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Last Updated: September 25, 2023

BENDEKA Drug Patent Profile

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Which patents cover Bendeka, and what generic alternatives are available?

Bendeka is a drug marketed by Eagle Pharms and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ten patent family members in thirty-one countries.

The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bendeka

A generic version of BENDEKA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7^th, 2022.

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Summary for BENDEKA

International Patents:	110
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	21
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BENDEKA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENDEKA
What excipients (inactive ingredients) are in BENDEKA?	BENDEKA excipients list
DailyMed Link:	BENDEKA at DailyMed

Drug patent expirations by year for BENDEKA

Drug Prices for BENDEKA

Recent Clinical Trials for BENDEKA

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

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

See all BENDEKA clinical trials

Pharmacology for BENDEKA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for BENDEKA

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

Paragraph IV (Patent) Challenges for BENDEKA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENDEKA	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	208194	1	2017-05-04

US Patents and Regulatory Information for BENDEKA

BENDEKA is protected by twenty-four US patents.

Patents protecting BENDEKA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Bendamustine pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA

Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

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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
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;IV (INFUSION)	208194-001	Dec 7, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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 BENDEKA

When does loss-of-exclusivity occur for BENDEKA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2877
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 06204817
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0606332
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 93582
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1119708
Estimated Expiration: ⤷ Try a Trial

Patent: 2078305
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 3324
Estimated Expiration: ⤷ Try a Trial

Patent: 0701511
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 63452
Estimated Expiration: ⤷ Try a Trial

Patent: 74334
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 16073
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 88195
Estimated Expiration: ⤷ Try a Trial

Patent: 26833
Estimated Expiration: ⤷ Try a Trial

Patent: 08526991
Estimated Expiration: ⤷ Try a Trial

Patent: 13056901
Estimated Expiration: ⤷ Try a Trial

Patent: 13056902
Estimated Expiration: ⤷ Try a Trial

Malaysia

Patent: 7661
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 07008562
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 6435
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 3659
Estimated Expiration: ⤷ Try a Trial

Patent: 073722
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 8870
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 0705793
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1648495
Estimated Expiration: ⤷ Try a Trial

Patent: 1918188
Estimated Expiration: ⤷ Try a Trial

Patent: 070094848
Estimated Expiration: ⤷ Try a Trial

Patent: 160098530
Estimated Expiration: ⤷ Try a Trial

Patent: 170096221
Estimated Expiration: ⤷ Try a Trial

Patent: 180056804
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 05611
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 80830
Estimated Expiration: ⤷ Try a Trial

Patent: 0637614
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 036
Estimated Expiration: ⤷ Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BENDEKA around the world.

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Country	Patent Number	Title	Estimated Expiration
Hong Kong	1243346	在要求減少施用容量的患者中治療苯達莫司汀響應性狀況的方法 (METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION)	⤷ Try a Trial
Japan	6224064		⤷ Try a Trial
China	102078305	Bendamustine pharmaceutical compositions	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey

AstraZeneca

Medtronic

Merck

Johnson and Johnson

Boehringer Ingelheim

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