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Serving 500+ biopharmaceutical companies globally:

Colorcon
Moodys
Argus Health
Daiichi Sankyo
Novartis
Queensland Health
US Department of Justice
Johnson and Johnson
Federal Trade Commission
Chinese Patent Office

Generated: July 23, 2017

DrugPatentWatch Database Preview

RAVICTI Drug Profile

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Which patents cover Ravicti, and when can generic versions of Ravicti launch?

Ravicti is a drug marketed by Horizon Theraps Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-six countries.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are forty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

Summary for Tradename: RAVICTI

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list2
Clinical Trials: see list7
Patent Applications: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RAVICTI at DailyMed
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;ORAL203284-001Feb 1, 2013RXYesYes9,561,197► Subscribe ► Subscribe
Horizon Theraps Inc
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL203284-001Feb 1, 2013RXYesYes8,404,215► Subscribe ► Subscribe
Horizon Theraps Inc
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL203284-001Feb 1, 2013RXYesYes5,968,979► SubscribeYY ► Subscribe
Horizon Theraps Inc
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL203284-001Feb 1, 2013RXYesYes► Subscribe► Subscribe
Horizon Theraps Inc
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL203284-001Feb 1, 2013RXYesYes9,326,966► Subscribe ► Subscribe
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Paragraph IV activity for: RAVICTI

Drugname Dosage Strength RLD Submissiondate
glycerol phenylbutyrateOral Liquid1.1 g/mLRavicti11/19/2013

Non-Orange Book Patents for Tradename: RAVICTI

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 Tradename: RAVICTI

Country Document Number Estimated Expiration
Brazil112014007357► Subscribe
United Kingdom2470310► Subscribe
Canada2735218► Subscribe
Mexico2014012694► Subscribe
European Patent Office3133396► 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: RAVICTI

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

Serving 500+ biopharmaceutical companies globally:

Colorcon
QuintilesIMS
US Department of Justice
McKesson
Farmers Insurance
Citi
Chinese Patent Office
Express Scripts
Dow
Merck

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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