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Last Updated: March 19, 2024

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. It is available from one supplier. There are eight 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. One supplier is listed for this compound. Additional details are available on the letrozole; ribociclib succinate profile page.
Summary for 209935
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209935
Generic Entry Date for 209935*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 209935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935 NDA Novartis Pharmaceuticals Corporation 0078-0909 0078-0909-61 1 KIT in 1 KIT (0078-0909-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 21 TABLET in 1 BLISTER PACK (0078-0888-21)
KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935 NDA Novartis Pharmaceuticals Corporation 0078-0916 0078-0916-61 1 KIT in 1 KIT (0078-0916-61) * 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0881-50) * 14 TABLET in 1 BLISTER PACK (0078-0895-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;EQ 200MG BASE
Approval Date:May 4, 2017TE:RLD:Yes
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?
Patent:⤷  Try a TrialPatent Expiration:Jun 17, 2028Product Flag?YSubstance Flag?YDelist 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.