FDA Orange Book
Generic for Treanda
Treanda 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
Yes. The generic name for Treanda is bendamustine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Treanda products the Orange Book lists.
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Treanda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | AP | 4 | AP |
| powder, intravenous | 25MG/VIAL | Marketed (Rx) | AP | 4 | AP |
| solution, intravenous | 180MG/2ML (90MG/ML) | Discontinued | None | 0 | None |
| solution, intravenous | 45MG/0.5ML (90MG/ML) | Discontinued | None | 0 | None |
NDA 022249, held by CEPHALON INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bendamustine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 205574 | AP (A-rated, therapeutically equivalent) | December 7, 2022 | 100MG/VIAL, 25MG/VIAL |
| DR REDDYS LABORATORIES LTD | 205376 | AP (A-rated, therapeutically equivalent) | December 7, 2022 | 100MG/VIAL, 25MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 214739 | AP (A-rated, therapeutically equivalent) | June 5, 2023 | 100MG/VIAL, 25MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 211001 | AP (A-rated, therapeutically equivalent) | June 5, 2023 | 100MG/VIAL, 25MG/VIAL |
Treanda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8791270 | January 12, 2026 | Drug product | U-1542 | 022249 |
| 8895756 | January 12, 2026 | Drug product | None | 022249 |
| 8609863 | January 12, 2026 | Drug product | None | 022249 |
| 8791270*PED | July 12, 2026 | Method of use | None | 022249 |
| 8609863*PED | July 12, 2026 | Method of use | None | 022249 |
| 8895756*PED | July 12, 2026 | Method of use | None | 022249 |
| 8445524 | March 26, 2029 | Drug substance, Drug product | U-1402 | 022249 |
| 9533955 | March 26, 2029 | Drug product | U-1952 | 022249 |
| 8669279 | March 26, 2029 | Drug product | U-1402 | 022249 |
| 9533955 | March 26, 2029 | Drug product | U-1949 | 022249 |
| 8883836 | March 26, 2029 | Drug product | U-1402 | 022249 |
| 8445524 | March 26, 2029 | Drug substance | None | 022249 |
| 8344006 | September 23, 2029 | Drug product | U-1402 | 022249 |
| 8445524*PED | September 26, 2029 | Method of use | None | 022249 |
| 8883836*PED | September 26, 2029 | Method of use | None | 022249 |
| 8669279*PED | September 26, 2029 | Method of use | None | 022249 |
| 9533955*PED | September 26, 2029 | Method of use | None | 022249 |
| 8344006*PED | March 23, 2030 | Method of use | None | 022249 |
| 8436190 | October 26, 2030 | Drug product | None | 022249 |
| 8436190*PED | April 26, 2031 | Method of use | None | 022249 |
Treanda NDC codes
Questions
Is there a generic for Treanda?
Yes. The generic name for Treanda is bendamustine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Treanda products the Orange Book lists.
What is the generic name for Treanda?
The active ingredient in Treanda is bendamustine, per the FDA Orange Book.
When does the Treanda patent expire?
The last patent listed for Treanda in the Orange Book expires April 26, 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.