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Last Updated: January 21, 2021

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. There are ten 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. Additional details are available on the obeticholic acid profile page.
Summary for 207999
Tradename:OCALIVA
Applicant:Intercept Pharms Inc
Ingredient:obeticholic acid
Patents:10
Generic Entry Opportunity Date for 207999
Generic Entry Date for 207999*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for 207999
Tradename Dosage Ingredient NDA Submissiondate
OCALIVA TABLET;ORAL obeticholic acid 207999 2020-05-27

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:
Regulatory Exclusivity Expiration:May 27, 2023
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Sep 6, 2033Product Flag?Substance Flag?Delist Request?

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