Details for New Drug Application (NDA): 217700
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NDA 217700 describes OJEMDA, which is a drug marketed by Day One Biopharms and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the OJEMDA profile page.
The generic ingredient in OJEMDA is tovorafenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tovorafenib profile page.
The generic ingredient in OJEMDA is tovorafenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tovorafenib profile page.
Summary for 217700
| Tradename: | OJEMDA |
| Applicant: | Day One Biopharms |
| Ingredient: | tovorafenib |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217700
Generic Entry Date for 217700*:
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.
Pharmacology for NDA: 217700
| Mechanism of Action | Cytochrome P450 3A Inducers Type II RAF Kinase Inhibitors |
Suppliers and Packaging for NDA: 217700
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OJEMDA | tovorafenib | TABLET;ORAL | 217700 | NDA | Day One Biopharmaceuticals, Inc. | 82950-001 | 82950-001-16 | 4 BLISTER PACK in 1 CARTON (82950-001-16) / 4 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-04) |
| OJEMDA | tovorafenib | TABLET;ORAL | 217700 | NDA | Day One Biopharmaceuticals, Inc. | 82950-001 | 82950-001-20 | 4 BLISTER PACK in 1 CARTON (82950-001-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK (82950-001-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 23, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 23, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Apr 23, 2031 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | 10,426,782 | Patent Expiration: | Jun 23, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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