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Last Updated: June 9, 2023

Details for New Drug Application (NDA): 209092

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NDA 209092 describes KISQALI, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight 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
Ingredient:ribociclib succinate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209092
Generic Entry Date for 209092*:
Constraining patent/regulatory exclusivity:

*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:Mar 13, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 10, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:Apr 14, 2036Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.