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, and is included in two NDAs. There are sixteen 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: | 16 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 10 |
| Patent Applications: | 271 |
| 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 |
| Kaplan Medical Center | Phase 2/Phase 3 |
| Weizmann Institute of Science | Phase 2/Phase 3 |
Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
| Applicant | Application No. | Strength | Dosage Form |
| See Plans and Pricing | See Plans and Pricing | 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.
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 | 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 |
Expired US Patents for glycerol phenylbutyrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | See Plans and Pricing | See Plans and Pricing |
| >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 |
|---|---|---|---|
| Japan | 6425746 | See Plans and Pricing | |
| United Kingdom | 2470310 | Dosing and monitoring patients on nitrogen scavenging drugs | See Plans and Pricing |
| South Korea | 20180085823 | 질소 스캐빈징 약물들의 치료학적 모니터링 방법들 (METHODS OF THERAPEUTIC MONITORING OF NITROGEN SCAVENGING DRUGS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for glycerol phenylbutyrate
| 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 | 1690060-7 | Sweden | See Plans and Pricing | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201 |
| 2330892 | 359 5034-2016 | Slovakia | See Plans and Pricing | PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
