Assyro AI

FDA Orange Book · active-ingredient family

Quizartinib dihydrochloride

Quizartinib dihydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VANFLYTA · NDA 216993

1

Brand (NDA)

0

Generics (ANDA)

11

Listed patents

4

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
VANFLYTARLD×2DAIICHI SANKYO INCNDA 216993—Jul 20, 2023

Marketing exclusivity (4)

  • NCENew chemical entity exclusivity (5 years)

    Jul 20, 2028

    in 2 yr 1 mo

  • ODE-437Orphan-drug exclusivity (7 years)

    Jul 20, 2030

    in 4 yr 2 mo

  • NCENew chemical entity exclusivity (5 years)

    Jul 20, 2028

    in 2 yr 1 mo

  • ODE-437Orphan-drug exclusivity (7 years)

    Jul 20, 2030

    in 4 yr 2 mo

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9585892Mar 16, 2027in 9 mo
U-3661
8129374Mar 16, 2027in 9 mo
U-3661
8883783Mar 16, 2027in 9 mo
Substance
8557810Mar 16, 2027in 9 mo
Product
7820657Sep 26, 2028in 2 yr 4 mo
Substance
7968543Aug 15, 2029in 3 yr 2 mo
ProductU-3661
8865710Aug 15, 2029in 3 yr 2 mo
Product
8836218Mar 23, 2030in 3 yr 10 mo
U-3661
9555040May 14, 2030in 4 yr
U-3661
8357690Feb 26, 2031in 4 yr 9 mo
U-3661
9675549Sep 30, 2033in 7 yr 5 mo
Product

Quizartinib dihydrochloride — 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.

Book a Demo