Bendamustine hydrochloride - Generic Drug Details

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

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

Bendamustine hydrochloride has one hundred and thirty-four patent family members in thirty-two countries.

There are sixteen drug master file entries for bendamustine hydrochloride. Four suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for bendamustine hydrochloride

International Patents:	134
US Patents:	25
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	342
Patent Applications:	6,921
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bendamustine hydrochloride
What excipients (inactive ingredients) are in bendamustine hydrochloride?	bendamustine hydrochloride excipients list
DailyMed Link:	bendamustine hydrochloride at DailyMed

Recent Clinical Trials for bendamustine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Epizyme, Inc.	Phase 1/Phase 2
Vaishalee Kenkre	Phase 1/Phase 2
University of Wisconsin, Madison	Phase 1/Phase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG/VIAL	POWDER;IV (INFUSION)
		25MG/VIAL	POWDER;IV (INFUSION)
		100MG/VIAL	POWDER;IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bendamustine hydrochloride

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride

Antineoplastic Agents, Alkylating

Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELRAPZO	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	205580	1	2018-07-17
BENDEKA	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	208194	1	2017-05-04
TREANDA	Injection	bendamustine hydrochloride	90 mg/mL, 0.5 mL and 2 mL in single- dose vials	022249	1	2014-06-19
TREANDA	Injection	bendamustine hydrochloride	25 mg/vial and 100 mg/vial	022249	10	2013-06-04

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
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No

International Patents for bendamustine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1116073	BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION
Norway	20073722
Poland	2827863
World Intellectual Property Organization (WIPO)	2013142358