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Last Updated: November 30, 2022

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, 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. There is one tentative approval for this compound.

Summary for glycerol phenylbutyrate
Recent Clinical Trials for glycerol phenylbutyrate

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

SponsorPhase
Columbia UniversityEarly Phase 1
Weizmann Institute of SciencePhase 2/Phase 3
Kaplan Medical CenterPhase 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
European Patent Office 3263102 PROCÉDÉS DE SURVEILLANCE THÉRAPEUTIQUE DE MÉDICAMENTS À RÉCUPÉRATION D'AZOTE (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS) See Plans and Pricing
European Patent Office 2846791 HPN-100 DESTINÉE AU TRAITEMENT DES MALADIES DE LA RÉTENTION AZOTÉE (HPN-100 FOR USE IN THE TREATMENT OF NITROGEN RETENTION DISORDERS) See Plans and Pricing
South Korea 20140094517 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 132016000126572 Italy See Plans and Pricing PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): 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
2330892 CR 2016 00062 Denmark See Plans and Pricing PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Boehringer Ingelheim
McKinsey
AstraZeneca
Medtronic

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