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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fuji
Accenture
Medtronic
Argus Health
Healthtrust
Fish and Richardson
Citi
Johnson and Johnson

Generated: June 19, 2018

DrugPatentWatch Database Preview

Glycerol phenylbutyrate - Generic Drug Details

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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of glycerol phenylbutyrate patent protection?

Glycerol phenylbutyrate
is the generic ingredient in one branded drug marketed by Horizon Theraps Inc and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Glycerol phenylbutyrate has ninety patent family members in twenty-nine countries.

There are fifty drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound.
Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate
Synonyms for glycerol phenylbutyrate
611168-24-2
AKOS030238862
Benzenebutanoic acid, 1,1',1''-(1,2,3-propanetriyl) ester
BENZENEBUTANOIC ACID, 1,2,3-PROPANETRIYL ESTER
CHEBI:134745
CHEMBL2105745
D0E0BD
D10127
DB08909
DTXSID40210005
Glycerol phenylbutyrate (USAN)
Glycerol phenylbutyrate [USAN]
Glycerolphenylbutyrate
Glyceryl tri-(4-phenylbutyrate)
Glyceryl Tri-4-Phenylbutyrate
GT4P
HPN-100
OR295353
Propane-1,2,3-triyl tris(4-phenylbutanoate)
Ravicti
Ravicti (TN)
SCHEMBL10102804
UNII-ZH6F1VCV7B
ZH6F1VCV7B

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 Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Horizon Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Horizon Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ 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

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Non-Orange Book US Patents for glycerol phenylbutyrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,060,510 Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders ➤ Sign Up
6,083,984 Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for glycerol phenylbutyrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000107 Germany ➤ Sign Up PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
/2016 Austria ➤ Sign Up PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 (MITTEILUNG) 20151201
90060-7 Sweden ➤ Sign Up PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201
2016041 Lithuania ➤ Sign Up PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Deloitte
Citi
Julphar
Chinese Patent Office
Queensland Health
AstraZeneca
UBS
Covington

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