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Serving leading biopharmaceutical companies globally:

UBS
Accenture
Fuji
Argus Health
Dow
Moodys
Chinese Patent Office
Express Scripts
Daiichi Sankyo
Novartis

Generated: December 13, 2017

DrugPatentWatch Database Preview

TREANDA Drug Profile

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When do Treanda patents expire, and what generic alternatives are available?

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 forty-eight patent family members in twenty-one countries.

The generic ingredient in TREANDA is bendamustine hydrochloride. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Drug patent expirations by year for TREANDA

Pharmacology for TREANDA

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Medical Subject Heading (MeSH) Categories for TREANDA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-002May 1, 2009APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochlorideSOLUTION;IV (INFUSION)022249-003Sep 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
CephalonTREANDAbendamustine hydrochloridePOWDER;IV (INFUSION)022249-001Mar 20, 2008APRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for TREANDA

Drugname Dosage Strength RLD Submissiondate
bendamustine hydrochlorideInjection90 mg/mL, 0.5 mL and 2 mL in single-dose vialsTreanda6/19/2014
bendamustine hydrochlorideInjection25 mg/vial and 100 mg/vialTreanda6/4/2013

Non-Orange Book Patents for Tradename: TREANDA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,461,350Bendamustine pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: TREANDA

Country Document Number Estimated Expiration
South Korea20070094848► Subscribe
Hong Kong1220966► Subscribe
Taiwan200944508► Subscribe
Mexico339878► Subscribe
TaiwanI380830► Subscribe
Eurasian Patent Organization013324► Subscribe
Ukraine94036► Subscribe
Spain2605205► Subscribe
European Patent Office2271315► Subscribe
Hong Kong1116073► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Boehringer Ingelheim
Argus Health
US Department of Justice
Queensland Health
Chubb
Federal Trade Commission
Julphar
Chinese Patent Office

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 verifification 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.

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