Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
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Colorcon
AstraZeneca

Last Updated: October 16, 2019

DrugPatentWatch Database Preview

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 one 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.

Drug patent expirations by year for RAVICTI
Drug Prices for RAVICTI

See drug prices for RAVICTI

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

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
Par Pharmaceutical, Inc.2018-08-21
Lupin, Ltd.2018-01-12
Par Pharmaceutical, Inc.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

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   See Pricing   See Pricing   See Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   See Pricing   See Pricing   See Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   See Pricing   See Pricing   See Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for RAVICTI
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Liquid 1.1 g/mL ➤ Subscribe   See Pricing

Supplementary Protection Certificates for RAVICTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 PA2016041,C2330892 Lithuania   See Pricing PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 122016000107 Germany   See Pricing PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 PA2016041 Lithuania   See Pricing PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 C20160044 00204 Estonia   See Pricing PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Express Scripts
Johnson and Johnson
Merck
McKesson

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 verifification 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.