Bendamustine
As of the edition of 20 October 2026, Bendamustine is a small molecule: marketed, first approved in 2008 (US); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Treanda
- First approved
- 20 March 2008 (US)
- Approvals on record
- 26 in 5 regions
- Holder of the most recent approval
- Avyxa; 11 holders in all
- Registered trials
- 325, 54 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Heart and blood vessels; Nervous system; Infections
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Teva.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 3 | 4 | 0 |
| Phase 1 | 70 | 38 | 18 | 14 |
| Phase 2 | 201 | 115 | 34 | 30 |
| Phase 3 | 43 | 21 | 7 | 10 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 325 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Teva | Originator and Lead sponsor of trials | 2003 to now |
| SymBio Pharmaceuticals | Applicant and Lead sponsor of trials | 2006 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2012 to now |
| Eagle Pharmaceuticals | Later holder | 2015 to now |
| Apotex | Later holder | 2022 to now |
| Baxter Healthcare | Later holder | 2022 to now |
| Azurity Pharmaceuticals | Acquired holder | 2024 to now |
| Dr. Reddy's | Later holder | 2025 to now |
| Avyxa | Acquired holder | 2026 to now |