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Last Updated: April 25, 2024

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 two branded drugs marketed by Par Pharm Inc and Horizon Therap Us, and is included in two NDAs. 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 thirteen patent family members in twenty-nine countries.

There are two 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
Kaplan Medical CenterPhase 2/Phase 3
Weizmann Institute of SciencePhase 2/Phase 3

See all glycerol phenylbutyrate clinical trials

Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1.1G/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
Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAVICTI Oral Liquid glycerol phenylbutyrate 1.1 g/mL 203284 1 2013-11-19

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

EU/EMA Drug Approvals for glycerol phenylbutyrate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Immedica Pharma AB Ravicti glycerol phenylbutyrate EMEA/H/C/003822
Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
Authorised no no yes 2015-11-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for glycerol phenylbutyrate

Country Patent Number Title Estimated Expiration
Chile 2017001375 Métodos de monitoreo terapéutico de profármacos de ácido fenilacético. ⤷  Try a Trial
China 111991383 苯乙酸前药的治疗性监测方法 (Methods of therapeutic monitoring of phenylacetic acid prodrugs) ⤷  Try a Trial
Japan 6073898 ⤷  Try a Trial
Hungary E035220 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycerol phenylbutyrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 635 Finland ⤷  Try a Trial
2330892 PA2016041,C2330892 Lithuania ⤷  Try a Trial PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 C20160044 00204 Estonia ⤷  Try a Trial PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892 122016000107 Germany ⤷  Try a Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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