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Last Updated: July 12, 2020

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RAVICTI Drug Profile


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Which patents cover Ravicti, and when can generic versions of Ravicti launch?

Ravicti 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.

This drug has one hundred and seven patent family members in twenty-eight countries.

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.

US ANDA Litigation and Generic Entry Outlook for Ravicti

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2024. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (glycerol phenylbutyrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for RAVICTI
Drug Prices for RAVICTI

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Generic Entry Opportunity Date for RAVICTI
Generic Entry Date for RAVICTI*:
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
NDA:
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.

Recent Clinical Trials for RAVICTI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital of PhiladelphiaPhase 1/Phase 2
University of Alabama at BirminghamPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2

See all RAVICTI clinical trials

Paragraph IV (Patent) Challenges for RAVICTI
Tradename Dosage Ingredient NDA Submissiondate
RAVICTI LIQUID;ORAL glycerol phenylbutyrate 203284

US Patents and Regulatory Information for RAVICTI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for RAVICTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 CA 2016 00062 Denmark   Start Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 C20160044 00204 Estonia   Start Trial PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892 2016C/074 Belgium   Start Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201
2330892 132016000126572 Italy   Start Trial PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201
2330892 PA2016041 Lithuania   Start Trial PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 2016023 Norway   Start Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Mallinckrodt
Harvard Business School
Johnson and Johnson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.