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Bendamustine hydrochloride - Generic Drug Details

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What are the generic drug sources for bendamustine hydrochloride and what is the scope of bendamustine hydrochloride patent protection?

Bendamustine hydrochloride is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Breckenridge Pharm, Glenmark Pharms Ltd, Mylan Labs Ltd, Cephalon, and Eagle Pharms, and is included in seven NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for bendamustine hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for bendamustine hydrochloride

US Patents:	24
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	22
Suppliers / Packagers:	3
Bulk Api Vendors:	84
Clinical Trials:	255
Patent Applications:	815
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bendamustine hydrochloride
DailyMed Link:	bendamustine hydrochloride at DailyMed

Pharmacology for bendamustine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride

Antineoplastic Agents, Alkylating

Tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	INJECTABLE; INJECTION

US Patents and Regulatory Information for bendamustine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y
Glenmark Pharms Ltd	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;IV (INFUSION)	204771-002	Mar 24, 2016	AP	RX	No	No
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y
Eagle Pharms	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes

International Patents for bendamustine hydrochloride

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	200701511
Australia	2016203246
China	104271135
China	104224703
China	102078305
Japan	6250628