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Last Updated: November 13, 2024

GLYCEROL PHENYLBUTYRATE Drug Patent Profile


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When do Glycerol Phenylbutyrate patents expire, and what generic alternatives are available?

Glycerol Phenylbutyrate is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in GLYCEROL PHENYLBUTYRATE 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.

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Drug patent expirations by year for GLYCEROL PHENYLBUTYRATE
Recent Clinical Trials for GLYCEROL PHENYLBUTYRATE

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SponsorPhase
Technical University of MunichPhase 2
Columbia UniversityEarly Phase 1
Weizmann Institute of SciencePhase 2/Phase 3

See all GLYCEROL PHENYLBUTYRATE clinical trials

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
Endo Operations GLYCEROL PHENYLBUTYRATE glycerol phenylbutyrate LIQUID;ORAL 205742-001 Dec 2, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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