RAVICTI Drug Patent Profile
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Which patents cover Ravicti, 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 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
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: | 86 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Kaplan Medical Center | Phase 2/Phase 3 |
| Weizmann Institute of Science | Phase 2/Phase 3 |
| National Jewish Health | Phase 1/Phase 2 |
Pharmacology for RAVICTI
| Drug Class | Nitrogen Binding Agent |
| Mechanism of Action | Ammonium Ion Binding Activity |
Anatomical Therapeutic Chemical (ATC) Classes for RAVICTI
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Treatment of urea cycle disorders in neonates and infants
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging
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Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of phenylacetic acid prodrugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF A UREA CYCLE DISORDER
Methods of therapeutic monitoring of nitrogen scavenging drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon Therap Us | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon Therap Us | 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 |
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 |
|---|---|---|---|
| China | 111991383 | 苯乙酸前药的治疗性监测方法 (Methods of therapeutic monitoring of phenylacetic acid prodrugs) | ⤷ Sign Up |
| Japan | 2015514757 | フェニル酢酸プロドラッグの治療モニタリングの方法 | ⤷ Sign Up |
| European Patent Office | 3133396 | PROCÉDÉS DE TRAITEMENT À L'AIDE DE MÉDICAMENTS DÉSACTIVANT L'AMMONIAC (METHODS OF TREATMENT USING AMMONIA-SCAVENGING DRUGS) | ⤷ Sign Up |
| Turkey | 201816616 | ⤷ Sign Up | |
| Cyprus | 2016053 | ⤷ 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 | 300854 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2330892 | 132016000126572 | Italy | ⤷ Sign Up | PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201 |
| 2330892 | 2016/064 | Ireland | ⤷ Sign Up | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
| 2330892 | CA 2016 00062 | Denmark | ⤷ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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