GLYCEROL PHENYLBUTYRATE Drug Patent Profile
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When do Glycerol Phenylbutyrate patents expire, and what generic alternatives are available?
Glycerol Phenylbutyrate is a drug marketed by Par Pharm Inc and is included in one NDA.
The generic ingredient in GLYCEROL PHENYLBUTYRATE 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.
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Pharm Inc | GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 205742-001 | Dec 2, 2021 | DISCN | No | No | ⤷ 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 |
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 |
