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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


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
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)
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:Yes
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.