Details for Patent: 8,389,537

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-three patent family members in thirty-four 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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,389,537
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	AB	RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010	AB	RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes					Y

International Family Members for US Patent 8,389,537

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	057467
Austria	E514689
Australia	2006276205
Australia	2010241419
Australia	2012203844
Brazil	PI0613605