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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.Glycerol phenylbutyrate has ninety-three patent family members in twenty-nine countries.
There are fifty-one drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound.
Summary for glycerol phenylbutyrate
| International Patents: | 93 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 51 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| 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 | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Horizon Theraps Inc | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Horizon Theraps Inc | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 Theraps Inc | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for glycerol phenylbutyrate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9624571 | ➤ Try a Free Trial |
| Israel | 235127 | ➤ Try a Free Trial |
| United Kingdom | 201013468 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for glycerol phenylbutyrate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016041 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
| C1020 | France | ➤ Try a Free Trial | PRODUCT NAME: PHENYLBUTYRATE DE GLYCEROL; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
| 90060-7 | Sweden | ➤ Try a Free Trial | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
