Orange Book product · Brand (NDA)
TREANDA
BENDAMUSTINE HYDROCHLORIDE
At a glance
May 01, 2009
Approved
Brand (NDA)
Application
AP
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2009
17 yr 5 mo ago
Patent 8609863 expires
Listed drug product patent expiration.
Jan 12, 2026
5 mo ago
Patent 8791270 expires
Listed drug product patent expiration.
Jan 12, 2026
5 mo ago
Patent 8895756 expires
Listed drug product patent expiration.
Jan 12, 2026
5 mo ago
Today
Patent 8609863*PED expires
Listed listed patent expiration.
Jul 12, 2026
in 23 d
Patent 8791270*PED expires
Listed listed patent expiration.
Jul 12, 2026
in 23 d
Patent 8895756*PED expires
Listed listed patent expiration.
Jul 12, 2026
in 23 d
Patent 8445524 expires
Listed drug substance patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8669279 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8883836 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 9533955 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 9533955 expires
Listed drug product patent expiration.
Mar 26, 2029
in 2 yr 10 mo
Patent 8445524*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8669279*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8883836*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 9533955*PED expires
Listed listed patent expiration.
Sep 26, 2029
in 3 yr 4 mo
Patent 8436190 expires
Listed drug product patent expiration.
Oct 26, 2030
in 4 yr 5 mo
Patent 8436190*PED expires
Listed listed patent expiration.
Apr 26, 2031
in 4 yr 11 mo
Pharmaceutical detail
Active ingredient
BENDAMUSTINE HYDROCHLORIDE
Strength
25MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 022249
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 219014 · AVYXA HOLDINGS
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 216078 · BAXTER HLTHCARE CORP
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 211530 · HOSPIRA
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 215033 · APOTEX
- 2022VIVIMUSTABrand (NDA)
NDA 212209 · AZURITY
- 2018BELRAPZOBrand (NDA)
NDA 205580 · EAGLE PHARMS
- 2015BENDEKABrand (NDA)
NDA 208194 · EAGLE PHARMS
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206554 · NANG KUANG PHARM CO
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204230 · APOTEX
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214739 · EUGIA PHARMA
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211001 · MEITHEAL
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204104 · PHARMOBEDIENT
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8609863 | Jan 12, 2026 | 5 mo ago | Product |
| 8791270 | Jan 12, 2026 | 5 mo ago | ProductU-1542 |
| 8895756 | Jan 12, 2026 | 5 mo ago | Product |
| 8609863*PED | Jul 12, 2026 | in 23 d | |
| 8791270*PED | Jul 12, 2026 | in 23 d | |
| 8895756*PED | Jul 12, 2026 | in 23 d | |
| 8445524 | Mar 26, 2029 | in 2 yr 10 mo | SubstanceProductU-1402 |
| 8669279 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1402 |
| 8883836 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1402 |
| 9533955 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1952 |
| 9533955 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1949 |
| 8445524*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8669279*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8883836*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 9533955*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8436190 | Oct 26, 2030 | in 4 yr 5 mo | Product |
| 8436190*PED | Apr 26, 2031 | in 4 yr 11 mo |
