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Last Updated: March 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209935

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NDA 209935 describes KISQALI FEMARA CO-PACK (COPACKAGED), which is a drug marketed by Novartis and is included in one NDA. There are seven 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 are twenty-four drug master file entries for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
Summary for 209935
Generic Entry Opportunity Date for 209935
Generic Entry Date for 209935*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, TABLET;ORALStrength2.5MG,N/A;N/A,EQ 200MG BASE
Approval Date:May 4, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 13, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jun 17, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Feb 19, 2031Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

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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.