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Bendamustine hydrochlorideis 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.
Summary for bendamustine hydrochloride
|Drug Master File Entries:||23|
|Suppliers / Packagers:||3|
|Bulk Api Vendors:||105|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for bendamustine hydrochloride|
|DailyMed Link:||bendamustine hydrochloride at DailyMed|
Recent Clinical Trials for bendamustine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Tessa Therapeutics||Phase 1|
|University of Colorado, Denver||Phase 2|
|University Health Network, Toronto||Phase 2|
Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE
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 Class||Alkylating Drug |
|Mechanism of Action||Alkylating Activity |
Medical Subject Heading (MeSH) Categories for bendamustine hydrochloride
Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE
|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|
|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|
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