BENDAMUSTINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bendamustine hydrochloride and what is the scope of freedom to operate?

Bendamustine hydrochloride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Kindos, Mylan Labs Ltd, Nang Kuang Pharm Co, Cephalon, Eagle Pharms, Baxter Hlthcare Corp, Hospira, and Slayback Pharma Llc, and is included in fifteen NDAs. There are twenty-eight 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 forty-six patent family members in thirty-two countries.

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

Summary for BENDAMUSTINE HYDROCHLORIDE

International Patents:	146
US Patents:	28
Tradenames:	5
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	348
Patent Applications:	7,173
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
Philippe Armand, MD, PhD	Phase 2
Genmab	Phase 2
Cancer Research UK	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
Kindos	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;IV (INFUSION)	211001-001	Jun 5, 2023	AP	RX	No	No
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y
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	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y

International Patents for BENDAMUSTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3533447	COMPOSITIONS LIQUIDES DE BENDAMUSTINE POUR L'UTILISATION DANS LE TRAITEMENT DE MALADIES SENSIBLES À LA BENDAMUSTINE CHEZ DES PATIENTS NÉCESSITANT DES VOLUMES RÉDUITE POUR L'ADMINISTRATION (BENDAMUSTINE LIQUID COMPOSITIONS FOR USE IN METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION)
Mexico	2010010398	NUEVAS FORMAS SOLIDAS DE CLORHIDRATO DE BENDAMUSTINA. (NOVEL SOLID FORMS OF BENDAMUSTINE HYDROCHLORIDE.)
Taiwan	I380830
China	102078305	Bendamustine pharmaceutical compositions
Eurasian Patent Organization	200701511	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛИОФИЛИЗАЦИИ
European Patent Office	2326306	FORMULATIONS LIQUIDES DE BENDAMUSTINE (LIQUID FORMULATIONS OF BENDAMUSTINE)
Portugal	2827863