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QuintilesIMS
Daiichi Sankyo
Express Scripts
Fuji
Dow
Mallinckrodt
Colorcon
US Department of Justice
Medtronic

Generated: December 10, 2018

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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-three 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 ➤ 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 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
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 ➤ Sign Up

Supplementary Protection Certificates for RAVICTI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
16/064 Ireland ➤ Sign Up PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
90060-7 Sweden ➤ Sign Up PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201
2016000107 Germany ➤ Sign Up PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127
0854 Netherlands ➤ Sign Up PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201
0160044 00204 Estonia ➤ Sign Up PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Queensland Health
Chubb
Farmers Insurance
McKinsey
QuintilesIMS
Chinese Patent Office
Fish and Richardson
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.