Generic entry timeline

Rexulti generics — when can they launch?

Rexulti (BREXPIPRAZOLE) · Otsuka · 46 active US patents · 24 expired

Earliest patent expiry
2026-10-12
expired
Full patent estate to
2033-04-12
complete protection through 2033
FDA approval
2015
Otsuka

Where Rexulti sits in the generic timeline

All listed Orange Book patents for Rexulti have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

  • Other — 35 patents
  • Composition of Matter — 6 patents
  • Formulation — 5 patents

Sample patent estate

Showing 6 of 46 active US patents. View full estate on the Rexulti drug page →

  • US9839637 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders
  • US7888362 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders
  • US7888362 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders
  • US8618109 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders
  • US8618109 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders
  • US8349840 Other · expires 2026-10-12
    This patent protects a heterocyclic compound represented by the general formula (1) for treating mental disorders.
    USPTO title: Piperazine-substituted benzothiophenes for treatment of mental disorders

Sources

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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