Tovorafenib - Generic Drug Details
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What are the generic drug sources for tovorafenib and what is the scope of patent protection?
Tovorafenib
is the generic ingredient in one branded drug marketed by Day One Biopharms and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tovorafenib has forty-nine patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for tovorafenib
International Patents: | 49 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
Patent Applications: | 165 |
What excipients (inactive ingredients) are in tovorafenib? | tovorafenib excipients list |
DailyMed Link: | tovorafenib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tovorafenib
Generic Entry Dates for tovorafenib*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;ORAL |
Generic Entry Dates for tovorafenib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for tovorafenib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
SIOPe Brain Tumor Group LOGGIC Consortium | Phase 3 |
Day One Biopharmaceuticals, Inc. | Phase 3 |
US Patents and Regulatory Information for tovorafenib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Day One Biopharms | OJEMDA | tovorafenib | FOR SUSPENSION;ORAL | 218033-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Day One Biopharms | OJEMDA | tovorafenib | FOR SUSPENSION;ORAL | 218033-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Day One Biopharms | OJEMDA | tovorafenib | TABLET;ORAL | 217700-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for tovorafenib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101650140 | ⤷ Sign Up | |
China | 101784545 | Compounds useful as raf kinase inhibitors | ⤷ Sign Up |
Chile | 2008001933 | Compuestos derivados de pirimidina, inhibidores de la raf quinasa; compuestos intermediarios; procedimiento de preparacion; composicion farmaceutica; y su uso para tratar trastornos proliferativos, cardiacos, neurodegenerativos, inflamatorios, oseos, inmunologicos enfermedad viral, entre otros. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |