Details for New Drug Application (NDA): 203284

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NDA 203284 describes RAVICTI, which is a drug marketed by Horizon Therap Us and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAVICTI profile page.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are fifty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

Summary for 203284

Tradename:	RAVICTI
Applicant:	Horizon Therap Us
Ingredient:	glycerol phenylbutyrate
Patents:	15

Pharmacology for NDA: 203284

Mechanism of Action	Ammonium Ion Binding Activity

Medical Subject Heading (MeSH) Categories for 203284

Cryoprotective Agents
Solvents

Suppliers and Packaging for NDA: 203284

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050	75987-050-06	1 BOTTLE in 1 CARTON (75987-050-06) / 25 mL in 1 BOTTLE
RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284	NDA	Horizon Therapeutics USA, Inc.	75987-050	75987-050-07	4 BOTTLE in 1 CARTON (75987-050-07) / 25 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;ORAL			Strength	1.1GM/ML
Approval Date:	Feb 1, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 28, 2024
Regulatory Exclusivity Use:	FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF A UREA CYCLE DISORDER
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF A UREA CYCLE DISORDER

Expired US Patents for NDA 203284

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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