FDA Orange Book · active-ingredient family
Bendamustine hydrochloride
Bendamustine hydrochloride is approved as 8 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BENDAMUSTINE HYDROCHLORIDE · NDA 219014
8
Brand (NDA)
8
Generics (ANDA)
41
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDERLD | AVYXA HOLDINGS | NDA 219014 | — | Jul 03, 2025 | |
| BENDAMUSTINE HYDROCHLORIDERLD | BAXTER HLTHCARE CORP | NDA 216078 | AP | Dec 15, 2022 | |
| BENDAMUSTINE HYDROCHLORIDERLD×3 | HOSPIRA | NDA 211530 | — | Dec 15, 2022 | |
| BENDAMUSTINE HYDROCHLORIDERLD | APOTEX | NDA 215033 | AP | Dec 07, 2022 | |
| VIVIMUSTARLD | AZURITY | NDA 212209 | — | Dec 07, 2022 | |
| BELRAPZORLD | EAGLE PHARMS | NDA 205580 | AP | May 15, 2018 | |
| BENDEKARLD | EAGLE PHARMS | NDA 208194 | — | Dec 07, 2015 | |
| TREANDARLD×4 | CEPHALON | NDA 022249 | AP | May 01, 2009 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE×2 | NANG KUANG PHARM CO | ANDA 206554 | — | Jun 07, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | APOTEX | ANDA 204230 | — | Jun 05, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | EUGIA PHARMA | ANDA 214739 | AP | Jun 05, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | MEITHEAL | ANDA 211001 | AP | Jun 05, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | PHARMOBEDIENT | ANDA 204104 | — | Apr 28, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | BRECKENRIDGE | ANDA 205447 | — | Feb 14, 2023 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | ACCORD HLTHCARE | ANDA 205574 | AP | Dec 07, 2022 | |
| BENDAMUSTINE HYDROCHLORIDE×2 | DR REDDYS | ANDA 205376 | AP | Dec 07, 2022 |
Listed patents (41)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791270 | Jan 12, 2026 | 5 mo ago | ProductU-1542 |
| 8895756 | Jan 12, 2026 | 5 mo ago | Product |
| 8609863 | Jan 12, 2026 | 5 mo ago | Product |
| 8791270*PED | Jul 12, 2026 | in 23 d | |
| 8609863*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 |
| 9533955 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1952 |
| 8669279 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1402 |
| 8883836 | Mar 26, 2029 | in 2 yr 10 mo | ProductU-1402 |
| 8344006 | Sep 23, 2029 | in 3 yr 4 mo | ProductU-1402 |
| 8445524*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8883836*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8669279*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 9533955*PED | Sep 26, 2029 | in 3 yr 4 mo | |
| 8344006*PED | Mar 23, 2030 | in 3 yr 10 mo | |
| 8436190 | Oct 26, 2030 | in 4 yr 5 mo | Product |
| 9572796 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1971 |
| 9572797 | Jan 28, 2031 | in 4 yr 8 mo | U-1972 |
| 11103483 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1971 |
| 12350257 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1542 |
| 11844783 | Jan 28, 2031 | in 4 yr 8 mo | U-1542 |
| 10010533 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 11872214 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 12138248 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 9265831 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 8436190*PED | Apr 26, 2031 | in 4 yr 11 mo | |
| 8609707 | Aug 11, 2031 | in 5 yr 3 mo | ProductU-1971 |
| 9144568 | Mar 15, 2033 | in 6 yr 10 mo | U-1542 |
| 10052385 | Mar 15, 2033 | in 6 yr 10 mo | U-1972 |
| 9597399 | Mar 15, 2033 | in 6 yr 10 mo | U-1972 |
| 9034908 | Mar 15, 2033 | in 6 yr 10 mo | U-1542 |
| 9597397 | Mar 15, 2033 | in 6 yr 10 mo | U-1972 |
| 9572887 | Mar 15, 2033 | in 6 yr 10 mo | U-1972 |
| 9579384 | Mar 15, 2033 | in 6 yr 10 mo | U-1971 |
| 9000021 | Mar 15, 2033 | in 6 yr 10 mo | U-1542 |
| 9597398 | Mar 15, 2033 | in 6 yr 10 mo | U-1971 |
| 12419867 | Jul 29, 2042 | in 16 yr 4 mo | Product |
| 12208086 | Jul 29, 2042 | in 16 yr 4 mo | Product |
| 11844784 | Jul 29, 2042 | in 16 yr 4 mo | Product |
| 11707450 | Jul 29, 2042 | in 16 yr 4 mo | Product |
Bendamustine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
