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Serving leading biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
Deloitte
Boehringer Ingelheim
Moodys
QuintilesIMS
UBS
Cerilliant
Accenture
US Department of Justice

Generated: January 23, 2018

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 sixty 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 nilotinib hydrochloride monohydrate
Pharmacology for nilotinib hydrochloride monohydrate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for nilotinib hydrochloride monohydrate

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;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,580,806 Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide ➤ Subscribe
7,569,566 Inhibitors of tyrosine kinases ➤ Subscribe
9,163,005 Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide ➤ Subscribe
8,343,984 Crystalline 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
8,829,015 Crystalline 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
7,956,053 Inhibitors of tyrosine kinases ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for nilotinib hydrochloride monohydrate

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Deloitte
Argus Health
McKinsey
UBS
McKesson
US Department of Justice
Healthtrust

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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