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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Julphar
Johnson and Johnson
US Army
Colorcon
US Department of Justice
Covington
Fish and Richardson
Daiichi Sankyo
Chubb

Generated: September 25, 2017

DrugPatentWatch Database Preview

TASIGNA Drug Profile

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

Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-two patent family members in fifty countries.

The generic ingredient in TASIGNA is nilotinib hydrochloride monohydrate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride monohydrate profile page.

Summary for Tradename: TASIGNA

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list101
Clinical Trials: see list52
Patent Applications: see list92
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TASIGNA at DailyMed

Pharmacology for Tradename: TASIGNA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV (Patent) Challenges for TASIGNA

Drugname Dosage Strength RLD Submissiondate
nilotinibCapsules150 mg and 200 mgTasigna1/29/2013

Non-Orange Book Patents for Tradename: TASIGNA

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
7,569,566Inhibitors of tyrosine kinases► Subscribe
8,829,015Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide► Subscribe
8,343,984Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide► Subscribe
9,163,005Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide► Subscribe
8,580,806Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide► Subscribe
7,956,053Inhibitors of tyrosine kinases► 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: TASIGNA

Country Document Number Estimated Expiration
Denmark2501384► Subscribe
Taiwan200800950► Subscribe
Slovenia1532138► Subscribe
Morocco29686► Subscribe
Australia2010241419► Subscribe
Morocco30807► Subscribe
New Zealand564409► Subscribe
Eurasian Patent Organization201000145► Subscribe
Honduras2008000311► Subscribe
CroatiaP20120573► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKinsey
Fuji
Medtronic
Boehringer Ingelheim
Cipla
Novartis
US Department of Justice
Baxter
Daiichi Sankyo
Colorcon

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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