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Bendeka is a drug marketed by Eagle Pharms and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-six 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.
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.
There are twelve tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for BENDEKA
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||180|
|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|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for BENDEKA
*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
|Seattle Genetics, Inc.||Phase 2|
|Joseph Tuscano||Phase 2|
|German CLL Study Group||Phase 2|
|Country||Patent Number||Estimated Expiration|
|Japan||5726833||Get Started for $10|
|South Africa||200705793||Get Started for $10|
|Japan||2018070624||Get Started for $10|
|Denmark||2827863||Get Started for $10|
|World Intellectual Property Organization (WIPO)||2011094565||Get Started for $10|
|Lithuania||2827863||Get Started for $10|
|>Country||>Patent Number||>Estimated Expiration|