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KISQALI FEMARA CO-PACK (COPACKAGED) Drug Profile

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Which patents cover Kisqali Femara Co-pack (copackaged), and what generic alternatives are available?

Kisqali Femara Co-pack (copackaged) is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and twenty-three patent family members in forty-eight countries.

The generic ingredient in KISQALI FEMARA CO-PACK (COPACKAGED) is letrozole; ribociclib succinate. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.

Summary for KISQALI FEMARA CO-PACK (COPACKAGED)

International Patents:	123
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
DailyMed Link:	KISQALI FEMARA CO-PACK (COPACKAGED) at DailyMed

Generic Entry Opportunity Date for KISQALI FEMARA CO-PACK (COPACKAGED)

NDA:

209935

Dosage:

TABLET, TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for KISQALI FEMARA CO-PACK (COPACKAGED)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis Pharms Corp	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y

International Patents for KISQALI FEMARA CO-PACK (COPACKAGED)

Country	Document Number	Estimated Expiration
Japan	2013091665
Brazil	112013010167
Dominican Republic	P2011000057
World Intellectual Property Organization (WIPO)	2007140222
Georgia, Republic of	P20135785

Supplementary Protection Certificates for KISQALI FEMARA CO-PACK (COPACKAGED)

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017000102	Germany		PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON.; REGISTRATION NO/DATE: EU/1/17/1221 20170822
0909	Netherlands		PRODUCT NAME: RIBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2017 00060	Denmark		PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
C0053	Belgium		PRODUCT NAME: LETROZOLE; NAT. REGISTRATION NO/DATE: 206 IS 241 F 3 19970616; FIRST REGISTRATION: FR 341 474.2 1996072
2017039	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822