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Details for Patent: 8,163,904

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Which drugs does patent 8,163,904 protect, and when does it expire?

Patent 8,163,904 protects TASIGNA and is included in one NDA.

Protection for TASIGNA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-nine patent family members in thirty-three 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;

Drugs Protected by US Patent 8,163,904

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No			Y	Y
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride monohydrate	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,163,904

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

Non-Orange Book US Patents Family Members 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
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
8,389,537	Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
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

International Family Members for US Patent 8,163,904

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Russian Federation	2013101749
Russian Federation	2509767
Russian Federation	2483065
Russian Federation	2011120363