Generic entry timeline

Exondys 51 generics — when can they launch?

Exondys 51 (ETEPLIRSEN) · Sarepta · 10 active US patents · 0 expired

Earliest patent expiry
2028-10-27
2 years remaining
Full patent estate to
2034-03-14
complete protection through 2034
FDA approval
2016
Sarepta

Where Exondys 51 sits in the generic timeline

Imminent generic cliff: earliest active US patent for Exondys 51 expires in 2028 (~2 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 — 8 patents
  • Formulation — 2 patents

FDA U-codes carved out by Exondys 51 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-2097(no description)
U-1918(no description)
U-1919(no description)

Sample patent estate

Showing 6 of 10 active US patents. View full estate on the Exondys 51 drug page →

  • USRE48468 Method of Use · expires 2028-10-27
    This patent protects a specific method of using Exondys 51.
  • USRE48468 Method of Use · expires 2028-10-27
    This patent protects a specific method of using Exondys 51.
  • USRE47769 Formulation · expires 2029-02-02
    This patent protects a specific formulation of a drug product.
  • USRE47769 Formulation · expires 2029-02-02
    This patent protects a specific formulation of a drug product.
  • US9506058 Method of Use · expires 2034-03-14
    This patent protects improved compositions and methods for treating muscular dystrophy using antisense molecules that induce exon skipping in the human dystrophin gene.
    USPTO title: Compositions for treating muscular dystrophy
  • US10364431 Method of Use · expires 2034-03-14
    This patent protects improved compositions and methods for treating muscular dystrophy using antisense molecules that induce exon skipping in the human dystrophin gene.
    USPTO title: Compositions for treating muscular dystrophy

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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