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Last Updated: May 26, 2022

TREANDA Drug Patent 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.

DrugPatentWatch® 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.

Indicators of Generic Entry

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Drug patent expirations by year for TREANDA
Drug Prices for TREANDA

See drug prices for TREANDA

DrugPatentWatch® Estimated 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
Incyte CorporationPhase 3
Loxo Oncology, Inc.Phase 3
University Health Network, TorontoPhase 2

See all TREANDA clinical trials

Paragraph IV (Patent) Challenges for TREANDA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TREANDA Injection bendamustine hydrochloride 90 mg/mL, 0.5 mL and 2 mL in single- dose vials 022249 1 2014-06-19
TREANDA Injection bendamustine hydrochloride 25 mg/vial and 100 mg/vial 022249 10 2013-06-04

US Patents and Regulatory Information for TREANDA

TREANDA is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TREANDA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TREANDA

Bendamustine pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid forms of bendamustine hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Solid forms of bendamustine hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-001 Mar 20, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon TREANDA bendamustine hydrochloride SOLUTION;IV (INFUSION) 022249-004 Sep 13, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon TREANDA bendamustine hydrochloride POWDER;IV (INFUSION) 022249-002 May 1, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TREANDA

When does loss-of-exclusivity occur for TREANDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09296734
Estimated Expiration: See Plans and Pricing

Patent: 15207940
Estimated Expiration: See Plans and Pricing

Patent: 16203246
Estimated Expiration: See Plans and Pricing

Patent: 16247123
Estimated Expiration: See Plans and Pricing

Patent: 18202107
Estimated Expiration: See Plans and Pricing

Canada

Patent: 35899
Estimated Expiration: See Plans and Pricing

China

Patent: 2164579
Estimated Expiration: See Plans and Pricing

Patent: 4224703
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 26306
Estimated Expiration: See Plans and Pricing

Patent: 89029
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 11462
Estimated Expiration: See Plans and Pricing

Japan

Patent: 70335
Estimated Expiration: See Plans and Pricing

Patent: 12503666
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11002936
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TREANDA around the world.

Country Patent Number Title Estimated Expiration
South Korea 20170096221 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) See Plans and Pricing
Australia 2015207940 Liquid Formulations of Bendamustine See Plans and Pricing
Japan 2008526991 See Plans and Pricing
South Korea 20160098530 동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.