Details for New Drug Application (NDA): 219304
✉ Email this page to a colleague
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 five patents protecting this drug. Additional details are available on the ROMVIMZA profile page.
The generic ingredient in ROMVIMZA is vimseltinib. One supplier is listed for this compound. Additional details are available on the vimseltinib profile page.
The generic ingredient in ROMVIMZA is vimseltinib. 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: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219304
Generic Entry Date for 219304*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
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: | 11,103,507 | Patent Expiration: | Feb 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR | ||||||||
| Patent: | 11,679,110 | Patent Expiration: | Feb 3, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR | ||||||||
Complete Access Available with Subscription
