Glycerol phenylbutyrate - Generic Drug Details
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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of freedom to operate?
Glycerol phenylbutyrate
is the generic ingredient in two branded drugs marketed by Par Pharm Inc and Horizon Therap Us, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Glycerol phenylbutyrate has one hundred and fourteen patent family members in twenty-nine countries.
There are two drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for glycerol phenylbutyrate
International Patents: | 114 |
US Patents: | 15 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 10 |
Patent Applications: | 157 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycerol phenylbutyrate |
What excipients (inactive ingredients) are in glycerol phenylbutyrate? | glycerol phenylbutyrate excipients list |
DailyMed Link: | glycerol phenylbutyrate at DailyMed |
Recent Clinical Trials for glycerol phenylbutyrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Columbia University | Early Phase 1 |
Weizmann Institute of Science | Phase 2/Phase 3 |
Kaplan Medical Center | Phase 2/Phase 3 |
Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 1.1G/ML | LIQUID;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for glycerol phenylbutyrate
Drug Class | Nitrogen Binding Agent |
Mechanism of Action | Ammonium Ion Binding Activity |
Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate
Anatomical Therapeutic Chemical (ATC) Classes for glycerol phenylbutyrate
Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE
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 glycerol phenylbutyrate
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 | Y | ⤷ 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 |
Expired US Patents for glycerol phenylbutyrate
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for glycerol phenylbutyrate
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 glycerol phenylbutyrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2014000783 | Metodos para determinar si se necesita usar un farmaco depurador de nitrogeno o para determinar el incremento de una dosificacion del farmaco depurador de nitrogeno en un sujeto que recibe actualmente dicho farmaco; y uso del farmaco depurador de nitrogeno para el tratamiento de un trastorno de retencion de nitrogeno, tal como un trastorno del ciclo de urea y encefalopatia hepatica. | ⤷ Try a Trial |
Spain | 2623470 | ⤷ Try a Trial | |
Lithuania | 2330892 | ⤷ Try a Trial | |
Serbia | 56196 | LEK ZA UKLANJANJE AZOTA ZA UPOTREBU U POSTUPKU LEČENJA POREMEĆAJA NAKUPLJANJA AZOTA (NITROGEN SCAVENGING DRUG FOR USE IN A METHOD OF TREATING A NITROGEN RETENTION DISORDER) | ⤷ Try a Trial |
Slovenia | 2760479 | ⤷ Try a Trial | |
China | 111991383 | 苯乙酸前药的治疗性监测方法 (Methods of therapeutic monitoring of phenylacetic acid prodrugs) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glycerol phenylbutyrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2330892 | 1690060-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201 |
2330892 | 132016000126572 | Italy | ⤷ Try a Trial | PRODUCT NAME: GLICEROLO FENILBUTIRRATO(RAVICTI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1062, 20151201 |
2330892 | CR 2016 00062 | Denmark | ⤷ Try a Trial | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201 |
2330892 | 63/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 (MITTEILUNG) 20151201 |
2330892 | 2016C/074 | Belgium | ⤷ Try a Trial | PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201 |
2330892 | 2016023 | Norway | ⤷ Try a Trial | PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062 20151210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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