Details for New Drug Application (NDA): 219304
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NDA 219304 describes ROMVIMZA, which is a drug marketed by Deciphera Pharms and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ROMVIMZA profile page.
The generic ingredient in ROMVIMZA is vimseltinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vimseltinib profile page.
The generic ingredient in ROMVIMZA is vimseltinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vimseltinib profile page.
Summary for 219304
| Tradename: | ROMVIMZA |
| Applicant: | Deciphera Pharms |
| Ingredient: | vimseltinib |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219304
Generic Entry Date for 219304*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 219304
Suppliers and Packaging for NDA: 219304
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROMVIMZA | vimseltinib | CAPSULE;ORAL | 219304 | NDA | Deciphera Pharmaceuticals, LLC | 73207-302 | 73207-302-40 | 1 CARTON in 1 CARTON (73207-302-40) / 1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK |
| ROMVIMZA | vimseltinib | CAPSULE;ORAL | 219304 | NDA | Deciphera Pharmaceuticals, LLC | 73207-302 | 73207-302-41 | 1 CARTON in 1 CARTON (73207-302-41) / 1 BLISTER PACK in 1 CARTON / 4 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 14MG | ||||
| Approval Date: | Feb 14, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 14, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR | ||||||||
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