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Last Updated: February 29, 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 five 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. One supplier is listed 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 four 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
Johns Hopkins UniversityPhase 1/Phase 2
Children's Hospital of PhiladelphiaPhase 1/Phase 2
University of Alabama at BirminghamPhase 1/Phase 2

See all RAVICTI clinical trials

Recent Litigation for RAVICTI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Horizon Therapeutics, LLC v. Par Pharmaceuticals, Inc.2018-08-10
HORIZON THERAPEUTICS, LLC v. PAR PHARMACEUTICAL, INC.2016-06-30
Horizon Therapeutics Inc v. Par Pharmaceutical Inc2014-04-23

See all RAVICTI litigation

PTAB Litigation
PetitionerDate
2018-08-21
2018-01-12
2017-07-13

See all RAVICTI litigation

Synonyms for RAVICTI
611168-24-2
AKOS030238862
Benzenebutanoic acid, 1,1',1''-(1,2,3-propanetriyl) ester
CHEBI:134745
CHEMBL2105745
CS-0017499
D10127
DB08909
DTXSID40210005
GLYCEROL PHENYLBUTYRATE
Glycerol phenylbutyrate (USAN)
Glycerol phenylbutyrate [USAN:INN]
Glycerolphenylbutyrate
Glyceryl Tri-4-Phenylbutyrate
GT4P
HPN 100
HPN-100
HY-B2087
Propane-1,2,3-triyl tris(4-phenylbutanoate)
Ravicti (TN)
SCHEMBL10102804
Tris(4-phenylbutyryl)glycerol
UNII-ZH6F1VCV7B
ZH6F1VCV7B
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 16C1020 France   Start Trial PRODUCT NAME: PHENYLBUTYRATE DE GLYCEROL; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892 CR 2016 00062 Denmark   Start Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 300854 Netherlands   Start Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892 2016/064 Ireland   Start Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892 122016000107 Germany   Start Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 93351 Luxembourg   Start Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Johnson and Johnson
Express Scripts
McKesson
Merck

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