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Last Updated: November 14, 2019

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Glycerol phenylbutyrate - Generic Drug Details

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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of patent protection?

Glycerol phenylbutyrate is the generic ingredient in one branded drug marketed by Horizon Therap and is included in one NDA. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glycerol phenylbutyrate has one hundred and one patent family members in twenty-eight countries.

There are fifty-one drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for glycerol phenylbutyrate

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

SponsorPhase
Columbia UniversityEarly Phase 1
University of Alabama at BirminghamPhase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2

See all glycerol phenylbutyrate clinical trials

Recent Litigation for glycerol phenylbutyrate

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 glycerol phenylbutyrate litigation

PTAB Litigation
PetitionerDate
Par Pharmaceutical, Inc.2018-08-21
Lupin, Ltd.2018-01-12
Par Pharmaceutical, Inc.2017-07-13

See all glycerol phenylbutyrate litigation

Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1.1GRAMS/MLLIQUID;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate
Synonyms for glycerol phenylbutyrate
611168-24-2
AKOS030238862
Benzenebutanoic acid, 1,1',1''-(1,2,3-propanetriyl) ester
CHEBI:134745
CHEMBL2105745
CS-0017499
D10127
DB08909
DTXSID40210005
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
Ravicti (TN)
SCHEMBL10102804
Tris(4-phenylbutyryl)glycerol
UNII-ZH6F1VCV7B
ZH6F1VCV7B
Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE
Tradename Dosage Ingredient NDA Submissiondate
RAVICTI LIQUID;ORAL glycerol phenylbutyrate 203284

US Patents and Regulatory Information for glycerol phenylbutyrate

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
>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 glycerol phenylbutyrate

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 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 93351 Luxembourg   Start Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2330892 C20160044 00204 Estonia   Start Trial 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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