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Glycerol phenylbutyrate - Generic Drug Details
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What are the generic drug sources for glycerol phenylbutyrate and what is the scope of glycerol phenylbutyrate patent protection?
Glycerol phenylbutyrate has ninety patent family members in twenty-nine countries.
There are fifty drug master file entries for glycerol phenylbutyrate. One supplier is listed for this compound.
Summary for glycerol phenylbutyrate
| International Patents: | 90 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 50 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 6 |
| Clinical Trials: | 106 |
| 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 | Y | Y | ➤ 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 | ||||
| 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 |
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Non-Orange Book US Patents for glycerol phenylbutyrate
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,060,510 | Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders | ➤ Sign Up |
| 6,083,984 | Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in the treatment of various disorders | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for glycerol phenylbutyrate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Brazil | 112014007357 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2009134460 | ➤ Sign Up |
| Portugal | 2760479 | ➤ Sign Up |
| Canada | 2735218 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for glycerol phenylbutyrate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016000107 | Germany | ➤ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
| /2016 | Austria | ➤ Sign Up | PRODUCT NAME: GLYCEROLPHENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 (MITTEILUNG) 20151201 |
| 90060-7 | Sweden | ➤ Sign Up | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201 |
| 2016041 | Lithuania | ➤ Sign Up | PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
