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Last Updated: August 14, 2020

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BENDEKA Drug 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 fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four 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.

US ANDA Litigation and Generic Entry Outlook for Bendeka

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 ten tentative approvals for the generic drug (bendamustine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for BENDEKA
Drug Prices for BENDEKA

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Recent Clinical Trials for BENDEKA

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SponsorPhase
Wake Forest University Health SciencesPhase 2
SanofiPhase 1/Phase 2
Washington University School of MedicinePhase 1/Phase 2

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Pharmacology for BENDEKA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for BENDEKA
Tradename Dosage Ingredient NDA Submissiondate
BENDEKA SOLUTION;IV (INFUSION) bendamustine hydrochloride 208194 2017-05-04

US Patents and Regulatory Information for BENDEKA

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   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;IV (INFUSION) 208194-001 Dec 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Medtronic
Merck
Johnson and Johnson
Boehringer Ingelheim

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