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Last Updated: November 28, 2020

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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 freedom to operate?

Glycerol phenylbutyrate is the generic ingredient in one branded drug marketed by Horizon Therap and is included in one NDA. 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 nine patent family members in twenty-eight countries.

There are fifty-one drug master file entries for glycerol phenylbutyrate. 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

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
Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE
Tradename Dosage Ingredient NDA Submissiondate
RAVICTI LIQUID;ORAL glycerol phenylbutyrate 203284 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   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 359 5034-2016 Slovakia   Start Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
2330892 PA2016041 Lithuania   Start Trial PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 2016023 Norway   Start Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210
2330892 16C1020 France   Start Trial PRODUCT NAME: PHENYLBUTYRATE DE GLYCEROL; REGISTRATION NO/DATE: EU/1/15/1062 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
McKesson

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