Generic entry timeline

Agamree generics — when can they launch?

Agamree (VAMOROLONE) · Catalyst Pharms · 7 active US patents · 0 expired

Earliest patent expiry
2029-05-28
3 years remaining
Full patent estate to
2040-07-16
complete protection through 2040
FDA approval
2023
Catalyst Pharms

Where Agamree sits in the generic timeline

Imminent generic cliff: earliest active US patent for Agamree expires in 2029 (~3 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

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.

  • Method of Use — 5 patents
  • Formulation — 1 patent
  • Composition of Matter — 1 patent

FDA U-codes carved out by Agamree 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-3747(no description)

Sample patent estate

Showing 6 of 7 active US patents. View full estate on the Agamree drug page →

  • US11833159 Formulation · expires 2029-05-28
    This patent protects compounds and methods for treating neuromuscular diseases, including muscular dystrophy, and inhibiting NF-κB.
    USPTO title: Non-hormonal steroid modulators of NF-kB for treatment of disease
  • US10857161 Method of Use · expires 2029-05-28
    This patent protects a pharmaceutical composition and methods for treating or reducing symptoms of muscular dystrophy using a specific compound.
    USPTO title: Non-hormonal steroid modulators of NF-kB for treatment of disease
  • US8334279 Method of Use · expires 2029-05-28
    This patent protects compounds and methods for treating or preventing muscular dystrophy and other muscular wasting diseases.
    USPTO title: Non-hormonal steroid modulators of NF-κB for treatment of disease
  • US11690853 Method of Use · expires 2033-03-07
    This patent protects non-hormonal steroid modulators of NF-κβ for use in treating diseases.
    USPTO title: Non-hormonal steroid modulators of NF-κβ for treatment of disease
  • US11471471 Method of Use · expires 2040-03-17
    This patent protects an aqueous oral pharmaceutical suspension composition containing vamorolone Form I and methods for its preparation and use.
    USPTO title: Aqueous oral pharmaceutical suspension compositions
  • US12201639 Method of Use · expires 2040-03-17
    This patent protects an aqueous oral pharmaceutical suspension composition containing vamorolone Form I and methods for its preparation and use.
    USPTO title: Aqueous oral pharmaceutical suspension compositions

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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