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Serving leading biopharmaceutical companies globally:

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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

Details for Patent: 8,389,537

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Which drugs does patent 8,389,537 protect, and when does it expire?

Patent 8,389,537 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 fifty-two patent family members in thirty-three countries.

Summary for Patent: 8,389,537
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)
Application Number:13/419,132
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 8,389,537

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

International Family Members for US Patent 8,389,537

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 057467   Start Trial
Austria 514689   Start Trial
Australia 2006276205   Start Trial
Australia 2010241419   Start Trial
Australia 2012203844   Start Trial
Brazil PI0613605   Start Trial
Canada 2615669   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Boehringer Ingelheim
Moodys
AstraZeneca
McKinsey

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