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Last Updated: May 19, 2022

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 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. 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:10
DrugPatentWatch® Estimated 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.

Pharmacology for NDA: 207999
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, 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:See Plans and PricingPatent Expiration:Sep 6, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent:See Plans and PricingPatent Expiration:Apr 26, 2036Product Flag?YSubstance Flag?Delist 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 207999-001 May 27, 2016 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 See Plans and Pricing See Plans and Pricing
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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