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Details for Patent: 8,293,756

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Patent 8,293,756 protects TASIGNA and is included in one NDA. There has been one Paragraph IV challenge on Tasigna.

This patent has thirty-six patent family members in twenty-seven countries.

Summary for Patent: 8,293,756

Title:Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Abstract: A pharmaceutical composition, especially capsules, comprising granules containing nilotinib or a salt thereof with at least one pharmaceutically acceptable excipient. The granules may be produced by a wet granulation process.
Inventor(s): Bruneau; Nathalie (Cran-Gevrier, FR)
Assignee: Novartis AG (Basel, CH)
Application Number:12/442,544
Patent Claim Types:
see list of patent claims
Composition; Formulation; Process; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 7th percentile
Forward Citations: 1st 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, 2010RXNo8,293,756► subscribeY
Novartis
TASIGNA
nilotinib hydrochloride monohydrate
CAPSULE;ORAL022068-001Oct 29, 2007RXYes8,293,756► subscribeY
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Foreign Priority and PCT Information for Patent: 8,293,756

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
06121371Sep 27, 2006
PCT Information
PCT FiledSeptember 25, 2007PCT Application Number:PCT/EP2007/060165
PCT Publication Date:April 03, 2008PCT Publication Number: WO2008/037716

Non-Orange Book Patents for Patent: 8,293,756

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
8,501,760Pharmaceutical compositions comprising nilotinib or its salt► 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: 8,293,756

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2010504942► subscribe
Japan5567340► subscribe
Japan2014065715► 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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