Details for Patent: 12,419,894

Which drugs does patent 12,419,894 protect, and when does it expire?

Patent 12,419,894 protects KISQALI and KISQALI FEMARA CO-PACK (COPACKAGED) and is included in two NDAs.

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

This patent has forty-seven patent family members in thirty countries.

Summary for Patent: 12,419,894

Title:	Ribociclib tablet
Abstract:	The present disclosure is directed to oral tablet of ribociclib including its salt(s). One embodiment of the present disclosure is directed to tablet of ribociclib with high drug load with an immediate release profile. One embodiment of the present disclosure is directed to coated tablet of ribociclib. Another embodiment of the present disclosure is directed to coated tablet of ribociclib where the coating is an aqueous moisture barrier coating (e.g., Opadry® amb II coating where the coating is PVA based).
Inventor(s):	Rui Costa, Arnaud Grandeury, Bindhumadhavan GURURAJAN
Assignee:	Novartis Pharmaceuticals Corp
Application Number:	US18/977,228
Patent Claim Types: see list of patent claims	Formulation; Dosage form;

Drugs Protected by US Patent 12,419,894

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	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes					Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes					Y

International Family Members for US Patent 12,419,894

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	104257
Australia	2016248017
Australia	2019201929
Australia	2020250190
Australia	2022215155
Australia	2024227794