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FDA Orange Book · active-ingredient family

Valbenazine tosylate

Valbenazine tosylate is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INGREZZA SPRINKLE · NDA 218390

2

Brand (NDA)

2

Generics (ANDA)

22

Listed patents

9

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
INGREZZA SPRINKLERLD×3NEUROCRINENDA 218390—Apr 30, 2024
INGREZZARLD×3NEUROCRINENDA 209241ABApr 11, 2017

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
VALBENAZINE TOSYLATE×3ZYDUS LIFESCIENCESANDA 216137—Aug 07, 2024
VALBENAZINE TOSYLATE×2LUPINANDA 216064ABApr 05, 2024

Marketing exclusivity (9)

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

  • ODE-440Orphan-drug exclusivity (7 years)

    Aug 18, 2030

    in 4 yr 3 mo

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

  • ODE-440Orphan-drug exclusivity (7 years)

    Aug 18, 2030

    in 4 yr 3 mo

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

  • ODE-440Orphan-drug exclusivity (7 years)

    Aug 18, 2030

    in 4 yr 3 mo

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

  • I-925New indication exclusivity (3 years)

    Aug 18, 2026

    in 2 mo

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8357697Nov 08, 2027in 1 yr 5 mo
U-3055
8039627Apr 11, 2031in 4 yr 11 mo
SubstanceProduct
10844058Oct 28, 2036in 10 yr 6 mo
SubstanceProductU-1995
10851103Oct 28, 2036in 10 yr 6 mo
SubstanceProductU-1995
10851104Oct 28, 2036in 10 yr 6 mo
SubstanceU-1995
10065952Oct 28, 2036in 10 yr 6 mo
SubstanceProductU-1995
10906902Dec 22, 2036in 10 yr 8 mo
SubstanceProduct
10919892Dec 22, 2036in 10 yr 8 mo
SubstanceProduct
10906903Dec 22, 2036in 10 yr 8 mo
SubstanceProduct
10874648Oct 10, 2037in 11 yr 6 mo
U-1995
10857137Oct 10, 2037in 11 yr 6 mo
U-1995
10857148Oct 10, 2037in 11 yr 6 mo
U-1995
10952997Oct 10, 2037in 11 yr 6 mo
U-1995
11439629Oct 10, 2037in 11 yr 6 mo
U-3055
10912771Oct 10, 2037in 11 yr 6 mo
U-3055
10993941Oct 10, 2037in 11 yr 6 mo
U-1995
11040029Oct 10, 2037in 11 yr 6 mo
U-1995
11311532Sep 18, 2038in 12 yr 5 mo
ProductU-1995
11026939Sep 18, 2038in 12 yr 5 mo
ProductU-3055
11654142Nov 14, 2038in 12 yr 7 mo
U-3055
11026931Aug 14, 2039in 13 yr 4 mo
U-1995
10940141Aug 10, 2040in 14 yr 4 mo
U-1995

Valbenazine tosylate — 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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