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Last Updated: September 21, 2021

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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 Generic Entry Opportunity 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)
Paragraph IV (Patent) Challenges for 209935
Tradename Dosage Ingredient NDA Submissiondate
KISQALI FEMARA CO-PACK (COPACKAGED) TABLET;ORAL letrozole; ribociclib succinate 209935 2021-03-15

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:Mar 13, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Apr 14, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Jun 17, 2028Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

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