FDA Orange Book
Is there a generic for Bendeka?
Bendeka 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 Bendeka (bendamustine). The Orange Book shows its last listed patent expires March 15, 2033.
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Bendeka 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 208194, held by EAGLE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bendeka patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8791270 | January 12, 2026 | Drug product | U-1790 | 208194 |
| 9572797 | January 28, 2031 | Method of use | U-1971 | 208194 |
| 9572796 | January 28, 2031 | Drug product | U-1972 | 208194 |
| 9572797 | January 28, 2031 | Method of use | U-1972 | 208194 |
| 9572796 | January 28, 2031 | Drug product | U-1971 | 208194 |
| 12350257 | January 28, 2031 | Drug product | U-1542 | 208194 |
| 12350257 | January 28, 2031 | Drug product | U-1971 | 208194 |
| 12350257 | January 28, 2031 | Drug product | U-1972 | 208194 |
| 11103483 | January 28, 2031 | Drug product | U-1971 | 208194 |
| 11103483 | January 28, 2031 | Drug product | U-1972 | 208194 |
| 11844783 | January 28, 2031 | Method of use | U-1542 | 208194 |
| 11844783 | January 28, 2031 | Method of use | U-1972 | 208194 |
| 11844783 | January 28, 2031 | Method of use | U-1971 | 208194 |
| 11872214 | January 28, 2031 | Drug product | None | 208194 |
| 12138248 | January 28, 2031 | Drug product | None | 208194 |
| 10010533 | January 28, 2031 | Drug product | None | 208194 |
| 9265831 | January 28, 2031 | Drug product | None | 208194 |
| 8609707 | August 11, 2031 | Drug product | U-1542 | 208194 |
| 9144568 | March 15, 2033 | Method of use | U-1542 | 208194 |
| 10052385 | March 15, 2033 | Method of use | U-1972 | 208194 |
| 9597399 | March 15, 2033 | Method of use | U-1972 | 208194 |
| 9597399 | March 15, 2033 | Method of use | U-1971 | 208194 |
| 9034908 | March 15, 2033 | Method of use | U-1542 | 208194 |
| 10052385 | March 15, 2033 | Method of use | U-1971 | 208194 |
| 9597397 | March 15, 2033 | Method of use | U-1972 | 208194 |
| 9572887 | March 15, 2033 | Method of use | U-1972 | 208194 |
| 9572887 | March 15, 2033 | Method of use | U-1971 | 208194 |
| 9579384 | March 15, 2033 | Method of use | U-1971 | 208194 |
| 9579384 | March 15, 2033 | Method of use | U-1972 | 208194 |
| 9000021 | March 15, 2033 | Method of use | U-1542 | 208194 |
| 9597397 | March 15, 2033 | Method of use | U-1971 | 208194 |
| 9597398 | March 15, 2033 | Method of use | U-1971 | 208194 |
Bendeka NDC codes
Questions
Is there a generic for Bendeka?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bendeka (bendamustine). The Orange Book shows its last listed patent expires March 15, 2033.
What is the generic name for Bendeka?
The active ingredient in Bendeka is bendamustine, per the FDA Orange Book.
When does the Bendeka patent expire?
The last patent listed for Bendeka in the Orange Book expires March 15, 2033. 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.