Orange Book product · Brand (NDA)

BENDEKA

BENDAMUSTINE HYDROCHLORIDE

Brand (NDA)NDA 208194RX EAGLE PHARMS

View BENDAMUSTINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Dec 07, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 07, 2015
10 yr 8 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-1972) 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 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-1971) 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 8609707 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 10052385 expires
Listed method-of-use patent (U-1972) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 10052385 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9000021 expires
Listed method-of-use patent (U-1542) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9034908 expires
Listed method-of-use patent (U-1542) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9144568 expires
Listed method-of-use patent (U-1542) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9572887 expires
Listed method-of-use patent (U-1972) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9572887 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9579384 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9579384 expires
Listed method-of-use patent (U-1972) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9597397 expires
Listed method-of-use patent (U-1972) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9597397 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9597398 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9597399 expires
Listed method-of-use patent (U-1972) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 9597399 expires
Listed method-of-use patent (U-1971) expiration.
Mar 15, 2033
in 6 yr 10 mo

Pharmaceutical detail

Active ingredient

BENDAMUSTINE HYDROCHLORIDE

Strength

100MG/4ML (25MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208194

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (32)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8791270	Jan 12, 2026	5 mo ago	ProductU-1790
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-1972
11844783	Jan 28, 2031	in 4 yr 8 mo	U-1971
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-1972
9572796	Jan 28, 2031	in 4 yr 8 mo	ProductU-1971
9572797	Jan 28, 2031	in 4 yr 8 mo	U-1971
9572797	Jan 28, 2031	in 4 yr 8 mo	U-1972
8609707	Aug 11, 2031	in 5 yr 3 mo	ProductU-1542
10052385	Mar 15, 2033	in 6 yr 10 mo	U-1972
10052385	Mar 15, 2033	in 6 yr 10 mo	U-1971
9000021	Mar 15, 2033	in 6 yr 10 mo	U-1542
9034908	Mar 15, 2033	in 6 yr 10 mo	U-1542
9144568	Mar 15, 2033	in 6 yr 10 mo	U-1542
9572887	Mar 15, 2033	in 6 yr 10 mo	U-1972
9572887	Mar 15, 2033	in 6 yr 10 mo	U-1971
9579384	Mar 15, 2033	in 6 yr 10 mo	U-1971
9579384	Mar 15, 2033	in 6 yr 10 mo	U-1972
9597397	Mar 15, 2033	in 6 yr 10 mo	U-1972
9597397	Mar 15, 2033	in 6 yr 10 mo	U-1971
9597398	Mar 15, 2033	in 6 yr 10 mo	U-1971
9597399	Mar 15, 2033	in 6 yr 10 mo	U-1972
9597399	Mar 15, 2033	in 6 yr 10 mo	U-1971

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