Generic entry timeline

Amondys 45 generics — when can they launch?

Amondys 45 (CASIMERSEN) · Sarepta · 5 active US patents · 0 expired

Earliest patent expiry
2029-02-16
3 years remaining
Full patent estate to
2030-11-12
complete protection through 2030
FDA approval
2021
Sarepta

Where Amondys 45 sits in the generic timeline

Imminent generic cliff: earliest active US patent for Amondys 45 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 — 3 patents
  • Composition of Matter — 2 patents

FDA U-codes carved out by Amondys 45 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-3087(no description)
U-3089(no description)
U-3088(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the Amondys 45 drug page →

  • USRE48960 Method of Use · expires 2029-02-16
    This patent protects a method of using Amondys 45.
  • US10781450 Method of Use · expires 2030-11-12
    This patent protects a method of using an antisense molecule to induce exon skipping in the dystrophin gene.
    USPTO title: Antisense molecules and methods for treating pathologies
  • US9228187 Composition of Matter · expires 2030-11-12
    This patent protects antisense molecules that can bind to a specific target site in the dystrophin gene to induce exon skipping.
    USPTO title: Antisense molecules and methods for treating pathologies
  • US10287586 Composition of Matter · expires 2030-11-12
    This patent protects antisense molecules that can bind to a specific target site in the dystrophin gene to induce exon skipping.
    USPTO title: Antisense molecules and methods for treating pathologies
  • US9758783 Method of Use · expires 2030-11-12
    This patent protects a method of using antisense molecules to induce exon skipping in the dystrophin gene.
    USPTO title: Antisense molecules and methods for treating pathologies

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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