Details for New Drug Application (NDA): 209935

NDA 209935 describes KISQALI FEMARA CO-PACK (COPACKAGED), which is a drug marketed by Novartis and is included in one NDA. There are eleven patents protecting this drug. Additional details are available on the KISQALI FEMARA CO-PACK (COPACKAGED) profile page.

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

Summary for 209935

Tradename:	KISQALI FEMARA CO-PACK (COPACKAGED)
Applicant:	Novartis
Ingredient:	letrozole; ribociclib succinate
Patents:	11

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG;EQ 200MG BASE
Approval Date:	May 4, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 17, 2027
Regulatory Exclusivity Use:	FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2(HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Regulatory Exclusivity Expiration:	Mar 17, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:		Patent Expiration:	Oct 14, 2036	Product Flag?		Substance Flag?		Delist Request?	Y

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