FDA Orange Book
Is there a generic for Belrapzo?
Belrapzo 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 Belrapzo (bendamustine). The Orange Book shows its last listed patent expires August 11, 2031.
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Belrapzo 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) | AP | 0 | None |
NDA 205580, 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.
Belrapzo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8791270 | January 12, 2026 | Drug product | U-1971 | 205580 |
| 8791270 | January 12, 2026 | Drug product | U-1972 | 205580 |
| 9572796 | January 28, 2031 | Drug product | U-1971 | 205580 |
| 9572796 | January 28, 2031 | Drug product | U-1972 | 205580 |
| 9572797 | January 28, 2031 | Method of use | U-1972 | 205580 |
| 9572797 | January 28, 2031 | Method of use | U-1971 | 205580 |
| 11103483 | January 28, 2031 | Drug product | U-1971 | 205580 |
| 11103483 | January 28, 2031 | Drug product | U-1972 | 205580 |
| 12350257 | January 28, 2031 | Drug product | U-1542 | 205580 |
| 12350257 | January 28, 2031 | Drug product | U-1971 | 205580 |
| 12350257 | January 28, 2031 | Drug product | U-1972 | 205580 |
| 11844783 | January 28, 2031 | Method of use | U-1542 | 205580 |
| 11844783 | January 28, 2031 | Method of use | U-1971 | 205580 |
| 11844783 | January 28, 2031 | Method of use | U-1972 | 205580 |
| 10010533 | January 28, 2031 | Drug product | None | 205580 |
| 11872214 | January 28, 2031 | Drug product | None | 205580 |
| 12138248 | January 28, 2031 | Drug product | None | 205580 |
| 9265831 | January 28, 2031 | Drug product | None | 205580 |
| 8609707 | August 11, 2031 | Drug product | U-1971 | 205580 |
| 8609707 | August 11, 2031 | Drug product | U-1972 | 205580 |
Belrapzo NDC codes
Questions
Is there a generic for Belrapzo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Belrapzo (bendamustine). The Orange Book shows its last listed patent expires August 11, 2031.
What is the generic name for Belrapzo?
The active ingredient in Belrapzo is bendamustine, per the FDA Orange Book.
When does the Belrapzo patent expire?
The last patent listed for Belrapzo in the Orange Book expires August 11, 2031. 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.