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 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. Additional details are available on the obeticholic acid profile page.

Summary for 207999

Tradename:	OCALIVA
Applicant:	Intercept Pharms Inc
Ingredient:	obeticholic acid
Patents:	7

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 27, 2016	TE:		RLD:	Yes
Patent:	10,047,117	Patent Expiration:	Sep 6, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent:	10,052,337	Patent Expiration:	Apr 26, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,174,073	Patent Expiration:	Jun 17, 2033	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 207999

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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	8,058,267	⤷ Start Trial
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	7,138,390	⤷ Start Trial
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	8,377,916	⤷ Start Trial
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	7,138,390	⤷ Start Trial
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	8,058,267	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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