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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 and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in forty-nine 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:	137
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	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes
Novartis	KISQALI FEMARA CO-PACK (COPACKAGED)	letrozole; ribociclib succinate	TABLET, TABLET;ORAL	209935-001	May 4, 2017		RX	Yes	Yes			Y	Y
Novartis	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	Patent Number	Estimated Expiration
Morocco	32555
Japan	5882371
Brazil	112013010167
Georgia, Republic of	P20115283
New Zealand	591176
Netherlands	300909

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331547	66/2017	Austria		PRODUCT NAME: RIBOCICLIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1221 (MITTEILUNG) 20170824
2331547	CR 2017 00060	Denmark		PRODUCT NAME: RIBOCICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/17/1221 20170824
2331547	2017059	Norway		PRODUCT NAME: RIBOSIKLIB ELLER ET; REG. NO/DATE: EU/1/17/1221 20170830
2331547	300909	Netherlands		PRODUCT NAME: RIBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/17/1221 20170824
2331547	LUC00048	Luxembourg		PRODUCT NAME: RIBOCICLIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/171221 20170824
2331547	PA2017039,C2331547	Lithuania		PRODUCT NAME: RIBOCIKLIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1221 20170822