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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.
Generic Entry Opportunity Date for 209935
*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:||RX||Dosage:||TABLET, TABLET;ORAL||Strength||2.5MG,N/A;N/A,EQ 200MG BASE|
|Approval Date:||May 4, 2017||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Mar 13, 2022|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||Start Trial||Patent Expiration:||Jun 17, 2028||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patent:||Start Trial||Patent Expiration:||Feb 19, 2031||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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