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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 four patents protecting this drug. Additional details are available on the OCALIVA profile page.

The generic ingredient in OCALIVA is obeticholic acid. One supplier is listed for this compound. Additional details are available on the obeticholic acid profile page.

Summary for NDA: 207999

Tradename:
OCALIVA
Applicant:
Intercept Pharms Inc
Ingredient:
obeticholic acid
Patents:4

Pharmacology for NDA: 207999

Mechanism of ActionFarnesoid 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 27, 2016TE:RLD:No
Patent:7,138,390Patent Expiration:Nov 16, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:9,238,673Patent Expiration:Jun 17, 2033Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:May 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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