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Last Updated: October 10, 2024

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 seven 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:7
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
Patent:⤷  Sign UpPatent Expiration:Sep 6, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent:⤷  Sign UpPatent Expiration:Apr 26, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 17, 2033Product Flag?Substance Flag?YDelist 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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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 verification 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.