FDA Orange Book
Is there a generic for Vivimusta?
Vivimusta contains bendamustine. 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 Vivimusta (bendamustine). The Orange Book shows its last listed patent expires July 29, 2042.
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Vivimusta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG/4ML (25MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 212209, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vivimusta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12419867 | July 29, 2042 | Drug product | None | 212209 |
| 12208086 | July 29, 2042 | Drug product | None | 212209 |
| 11844784 | July 29, 2042 | Drug product | None | 212209 |
| 11707450 | July 29, 2042 | Drug product | None | 212209 |
Vivimusta NDC codes
Questions
Is there a generic for Vivimusta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vivimusta (bendamustine). The Orange Book shows its last listed patent expires July 29, 2042.
What is the generic name for Vivimusta?
The active ingredient in Vivimusta is bendamustine, per the FDA Orange Book.
When does the Vivimusta patent expire?
The last patent listed for Vivimusta in the Orange Book expires July 29, 2042. 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.