ravicti Drug Patent Profile
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Which patents cover Ravicti, and what generic alternatives are available?
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 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. 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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Summary for ravicti
International Patents: | 114 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 10 |
Patent Applications: | 51 |
Drug Prices: | Drug price information for ravicti |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ravicti |
What excipients (inactive ingredients) are in ravicti? | ravicti excipients list |
DailyMed Link: | ravicti at DailyMed |
Recent Clinical Trials for ravicti
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Weizmann Institute of Science | Phase 2/Phase 3 |
Kaplan Medical Center | Phase 2/Phase 3 |
Children's Hospital of Philadelphia | Phase 1/Phase 2 |
Pharmacology for ravicti
Drug Class | Nitrogen Binding Agent |
Mechanism of Action | Ammonium Ion Binding Activity |
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
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Treatment of urea cycle disorders in neonates and infants
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging
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Patented Use: DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
Methods of treatment using ammonia-scavenging drugs
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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
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of phenylacetic acid prodrugs
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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
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Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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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: ⤷ Sign Up
Expired US Patents for ravicti
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Denmark | 2760479 | ⤷ Sign Up | |
Brazil | 112014026138 | métodos de monitoramento terapêutico de pró-fármacos de ácido fenilacético | ⤷ Sign Up |
Japan | 2014102255 | TREATMENT METHOD USING AMMONIA-SCAVENGING DRUGS | ⤷ Sign Up |
European Patent Office | 3222275 | PROCÉDÉS DE SURVEILLANCE THÉRAPEUTIQUE DE PROMÉDICAMENTS À BASE D'ACIDE PHÉNYLACÉTIQUE (METHODS OF THERAPEUTIC MONITORING OF PHENYLACETIC ACID PRODRUGS) | ⤷ Sign Up |
Lithuania | 2330892 | ⤷ Sign Up | |
Hungary | E035220 | ⤷ Sign Up | |
Hungary | E032726 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ravicti
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2330892 | 93351 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 |
2330892 | 635 | Finland | ⤷ Sign Up | |
2330892 | 2016023 | Norway | ⤷ Sign Up | PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210 |
2330892 | 359 5034-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
2330892 | PA2016041 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
2330892 | C20160044 00204 | Estonia | ⤷ Sign Up | PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015 |
2330892 | 122016000107 | Germany | ⤷ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |