 69516-005 | 69516-005-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-005-30) |
| OCALIVA | obeticholic acid | TABLET;ORAL | 207999 | NDA | Intercept Pharmaceuticals Inc | 69516-010 | 69516-010-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-010-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 27, 2016 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 27, 2023 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 26, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 207999
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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