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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Daiichi Sankyo
UBS
US Department of Justice
Medtronic
Farmers Insurance
Deloitte
Boehringer Ingelheim

Generated: May 27, 2018

DrugPatentWatch Database Preview

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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

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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 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 ➤ Try a Free Trial
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 ➤ Try a Free Trial
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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent 8,163,904

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Russian Federation 2013101749 ➤ Try a Free Trial
Russian Federation 2509767 ➤ Try a Free Trial
Russian Federation 2483065 ➤ Try a Free Trial
Russian Federation 2011120363 ➤ Try a Free Trial
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Queensland Health
Covington
Mallinckrodt
US Army
Colorcon
UBS
McKinsey

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