Details for Patent: 12,629,369

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Which drugs does patent 12,629,369 protect, and when does it expire?

Patent 12,629,369 protects DANZITEN and is included in one NDA.

This patent has eight patent family members in five countries.

Summary for Patent: 12,629,369

Title:	Pharmaceutical compositions of nilotinib
Abstract:	Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
Inventor(s):	Paras P. JAIN, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. KORE, Sandeep Jain, Hanimi Reddy BAPATU
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US19/258,578
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Drugs Protected by US Patent 12,629,369

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-001	Nov 7, 2024		RX	Yes	Yes			Y
Azurity	DANZITEN	nilotinib tartrate	TABLET;ORAL	219293-002	Nov 7, 2024		RX	Yes	Yes			Y

International Family Members for US Patent 12,629,369

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	113573712
China	122351243
European Patent Office	3914252