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:
TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION Dosage:
FOR SUSPENSION;ORAL |
Generic Entry Dates for tovorafenib*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PATIENTS 6 MONTHS OF AGE AND OLDER WITH RELAPSED OR REFRACTORY PEDIATRIC LOW-GRADE GLIOMA (LGG) HARBORING A BRAF FUSION OR REARRANGEMENT, OR BRAF V600 MUTATION 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 |
| Day One Biopharmaceuticals, Inc. | Phase 3 |
| SIOPe Brain Tumor Group LOGGIC Consortium | 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 | TABLET;ORAL | 217700-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Day One Biopharms | OJEMDA | tovorafenib | TABLET;ORAL | 217700-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Day One Biopharms | OJEMDA | tovorafenib | TABLET;ORAL | 217700-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Day One Biopharms | OJEMDA | tovorafenib | TABLET;ORAL | 217700-001 | Apr 23, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 |
|---|---|---|---|
| Costa Rica | 20160483 | FORMULACIONES FARMACÉUTICAS, PROCESOS PARA LA PREPARACIÓN Y MÉTODOS DE USO | ⤷ Subscribe |
| Dominican Republic | P2016000254 | FORMULACIONES FARMECEUTICAS DE INHIBIDOR DE LA QUINASA PAN-RAF, PROCEDIMIENTOS PARA SU PREPARACION, Y METODOS DE USO. | ⤷ Subscribe |
| Colombia | 2016003340 | Formulaciones farmacéuticas, procesos para la preparación y métodos de uso | ⤷ Subscribe |
| South Korea | 101764076 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
