Generic entry timeline

Solosec generics — when can they launch?

Solosec (SECNIDAZOLE) · Evofem Inc · 11 active US patents · 0 expired

Earliest patent expiry
2035-09-04
9 years remaining
Full patent estate to
2041-12-11
complete protection through 2041
FDA approval
2017
Evofem Inc

Where Solosec sits in the generic timeline

Long-dated protection: earliest active US patent for Solosec extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 11 patents

FDA U-codes carved out by Solosec 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-3270(no description)
U-3169(no description)
U-2583(no description)
U-3302(no description)

Sample patent estate

Showing 6 of 11 active US patents. View full estate on the Solosec drug page →

  • US10849884 Method of Use · expires 2035-09-04
    This patent protects the use of secnidazole for the treatment of bacterial vaginosis.
    USPTO title: Secnidazole for use in the treatment of bacterial vaginosis
  • US11602522 Method of Use · expires 2035-09-04
    This patent protects a method of treating sexually transmitted infections by administering a therapeutically effective amount of secnidazole in a microgranule formulation.
    USPTO title: Secnidazole for use in the treatment of sexually transmitted infection
  • US10335390 Method of Use · expires 2035-09-04
    This patent protects the use of secnidazole for the treatment of bacterial vaginosis.
    USPTO title: Secnidazole for use in the treatment of bacterial vaginosis
  • US11000507 Method of Use · expires 2035-09-04
    This patent protects a method of treating bacterial vaginosis in a subject by administering a therapeutically effective amount of secnidazole in a microgranule formulation.
    USPTO title: Secnidazole for use in the treatment of bacterial vaginosis
  • US10682338 Method of Use · expires 2035-09-04
    This patent protects a method of treating bacterial vaginosis in a subject by administering a therapeutically effective amount of secnidazole in a microgranule formulation.
    USPTO title: Secnidazole for use in the treatment of bacterial vaginosis
  • US11324721 Method of Use · expires 2035-09-04
    This patent protects the use of secnidazole formulations for treating trichomoniasis in a subject in need of treatment.
    USPTO title: Secnidazole for use in the treatment of trichomoniasis

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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