Is there a generic for Bendamustine hydrochloride?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Bendamustine hydrochloride, referencing the brand BENDAMUSTINE HYDROCHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bendamustine hydrochloride?

BENDAMUSTINE HYDROCHLORIDE (NDA 219014, AVYXA HOLDINGS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bendamustine hydrochloride?

The Orange Book lists 41 patents against Bendamustine hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Bendamustine hydrochloride are approved?

Bendamustine hydrochloride is approved in the following dosage forms: powder, solution.

FDA Orange Book · active-ingredient family

Bendamustine hydrochloride

Bendamustine hydrochloride: 8 brands, 8 generics; first approved Mar 20, 2008; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 8 ANDA applications approved.

Earliest patent expiry Jan 12, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 12, 2026

7 mo ago

Brand (NDA) products

Originator applications

BENDAMUSTINE HYDROCHLORIDERLDRS
AVYXA HOLDINGSNDA 2190142025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx —
BENDAMUSTINE HYDROCHLORIDERLDRS
BAXTER HLTHCARE CORPNDA 2160782022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

BENDAMUSTINE HYDROCHLORIDERLD

HOSPIRANDA 21153020223 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/ML (25MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
200MG/8ML (25MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

BENDAMUSTINE HYDROCHLORIDERLDRS
APOTEXNDA 2150332022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx AP
VIVIMUSTARLDRS
AZURITYNDA 2122092022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx —
BELRAPZORLDRS
EAGLE PHARMSNDA 2055802018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx AP
BENDEKARLDRS
EAGLE PHARMSNDA 2081942015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/4ML (25MG/ML) SOLUTION INTRAVENOUS Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/4ML (25MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

TREANDARLDRS

CEPHALONNDA 02224920094 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
25MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
45MG/0.5ML (90MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
180MG/2ML (90MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

Generic (ANDA) products (8)

Abbreviated applications

BENDAMUSTINE HYDROCHLORIDE
NANG KUANG PHARM COANDA 20655420232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Discontinued —
100MG/VIAL POWDER INTRAVENOUS Discontinued —
BENDAMUSTINE HYDROCHLORIDE
APOTEXANDA 20423020232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Discontinued —
100MG/VIAL POWDER INTRAVENOUS Discontinued —
BENDAMUSTINE HYDROCHLORIDE
EUGIA PHARMAANDA 21473920232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Rx AP
100MG/VIAL POWDER INTRAVENOUS Rx AP
BENDAMUSTINE HYDROCHLORIDE
MEITHEALANDA 21100120232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Rx AP
100MG/VIAL POWDER INTRAVENOUS Rx AP
BENDAMUSTINE HYDROCHLORIDE
PHARMOBEDIENTANDA 20410420232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Discontinued —
100MG/VIAL POWDER INTRAVENOUS Discontinued —
BENDAMUSTINE HYDROCHLORIDE
BRECKENRIDGEANDA 20544720232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Discontinued —
100MG/VIAL POWDER INTRAVENOUS Discontinued —
BENDAMUSTINE HYDROCHLORIDE
ACCORD HLTHCAREANDA 20557420222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Rx AP
100MG/VIAL POWDER INTRAVENOUS Rx AP
BENDAMUSTINE HYDROCHLORIDE
DR REDDYSANDA 20537620222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG/VIAL POWDER INTRAVENOUS Rx AP
100MG/VIAL POWDER INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—
100MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—
100MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
100MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
100MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—
100MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—
100MG/VIAL	POWDER	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
100MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG/VIAL	POWDER	INTRAVENOUS	Rx	AP
100MG/VIAL	POWDER	INTRAVENOUS	Rx	AP

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8791270	Jan 12, 2026	7 mo ago	ProductU-1542
8895756	Jan 12, 2026	7 mo ago	Product
8609863	Jan 12, 2026	7 mo ago	Product
8791270*PED	Jul 12, 2026	1 mo ago
8609863*PED	Jul 12, 2026	1 mo ago
8895756*PED	Jul 12, 2026	1 mo ago
8445524	Mar 26, 2029	in 2 yr 8 mo	SubstanceProductU-1402
9533955	Mar 26, 2029	in 2 yr 8 mo	ProductU-1952
8669279	Mar 26, 2029	in 2 yr 8 mo	ProductU-1402
8883836	Mar 26, 2029	in 2 yr 8 mo	ProductU-1402
8344006	Sep 23, 2029	in 3 yr 2 mo	ProductU-1402
8445524*PED	Sep 26, 2029	in 3 yr 2 mo
8883836*PED	Sep 26, 2029	in 3 yr 2 mo
8669279*PED	Sep 26, 2029	in 3 yr 2 mo
9533955*PED	Sep 26, 2029	in 3 yr 2 mo
8344006*PED	Mar 23, 2030	in 3 yr 8 mo
8436190	Oct 26, 2030	in 4 yr 3 mo	Product
9572796	Jan 28, 2031	in 4 yr 6 mo	ProductU-1971
9572797	Jan 28, 2031	in 4 yr 6 mo	U-1972
11103483	Jan 28, 2031	in 4 yr 6 mo	ProductU-1971
12350257	Jan 28, 2031	in 4 yr 6 mo	ProductU-1542
11844783	Jan 28, 2031	in 4 yr 6 mo	U-1542
10010533	Jan 28, 2031	in 4 yr 6 mo	Product
11872214	Jan 28, 2031	in 4 yr 6 mo	Product
12138248	Jan 28, 2031	in 4 yr 6 mo	Product
9265831	Jan 28, 2031	in 4 yr 6 mo	Product
8436190*PED	Apr 26, 2031	in 4 yr 9 mo
8609707	Aug 11, 2031	in 5 yr 1 mo	ProductU-1971
9144568	Mar 15, 2033	in 6 yr 8 mo	U-1542
10052385	Mar 15, 2033	in 6 yr 8 mo	U-1972
9597399	Mar 15, 2033	in 6 yr 8 mo	U-1972
9034908	Mar 15, 2033	in 6 yr 8 mo	U-1542
9597397	Mar 15, 2033	in 6 yr 8 mo	U-1972
9572887	Mar 15, 2033	in 6 yr 8 mo	U-1972
9579384	Mar 15, 2033	in 6 yr 8 mo	U-1971
9000021	Mar 15, 2033	in 6 yr 8 mo	U-1542
9597398	Mar 15, 2033	in 6 yr 8 mo	U-1971
12419867	Jul 29, 2042	in 16 yr 2 mo	Product
12208086	Jul 29, 2042	in 16 yr 2 mo	Product
11844784	Jul 29, 2042	in 16 yr 2 mo	Product
11707450	Jul 29, 2042	in 16 yr 2 mo	Product

Approval history

FDA approval span

First approval

Mar 20, 2008

18 yr 8 mo ago

Most recent approval

Jul 03, 2025

1 yr 2 mo ago

Approvals span 2008–2025 across 16 FDA applications.

Brand (NDA) 850%

Generic (ANDA) 850%

Bendamustine hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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