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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Argus Health
Fish and Richardson
Merck
Colorcon
Healthtrust
Mallinckrodt
Covington
Citi

Generated: September 22, 2017

DrugPatentWatch Database Preview

Nilotinib hydrochloride monohydrate - Generic Drug Details

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What are the generic drug sources for nilotinib hydrochloride monohydrate and what is the scope of nilotinib hydrochloride monohydrate patent protection?

Nilotinib hydrochloride monohydrate
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nilotinib hydrochloride monohydrate has two hundred and thirty-two patent family members in fifty countries.

There are nine drug master file entries for nilotinib hydrochloride monohydrate. One supplier is listed for this compound.

Summary for Generic Name: nilotinib hydrochloride monohydrate

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list1
Bulk Api Vendors: see list18
Clinical Trials: see list2,504
Patent Applications: see list155
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nilotinib hydrochloride monohydrate at DailyMed

Pharmacology for Ingredient: nilotinib hydrochloride monohydrate

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;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeY ► 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;ORAL022068-001Oct 29, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: nilotinib hydrochloride monohydrate

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
8,580,806Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide► Subscribe
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
7,956,053Inhibitors of tyrosine kinases► 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
7,569,566Inhibitors 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 Ingredient: nilotinib hydrochloride monohydrate

Country Document Number Estimated Expiration
New Zealand537396► Subscribe
European Patent Office2368889► Subscribe
Canada2491632► Subscribe
Hong Kong1116783► Subscribe
European Patent Office2284167► Subscribe
Japan5129132► Subscribe
European Patent Office2284168► Subscribe
Hong Kong1169950► Subscribe
Israel197496► Subscribe
Hong Kong1160859► 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:

Cantor Fitzgerald
Fish and Richardson
Fuji
Cerilliant
Citi
US Department of Justice
Healthtrust
Boehringer Ingelheim
Moodys
AstraZeneca

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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