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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
Fish and Richardson
Johnson and Johnson
Farmers Insurance
Mallinckrodt
Federal Trade Commission
Harvard Business School
Julphar

Generated: May 26, 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. 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: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 N 69516-005-30
OCALIVA obeticholic acid TABLET;ORAL 207999 NDA Intercept Pharmaceuticals Inc 69516-010 N 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: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:➤ Sign UpPatent Expiration:Nov 16, 2022Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Cipla
McKinsey
Chinese Patent Office
Julphar
Merck
Deloitte
Cerilliant

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