Generic entry timeline

Daybue generics — when can they launch?

Daybue (TROFINETIDE) · Acadia Pharms Inc · 32 active US patents · 0 expired

Earliest patent expiry
2032-01-27
6 years remaining
Full patent estate to
2043-01-12
complete protection through 2043
FDA approval
2023
Acadia Pharms Inc

Where Daybue sits in the generic timeline

Mid-term cliff: earliest active US patent for Daybue expires in 2032 (~6 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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 — 16 patents
  • Method of Use — 12 patents
  • Composition of Matter — 4 patents

FDA U-codes carved out by Daybue patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-codeDescription
U-3556(no description)

Sample patent estate

Showing 6 of 32 active US patents. View full estate on the Daybue drug page →

  • US9212204 Method of Use · expires 2032-01-27
    This patent protects methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
  • US9212204 Method of Use · expires 2032-01-27
    This patent protects methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
  • US9212204 Method of Use · expires 2032-01-27
    This patent protects methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
  • US9212204 Method of Use · expires 2032-01-27
    This patent protects methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
  • US9212204 Other · expires 2032-07-27
    This patent protects compounds and methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
  • US9212204 Other · expires 2032-07-27
    This patent protects compounds and methods for treating Autism Spectrum Disorders, including Rett Syndrome, using glycyl-2-methylprolyl-glutamic acid and its analogs.
    USPTO title: Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid

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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