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Generated: November 19, 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 eleven 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 Theraps Inc
Ingredient:glycerol phenylbutyrate
Patents:11
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
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 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, LLC. 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: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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