FDA Orange Book
Is there a generic for Romvimza?
Romvimza contains vimseltinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Romvimza (vimseltinib). The Orange Book shows its last listed patent expires April 30, 2045 and its last listed exclusivity ends February 14, 2030.
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Romvimza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 14MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 20MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 30MG | Marketed (Rx) | None | 0 | None |
NDA 219304, held by DECIPHERA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Romvimza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9181223 | March 14, 2034 | Drug substance, Drug product | None | 219304 |
| 12285430 | December 23, 2039 | Method of use | U-4145 | 219304 |
| 12485120 | December 23, 2039 | Method of use | U-4145 | 219304 |
| 12582655 | December 23, 2039 | Method of use | U-4145 | 219304 |
| 11679110 | February 3, 2040 | Method of use | U-4145 | 219304 |
| 11103507 | February 3, 2040 | Method of use | U-4145 | 219304 |
| 12528787 | December 6, 2044 | Drug substance, Drug product | None | 219304 |
| 12643883 | December 6, 2044 | Drug substance, Drug product | None | 219304 |
| 12447149 | December 6, 2044 | Drug product | None | 219304 |
| 12617775 | December 6, 2044 | Drug substance, Drug product | None | 219304 |
| 12551483 | December 6, 2044 | Drug product | None | 219304 |
| 12686672 | April 30, 2045 | Drug product | None | 219304 |
| 12509443 | April 30, 2045 | Drug product | None | 219304 |
Romvimza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 14, 2030 | 219304 |
Romvimza NDC codes
Questions
Is there a generic for Romvimza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Romvimza (vimseltinib). The Orange Book shows its last listed patent expires April 30, 2045 and its last listed exclusivity ends February 14, 2030.
What is the generic name for Romvimza?
The active ingredient in Romvimza is vimseltinib, per the FDA Orange Book.
When does the Romvimza patent expire?
The last patent listed for Romvimza in the Orange Book expires April 30, 2045. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.