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TREANDA Drug Profile

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Which patents cover Treanda, and what substitute generic drugs 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-three 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. There is one tentative approval for this compound. Additional details are available on the bendamustine hydrochloride profile page.

Summary for Tradename: TREANDA

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list72
Clinical Trials: see list77
Patent Applications: see list302
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TREANDA at DailyMed

Pharmacology for Tradename: TREANDA

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009RXYesYes9,533,955► SubscribeY ► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-001Mar 20, 2008RXYesYes8,895,756*PED► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
SOLUTION;IV (INFUSION)022249-004Sep 13, 2013RXYesYes8,344,006*PED► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009RXYesYes8,791,270*PED► SubscribeY► Subscribe
Cephalon
TREANDA
bendamustine hydrochloride
POWDER;IV (INFUSION)022249-002May 1, 2009RXYesYes8,445,524*PED► SubscribeY► Subscribe
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Paragraph IV activity 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
Japan2011515472► Subscribe
Canada2718939► Subscribe
TaiwanI472515► Subscribe
European Patent Office1863452► 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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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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