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FDA Orange Book · active-ingredient family

Milsaperidone

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

Reference-listed drug:BYSANTI · NDA 220358

1

Brand (NDA)

0

Generics (ANDA)

10

Listed patents

7

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
BYSANTIRLD×7VANDA PHARMS INCNDA 220358—Feb 20, 2026

Marketing exclusivity (7)

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 20, 2031

    in 4 yr 9 mo

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10570453Mar 28, 2028in 1 yr 10 mo
U-4436
9157121Apr 05, 2030in 3 yr 10 mo
U-4436
10563259Jul 24, 2030in 4 yr 2 mo
U-4436
12606869Sep 22, 2030in 4 yr 4 mo
U-4506
8999638Oct 28, 2030in 4 yr 5 mo
U-4436
9074255Dec 17, 2030in 4 yr 7 mo
U-4436
9072742Jan 16, 2031in 4 yr 8 mo
U-4436
9074256Feb 10, 2031in 4 yr 9 mo
U-4436
9074254Dec 28, 2031in 5 yr 7 mo
U-4436
12478619May 31, 2044in 18 yr 3 mo
U-4434

Milsaperidone — 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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