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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Boehringer Ingelheim

Generated: January 18, 2018

DrugPatentWatch Database Preview

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 207999
Applicant:Intercept Pharms Inc
Ingredient:obeticholic acid
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 27, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 27, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:➤ SubscribePatent Expiration:Nov 16, 2022Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Chinese Patent Office
US Army
Harvard Business School

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