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Last Updated: July 28, 2021

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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 twelve patent family members in twenty-nine countries.

There are fifty-one 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
Weill Medical College of Cornell UniversityEarly Phase 1
Columbia UniversityEarly Phase 1
University of Alabama at BirminghamPhase 1/Phase 2

See all GLYCEROL PHENYLBUTYRATE clinical trials

Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for GLYCEROL PHENYLBUTYRATE

Country Patent Number Estimated Expiration
Denmark 2846791 ⤷  Free Forever Trial
China 104540507 ⤷  Free Forever Trial
European Patent Office 2338050 ⤷  Free Forever Trial
European Patent Office 3263102 ⤷  Free Forever Trial
Cyprus 1121288 ⤷  Free Forever Trial
Spain 2629859 ⤷  Free Forever Trial
Spain 2695534 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for GLYCEROL PHENYLBUTYRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 132016000126572 Italy ⤷  Free Forever Trial PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201
2330892 2016C/074 Belgium ⤷  Free Forever Trial PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201
2330892 122016000107 Germany ⤷  Free Forever Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 93351 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062
2330892 CR 2016 00062 Denmark ⤷  Free Forever Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 PA2016041 Lithuania ⤷  Free Forever Trial PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 300854 Netherlands ⤷  Free Forever Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Moodys
Colorcon
Baxter
AstraZeneca

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