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Details for Patent: 8,163,904

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Patent 8,163,904 protects TASIGNA and is included in one NDA. There has been one Paragraph IV challenge on Tasigna.

This patent has forty-four patent family members in thirty-two countries.

Summary for Patent: 8,163,904

Title:Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Abstract: Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]- -3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide are prepared by various processes.
Inventor(s): Manley; Paul W (Arlesheim, CH), Shieh; Wen-Chung (Berkeley Heights, NJ), Sutton; Paul Allen (Parsippany, NJ), Karpinski; Piotr H (Lincoln Park, NJ), Wu; Raeann (Pine Brook, NJ), Monnier; Stephanie (Raedersheim, FR), Brozio; Jorg (Basel, CH)
Assignee: Novartis AG (Basel, CH) Novartis Pharma GmbH (Vienna, AT)
Application Number:11/995,898
Patent Claim Types:
see list of patent claims
Compound; Use; Formulation; Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Organic fine chemistry
Back Citations: 5th percentile
Forward Citations: 4th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-002Jun 17, 2010RXNo8,163,904► subscribeYY
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYes8,163,904► subscribeYY
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Foreign Priority and PCT Information for Patent: 8,163,904

PCT Information
PCT FiledJuly 18, 2006PCT Application Number:PCT/US2006/027878
PCT Publication Date:February 08, 2007PCT Publication Number: WO2007/015871

Non-Orange Book Patents for Patent: 8,163,904

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
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
8,389,537Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide► 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 Patent: 8,163,904

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina057467► subscribe
Austria514689► subscribe
Australia2006276205► 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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