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Last Updated: March 28, 2024

RAVICTI Drug Patent Profile


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When do Ravicti patents expire, and when can generic versions of Ravicti launch?

Ravicti is a drug marketed by Horizon Therap Us and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirteen 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.

DrugPatentWatch® Generic Entry Outlook for Ravicti

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (glycerol phenylbutyrate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for RAVICTI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAVICTI Oral Liquid glycerol phenylbutyrate 1.1 g/mL 203284 1 2013-11-19

US Patents and Regulatory Information for RAVICTI

RAVICTI is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Patents protecting RAVICTI

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Treatment of urea cycle disorders in neonates and infants
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER

Methods of treatment using ammonia-scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of phenylacetic acid prodrugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

FDA Regulatory Exclusivity protecting RAVICTI

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
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon Therap Us RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for RAVICTI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Immedica Pharma AB Ravicti glycerol phenylbutyrate EMEA/H/C/003822
Ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate-synthase-I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).
Authorised no no yes 2015-11-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RAVICTI

See the table below for patents covering RAVICTI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2010025303 ⤷  Try a Trial
Mexico 366197 METODO DE MONITOREO TERAPEUTICO DE FARMACOS DEPURADORES DE NITROGENO. (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS.) ⤷  Try a Trial
European Patent Office 2338050 DOSAGE ET SURVEILLANCE DE PATIENTS EN TRAITEMENT PAR DES MÉDICAMENTS DÉSACTIVANT L'AZOTE (DOSING AND MONITORING PATIENTS ON NITROGEN-SCAVENGING DRUGS) ⤷  Try a Trial
Poland 2330892 ⤷  Try a Trial
Slovenia 3133396 ⤷  Try a Trial
South Korea 20180085823 질소 스캐빈징 약물들의 치료학적 모니터링 방법들 (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAVICTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 CR 2016 00062 Denmark ⤷  Try a Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 300854 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2330892 CA 2016 00062 Denmark ⤷  Try a Trial PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201
2330892 C20160044 00204 Estonia ⤷  Try a Trial PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892 635 Finland ⤷  Try a Trial
2330892 2016/064 Ireland ⤷  Try a Trial PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.