Details for New Drug Application (NDA): 207999
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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: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 17, 2033 | Product Flag? | Substance Flag? | Y | 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 | 207999-002 | May 27, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-001 | May 27, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Intercept Pharms Inc | OCALIVA | obeticholic acid | TABLET;ORAL | 207999-002 | May 27, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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