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Serving 500+ biopharmaceutical companies globally:

Dow
Novartis
Argus Health
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Citi
McKinsey
US Army
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Generated: September 19, 2017

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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 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 fifty-five patent family members in twenty-seven countries.

There are forty-eight drug master file entries for glycerol phenylbutyrate. Two suppliers are listed for this compound.

Summary for Generic Name: glycerol phenylbutyrate

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list48
Suppliers / Packagers: see list2
Bulk Api Vendors: see list2
Clinical Trials: see list105
Patent Applications: see list6
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:glycerol phenylbutyrate at DailyMed

Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
6,083,984 Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: glycerol phenylbutyrate

Country Document Number Estimated Expiration
European Patent Office2330892► Subscribe
World Intellectual Property Organization (WIPO)9624571► Subscribe
European Patent Office2760479► Subscribe
Australia4858796► Subscribe
Israel231732► Subscribe
China104039358► Subscribe
Slovenia2330892► Subscribe
Slovenia2760479► Subscribe
South Korea20150013170► Subscribe
Denmark2846791► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GLYCEROL PHENYLBUTYRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00062Denmark► SubscribePRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2016 00062Denmark► SubscribePRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2016041Lithuania► SubscribePRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2016000107Germany► SubscribePRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
0854Netherlands► SubscribePRODUCT NAME: GLYCEROLFENYLBUTYRAAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
0160044 00204Estonia► SubscribePRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Julphar
Baxter
Colorcon
Harvard Business School
Accenture
Medtronic
Cantor Fitzgerald
Fuji
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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