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Glycerol phenylbutyrate - Generic Drug Details
What are the generic drug sources for glycerol phenylbutyrate and what is the scope of glycerol phenylbutyrate patent protection?
Glycerol phenylbutyrate
is the generic ingredient in one branded drug marketed by Horizon Theraps Inc and is included in one NDA. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are fifty-one drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound.
Summary for glycerol phenylbutyrate
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 51 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 6 |
| Clinical Trials: | 6 |
| Patent Applications: | 10 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for glycerol phenylbutyrate |
| DailyMed Link: | glycerol phenylbutyrate at DailyMed |
Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate
Synonyms for glycerol phenylbutyrate
| 611168-24-2 |
| AKOS030238862 |
| Benzenebutanoic acid, 1,1',1''-(1,2,3-propanetriyl) ester |
| BENZENEBUTANOIC ACID, 1,2,3-PROPANETRIYL ESTER |
| CHEBI:134745 |
| CHEMBL2105745 |
| D0E0BD |
| D10127 |
| DB08909 |
| DTXSID40210005 |
| Glycerol phenylbutyrate (USAN) |
| Glycerol phenylbutyrate [USAN] |
| Glycerolphenylbutyrate |
| Glyceryl tri-(4-phenylbutyrate) |
| Glyceryl Tri-4-Phenylbutyrate |
| GT4P |
| HPN-100 |
| OR295353 |
| Propane-1,2,3-triyl tris(4-phenylbutanoate) |
| Ravicti |
| Ravicti (TN) |
| SCHEMBL10102804 |
| UNII-ZH6F1VCV7B |
| ZH6F1VCV7B |
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 Theraps Inc | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Theraps Inc | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Theraps Inc | 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 glycerol phenylbutyrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Horizon Theraps Inc | 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 |
International Patents for glycerol phenylbutyrate
Supplementary Protection Certificates for glycerol phenylbutyrate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016 00062 | Denmark | ➤ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201 |
| 2016 00062 | Denmark | ➤ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REG. NO/DATE: EU/1/15/1062/001-004 20151201 |
| 0854 | Netherlands | ➤ Sign Up | PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
