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Moodys
Cantor Fitzgerald
Mallinckrodt
US Army
Harvard Business School
Accenture
Dow
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Generated: August 21, 2018

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in twenty-nine countries.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are fifty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

Drug patent expirations by year for RAVICTI
Generic Entry Opportunity Date for RAVICTI
Generic Entry Date for RAVICTI*:
Constraining patent/regulatory exclusivity:
FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE
NDA:
Dosage:
LIQUID;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for RAVICTI
Synonyms for RAVICTI
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
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 (TN)
SCHEMBL10102804
UNII-ZH6F1VCV7B
ZH6F1VCV7B

US Patents and Regulatory Information for RAVICTI

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Horizon Theraps Inc RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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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Paragraph IV (Patent) Challenges for RAVICTI
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Liquid 1.1 g/mL ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for 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 ➤ Try a Free Trial
9,962,358 Methods of therapeutic monitoring of nitrogen scavenging drugs ➤ Try a Free Trial
6,083,984 Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for RAVICTI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160044 00204 Estonia ➤ Try a Free Trial PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2016 00062 Denmark ➤ Try a Free Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2016041 Lithuania ➤ Try a Free Trial 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:

Moodys
Argus Health
Johnson and Johnson
Julphar
Accenture
QuintilesIMS
Chubb
Boehringer Ingelheim
McKinsey

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