Generic entry timeline

NUSINERSEN SODIUM generics — when can they launch?

NUSINERSEN SODIUM (NUSINERSEN SODIUM) · · 7 active US patents · 0 expired

Earliest patent expiry
2027-07-11
1 year remaining
Full patent estate to
2036-03-04
complete protection through 2036
FDA approval
2016
—

Where NUSINERSEN SODIUM sits in the generic timeline

Imminent generic cliff: earliest active US patent for NUSINERSEN SODIUM expires in 2027 (~1 year 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
  • Composition of Matter — 2 patents

FDA U-codes carved out by NUSINERSEN SODIUM 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-1942(no description)
U-1941(no description)
U-1943(no description)
U-2094(no description)

Sample patent estate

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

  • US7838657 Composition of Matter · expires 2027-07-11
    This patent protects methods and compositions that block an inhibitory sequence in the SMN2 gene to modulate the splicing of pre-mRNA and elevate SMN protein expression.
    USPTO title: Spinal muscular atrophy (SMA) treatment via targeting of SMN2 splice site inhibitory sequences
  • US9717750 Method of Use · expires 2030-06-17
    This patent protects methods for modulating SMN2 splicing in a subject using compounds and compositions, including for the treatment of spinal muscular atrophy.
    USPTO title: Compositions and methods for modulation of SMN2 splicing in a subject
  • US8980853 Method of Use · expires 2030-11-24
    This patent protects methods for modulating SMN2 splicing in a subject using compounds and compositions, including for the treatment of spinal muscular atrophy.
    USPTO title: Compositions and methods for modulation of SMN2 splicing in a subject
  • US8361977 Composition of Matter · expires 2030-12-23
    This patent protects compounds and compositions that modulate the splicing of SMN2 mRNA in cells, tissues, or animals, and their use in treating diseases and disorders.
    USPTO title: Compositions and methods for modulation of SMN2 splicing
  • US9926559 Method of Use · expires 2034-01-09
    This patent protects methods for modulating SMN2 splicing in a subject using compounds and compositions, including for the treatment of spinal muscular atrophy.
    USPTO title: Compositions and methods for modulation of SMN2 splicing in a subject
  • US10436802 Method of Use · expires 2035-09-11
    This patent protects methods for treating spinal muscular atrophy by modulating the splicing of SMN2 mRNA in a subject.
    USPTO title: Methods for treating spinal muscular atrophy

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.

Get generic entry alerts

Free Pharma CI alerts on NUSINERSEN SODIUM — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.

Subscribe free →