Bendamustine hydrochloride - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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

Bendamustine hydrochloride is the generic ingredient in three branded drugs marketed by Cephalon and Eagle Pharms, and is included in three 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 patent family members in thirty-two countries.

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

Summary for bendamustine hydrochloride

International Patents:	130
US Patents:	25
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	337
Patent Applications:	3,448
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
Kite, A Gilead Company	Phase 3
Fondazione Italiana Linfomi ONLUS	Phase 1/Phase 2
Roche S.p.a	Phase 1/Phase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for bendamustine hydrochloride

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try it Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	022249-004	Sep 13, 2013		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing			Y	See Plans and Pricing
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	205580-001	May 15, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for bendamustine hydrochloride

Subscribe to access the full database, or Try it Free
Country	Patent Number	Title	Estimated Expiration
Japan	6738376		See Plans and Pricing
Singapore	158870	BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION	See Plans and Pricing
Croatia	P20210915		See Plans and Pricing
Serbia	55491	FORMULACIJE BENDAMUSTINA (FORMULATIONS OF BENDAMUSTINE)	See Plans and Pricing
Argentina	072777	FORMAS SOLIDAS DE CLORHIDRATO DE BENDAMUSTINA	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.