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Last Updated: May 25, 2022

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 ninety-eight 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. Three suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Bendeka

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2026. This may change due to patent challenges or generic licensing.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BENDEKA
Drug Prices for BENDEKA

See drug prices for BENDEKA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BENDEKA
Generic Entry Date for BENDEKA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BENDEKA

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

SponsorPhase
Incyte CorporationPhase 3
Tessa TherapeuticsPhase 2
Joseph TuscanoPhase 2

See all BENDEKA clinical trials

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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BENDEKA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting BENDEKA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Bendamustine pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Formulations of bendamustine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

FDA Regulatory Exclusivity protecting BENDEKA

TREATMENT OF PATIENTS WITH CLL AND TREATMENT OF PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
Exclusivity Expiration: 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
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 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
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
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 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
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
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
>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: See Plans and Pricing

Australia

Patent: 06204817
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0606332
Estimated Expiration: See Plans and Pricing

Canada

Patent: 93582
Estimated Expiration: See Plans and Pricing

China

Patent: 1119708
Estimated Expiration: See Plans and Pricing

Patent: 2078305
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3324
Estimated Expiration: See Plans and Pricing

Patent: 0701511
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63452
Estimated Expiration: See Plans and Pricing

Patent: 74334
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 16073
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4394
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88195
Estimated Expiration: See Plans and Pricing

Patent: 26833
Estimated Expiration: See Plans and Pricing

Patent: 08526991
Estimated Expiration: See Plans and Pricing

Patent: 13056901
Estimated Expiration: See Plans and Pricing

Patent: 13056902
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7661
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07008562
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6435
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3659
Estimated Expiration: See Plans and Pricing

Patent: 073722
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 8870
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0705793
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1648495
Estimated Expiration: See Plans and Pricing

Patent: 1918188
Estimated Expiration: See Plans and Pricing

Patent: 070094848
Estimated Expiration: See Plans and Pricing

Patent: 160098530
Estimated Expiration: See Plans and Pricing

Patent: 170096221
Estimated Expiration: See Plans and Pricing

Patent: 180056804
Estimated Expiration: See Plans and Pricing

Spain

Patent: 05611
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 80830
Estimated Expiration: See Plans and Pricing

Patent: 0637614
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 036
Estimated Expiration: See Plans and Pricing

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.

Country Patent Number Title Estimated Expiration
European Patent Office 3895694 FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE) See Plans and Pricing
Malaysia 157661 BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013142359 See Plans and Pricing
Norway 20073722 See Plans and Pricing
Poland 2528602 See Plans and Pricing
Eurasian Patent Organization 013324 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ БЕНДАМУСТИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛИОФИЛИЗАЦИИ (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILIZATION) See Plans and Pricing
Japan 2022028813 低減された投与容量を必要とする患者におけるベンダムスチン応答性症状の治療方法 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Medtronic
Merck
Johnson and Johnson
Boehringer Ingelheim

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.