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FDA Orange Book · active-ingredient family

Letrozole; ribociclib succinate

Letrozole; ribociclib succinate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:KISQALI FEMARA CO-PACK (COPACKAGED) · NDA 209935

1

Brand (NDA)

0

Generics (ANDA)

22

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
KISQALI FEMARA CO-PACK (COPACKAGED)RLDNOVARTISNDA 209935—May 04, 2017

Marketing exclusivity (2)

  • I-951New indication exclusivity (3 years)

    Sep 17, 2027

    in 1 yr 3 mo

  • PEDPediatric exclusivity (adds 6 months)

    Mar 17, 2028

    in 1 yr 9 mo

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8324225Jun 17, 2028in 2 yr
SubstanceProduct
8324225*PEDDec 17, 2028in 2 yr 6 mo
9416136Aug 20, 2029in 3 yr 3 mo
U-2505
8962630Dec 09, 2029in 3 yr 6 mo
U-2505
9416136*PEDFeb 20, 2030in 3 yr 9 mo
8685980May 25, 2030in 4 yr
SubstanceProduct
8962630*PEDJun 09, 2030in 4 yr
8685980*PEDNov 25, 2030in 4 yr 6 mo
8415355Mar 13, 2031in 4 yr 10 mo
SubstanceProduct
8415355*PEDSep 13, 2031in 5 yr 4 mo
9868739Nov 09, 2031in 5 yr 6 mo
U-3998
9193732Nov 09, 2031in 5 yr 6 mo
SubstanceProduct
9193732*PEDMay 09, 2032in 6 yr
9868739*PEDMay 09, 2032in 6 yr
12544380Aug 07, 2034in 8 yr 3 mo
U-3264
12544380*PEDFeb 07, 2035in 8 yr 9 mo
12419894Apr 14, 2036in 10 yr
Product
10799506Apr 14, 2036in 10 yr
Product
12064434Apr 14, 2036in 10 yr
Product
10799506*PEDOct 14, 2036in 10 yr 6 mo
12064434*PEDOct 14, 2036in 10 yr 6 mo
12419894*PEDOct 14, 2036in 10 yr 6 mo

Letrozole; ribociclib succinate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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