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Last Updated: October 25, 2021

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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 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 twenty-three patent family members in thirty-two countries.

There are twenty-three drug master file entries for bendamustine hydrochloride. Three suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Summary for bendamustine hydrochloride

International Patents:	123
US Patents:	25
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	319
Patent Applications:	1,540
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Czech Lymphoma Study Group	Phase 2
Tufts Medical Center	Phase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try it Free	⤷ Try it Free	100MG/VIAL	POWDER;IV (INFUSION)
⤷ Try it Free	⤷ Try it Free	25MG/VIAL	POWDER;IV (INFUSION)
⤷ Try it Free	⤷ Try it Free	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	NDA	Submissiondate
BELRAPZO	SOLUTION;IV (INFUSION)	bendamustine hydrochloride	205580	2018-07-17
BENDEKA	SOLUTION;IV (INFUSION)	bendamustine hydrochloride	208194	2017-05-04
TREANDA	SOLUTION;IV (INFUSION)	bendamustine hydrochloride	022249	2014-06-19
TREANDA	POWDER;IV (INFUSION)	bendamustine hydrochloride	022249	2014-06-19
TREANDA	POWDER;IV (INFUSION)	bendamustine hydrochloride	022249	2013-06-04
TREANDA	SOLUTION;IV (INFUSION)	bendamustine hydrochloride	022249	2013-06-04

US Patents and Regulatory Information for bendamustine hydrochloride

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Glossary

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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)	022249-002	May 1, 2009		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-001	Mar 20, 2008		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;IV (INFUSION)	022249-002	May 1, 2009		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ 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

International Patents for bendamustine hydrochloride

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Country	Patent Number	Estimated Expiration
Poland	2528602	⤷ Try it Free
South Korea	101918188	⤷ Try it Free
Portugal	2827863	⤷ Try it Free
Japan	5670335	⤷ Try it Free
Japan	2012503666	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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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.