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 Endo Operations 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.
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Summary for GLYCEROL PHENYLBUTYRATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 33 |
| Clinical Trials: | 11 |
| Patent Applications: | 51 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GLYCEROL PHENYLBUTYRATE |
| DailyMed Link: | GLYCEROL PHENYLBUTYRATE at DailyMed |
Recent Clinical Trials for GLYCEROL PHENYLBUTYRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Technical University of Munich | Phase 2 |
| Columbia University | Early Phase 1 |
| Kaplan Medical Center | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | GLYCEROL PHENYLBUTYRATE | glycerol phenylbutyrate | LIQUID;ORAL | 205742-001 | Dec 2, 2021 | DISCN | No | No | ⤷ 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 |
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 |
