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Generated: November 14, 2018

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Details for New Drug Application (NDA): 209092

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NDA 209092 describes KISQALI, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the KISQALI profile page.

The generic ingredient in KISQALI 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 209092
Tradename:KISQALI
Applicant:Novartis Pharms Corp
Ingredient:ribociclib succinate
Patents:7
Generic Entry Opportunity Date for 209092
Generic Entry Date for 209092*:
Constraining patent/regulatory exclusivity:
Dosage:
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.

Pharmacology for NDA: 209092
Suppliers and Packaging for NDA: 209092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KISQALI ribociclib succinate TABLET;ORAL 209092 NDA Novartis Pharmaceuticals Corporation 0078-0860 0078-0860-01 1 BLISTER PACK in 1 CARTON (0078-0860-01) > 21 TABLET, FILM COATED in 1 BLISTER PACK
KISQALI ribociclib succinate TABLET;ORAL 209092 NDA Novartis Pharmaceuticals Corporation 0078-0867 0078-0867-42 3 BLISTER PACK in 1 CARTON (0078-0867-42) > 14 TABLET, FILM COATED in 1 BLISTER PACK (0078-0867-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Mar 13, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 18, 2021
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE RIBOCICLIB WITH AN AROMATASE INHIBITOR IN PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY
Regulatory Exclusivity Expiration:Mar 13, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 18, 2021
Regulatory Exclusivity Use:RIBOCICLIB WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY

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