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Last Updated: March 21, 2023

Glycerol phenylbutyrate - Generic Drug Details

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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of freedom to operate?

Glycerol phenylbutyrate is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Horizon Therap, and is included in two NDAs. There are sixteen 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 fourteen 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

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
See Plans and PricingSee Plans and Pricing1.1G/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 RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Japan 6425746 See Plans and Pricing
United Kingdom 2470310 Dosing and monitoring patients on nitrogen scavenging drugs See Plans and Pricing
South Korea 20180085823 질소 스캐빈징 약물들의 치료학적 모니터링 방법들 (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycerol phenylbutyrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 C20160044 00204 Estonia See Plans and Pricing PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892 1690060-7 Sweden See Plans and Pricing PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201
2330892 359 5034-2016 Slovakia See Plans and Pricing PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.