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Details for New Drug Application (NDA): 207999
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 |
Generic Entry Opportunity Date for 207999
Generic Entry Date for 207999*:
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 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 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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 27, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| 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: | Start Trial | Patent Expiration: | Sep 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) | ||||||||
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