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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 patent protection?
Glycerol phenylbutyrate
is the generic ingredient in one branded drug marketed by Horizon Therap and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Glycerol phenylbutyrate has one hundred and eleven patent family members in twenty-nine countries.
There are fifty-one drug master file entries for glycerol phenylbutyrate. There is one tentative approval for this compound.
Summary for glycerol phenylbutyrate
| International Patents: | 111 |
| US Patents: | 16 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 51 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 7 |
| Patent Applications: | 78 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Columbia University | Early Phase 1 |
| Johns Hopkins University | Phase 1/Phase 2 |
| Children's Hospital of Philadelphia | Phase 1/Phase 2 |
Generic filers with tentative approvals for GLYCEROL PHENYLBUTYRATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 1.1GRAMS/ML | LIQUID;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for glycerol phenylbutyrate
Paragraph IV (Patent) Challenges for GLYCEROL PHENYLBUTYRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RAVICTI | LIQUID;ORAL | glycerol phenylbutyrate | 203284 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 Therap | RAVICTI | glycerol phenylbutyrate | LIQUID;ORAL | 203284-001 | Feb 1, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for glycerol phenylbutyrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ecuador | SP14024561 | Start Trial |
| Japan | 2015514757 | Start Trial |
| Hong Kong | 1243959 | Start Trial |
| Lithuania | 3133396 | Start Trial |
| Hungary | E032726 | Start Trial |
| Mexico | 365302 | Start Trial |
| Cyprus | 1121288 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for glycerol phenylbutyrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2330892 | 359 5034-2016 | Slovakia | Start Trial | PRODUCT NAME: GLYCEROLFENYLBUTYRAT; REGISTRATION NO/DATE: EU/1/15/1062 20151201 |
| 2330892 | PA2016041,C2330892 | Lithuania | Start Trial | PRODUCT NAME: GLICEROLIO FENILBUTIRATAS; REGISTRATION NO/DATE: EU/1/15/1062 20151127 |
| 2330892 | 93351 | Luxembourg | Start Trial | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 |
| 2330892 | 1690060-7 | Sweden | Start Trial | PRODUCT NAME: GLYCEROL PHENYLBUTYRATE; REG. NO/DATE: EU/1/15/1062 20151201 |
| 2330892 | 2016C/074 | Belgium | Start Trial | PRODUCT NAME: GLYCEROLFENYLBUTYRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1062 20151201 |
| 2330892 | C20160044 00204 | Estonia | Start Trial | PRODUCT NAME: GLUETSEROOLFENUEUELBUTUERAAT;REG NO/DATE: EU/1/15/1062 01.12.2015 |
| 2330892 | 300854 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
