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Last Updated: July 3, 2020

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 Therap and is included in one NDA. 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. Additional details are available on the glycerol phenylbutyrate profile page.
Summary for 203284
Tradename:RAVICTI
Applicant:Horizon Therap
Ingredient:glycerol phenylbutyrate
Patents:15
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203284
Generic Entry Date for 203284*:
Constraining patent/regulatory exclusivity:
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
Dosage:
LIQUID;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.

Medical Subject Heading (MeSH) Categories for 203284
Paragraph IV (Patent) Challenges for 203284
Tradename Dosage Ingredient NDA Submissiondate
RAVICTI LIQUID;ORAL glycerol phenylbutyrate 203284

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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