Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Mallinckrodt
Dow
Merck
McKinsey

Last Updated: August 11, 2022

RAVICTI Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

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

This drug has one hundred and fourteen 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. 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.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

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 sixteen US patents and one FDA Regulatory Exclusivity.

Patents protecting RAVICTI

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Treatment of urea cycle disorders in neonates and infants
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of phenylacetic acid prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A UREA CYCLE DISORDER

Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Therap RAVICTI glycerol phenylbutyrate LIQUID;ORAL 203284-001 Feb 1, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Lithuania 2846791 See Plans and Pricing
Japan 2014102255 See Plans and Pricing
Canada 2850391 PROCEDES DE SURVEILLANCE THERAPEUTIQUE DE MEDICAMENTS EPURATEURS D'AZOTE (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAVICTI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2330892 C20160044 00204 Estonia See Plans and Pricing PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015
2330892 PA2016041,C2330892 Lithuania See Plans and Pricing PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127
2330892 1690060-7 Sweden See Plans and Pricing PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Mallinckrodt
Harvard Business School
Johnson and Johnson
Medtronic

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.