➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Colorcon
Baxter
Mallinckrodt
McKesson

Last Updated: October 24, 2020

DrugPatentWatch Database Preview

Bendamustine hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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-four 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 eighteen 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 ten tentative approvals for this compound.

Recent Clinical Trials for bendamustine hydrochloride

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

SponsorPhase
Tessa TherapeuticsPhase 1
University of Colorado, DenverPhase 2
University Health Network, TorontoPhase 2

See all bendamustine hydrochloride clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MG/VIALPOWDER;IV (INFUSION)
  Start Trial  Start Trial25MG/VIALPOWDER;IV (INFUSION)
  Start Trial  Start Trial100MG/VIALPOWDER;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 ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
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 SOLUTION;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04
TREANDA POWDER;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04

US Patents and Regulatory Information for bendamustine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;IV (INFUSION) 205580-001 May 15, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
Express Scripts
AstraZeneca
Moodys
Medtronic

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.