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 Action	Farnesoid 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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 27, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 6, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC)
Patent:	⤷ Sign Up	Patent Expiration:	Apr 26, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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	⤷ Sign Up	⤷ Sign Up
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	207999-001	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-002	May 27, 2016	⤷ Sign Up	⤷ Sign Up
Intercept Pharms Inc	OCALIVA	obeticholic acid	TABLET;ORAL	207999-001	May 27, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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