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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Chubb
Novartis
Healthtrust
Covington
Harvard Business School
US Army
Accenture
Dow

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203284

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NDA 203284 describes RAVICTI, which is a drug marketed by Horizon Theraps Inc and is included in one NDA. It is available from one supplier. There are seven 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 forty-eight 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 Theraps Inc
Ingredient:glycerol phenylbutyrate
Patents:7
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203284
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, LLC. 75987-050 N 75987-050-06
RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284 NDA Horizon Therapeutics, LLC. 75987-050 N 75987-050-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;ORALStrength1.1GM/ML
Approval Date:Feb 1, 2013TE: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
Regulatory Exclusivity Expiration:Apr 28, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 1, 2020
Regulatory Exclusivity Use:USE AS A NITROGEN-BINDING ADJUNCTIVE THERAPY FOR CHRONIC MGMT OF ADULT AND PEDIATRIC PATIENTS AT LEAST 2 YRS WITH UREA CYCLE DISORDERS THAT CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE

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Julphar
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