Orange Book product · Brand (NDA)
BELRAPZO
BENDAMUSTINE HYDROCHLORIDE
At a glance
May 15, 2018
Approved
Brand (NDA)
Application
AP
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 2018
8 yr 3 mo ago
Patent 8791270 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
Today
Patent 10010533 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11103483 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11103483 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11844783 expires
Listed method-of-use patent (U-1542) expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11844783 expires
Listed method-of-use patent (U-1971) expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11844783 expires
Listed method-of-use patent (U-1972) expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 11872214 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 12138248 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 12350257 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 12350257 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 12350257 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 9265831 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 9572796 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 9572796 expires
Listed drug product patent expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 9572797 expires
Listed method-of-use patent (U-1972) expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 9572797 expires
Listed method-of-use patent (U-1971) expiration.
Jan 28, 2031
in 4 yr 8 mo
Patent 8609707 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 8609707 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Pharmaceutical detail
Active ingredient
BENDAMUSTINE HYDROCHLORIDE
Strength
100MG/4ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 205580
Product number
001
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
- 2015BENDEKABrand (NDA)
NDA 208194 · EAGLE PHARMS
- 2009TREANDABrand (NDA)
NDA 022249 · CEPHALON
- 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 (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791270 | Jan 12, 2026 | 5 mo ago | ProductU-1971 |
| 8791270 | Jan 12, 2026 | 5 mo ago | ProductU-1972 |
| 10010533 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 11103483 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1971 |
| 11103483 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1972 |
| 11844783 | Jan 28, 2031 | in 4 yr 8 mo | U-1542 |
| 11844783 | Jan 28, 2031 | in 4 yr 8 mo | U-1971 |
| 11844783 | Jan 28, 2031 | in 4 yr 8 mo | U-1972 |
| 11872214 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 12138248 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 12350257 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1542 |
| 12350257 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1971 |
| 12350257 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1972 |
| 9265831 | Jan 28, 2031 | in 4 yr 8 mo | Product |
| 9572796 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1971 |
| 9572796 | Jan 28, 2031 | in 4 yr 8 mo | ProductU-1972 |
| 9572797 | Jan 28, 2031 | in 4 yr 8 mo | U-1972 |
| 9572797 | Jan 28, 2031 | in 4 yr 8 mo | U-1971 |
| 8609707 | Aug 11, 2031 | in 5 yr 3 mo | ProductU-1971 |
| 8609707 | Aug 11, 2031 | in 5 yr 3 mo | ProductU-1972 |
