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Last Updated: March 3, 2021

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TREANDA Drug Profile

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Which patents cover Treanda, and when can generic versions of Treanda launch?

Treanda is a drug marketed by Cephalon and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-seven patent family members in twenty-two countries.

The generic ingredient in TREANDA 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 Treanda

Treanda was eligible for patent challenges on March 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2030. This may change due to patent challenges or generic licensing.

There have been thirteen 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 eleven 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 TREANDA
Drug Prices for TREANDA

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Generic Entry Opportunity Date for TREANDA
Generic Entry Date for TREANDA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;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 TREANDA

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

SponsorPhase
AstraZenecaPhase 2
Sunnybrook Health Sciences CentrePhase 2
Joseph TuscanoPhase 2

See all TREANDA clinical trials

Pharmacology for TREANDA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for TREANDA
Tradename Dosage Ingredient NDA Submissiondate
TREANDA SOLUTION;IV (INFUSION) bendamustine hydrochloride 022249 2014-06-19
TREANDA POWDER;IV (INFUSION) bendamustine hydrochloride 022249 2014-06-19
TREANDA POWDER;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04
TREANDA SOLUTION;IV (INFUSION) bendamustine hydrochloride 022249 2013-06-04

US Patents and Regulatory Information for TREANDA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No   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
>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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