Generic entry timeline

SOLIFENACIN SUCCINATE generics — when can they launch?

SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE) · · 1 active US patent · 0 expired

Earliest patent expiry
2031-05-18
5 years remaining
Full patent estate to
2031-05-18
complete protection through 2031
FDA approval
2004
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Where SOLIFENACIN SUCCINATE sits in the generic timeline

Mid-term cliff: earliest active US patent for SOLIFENACIN SUCCINATE expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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.

  • Formulation — 1 patent

Sample patent estate

Showing 1 of 1 active US patents. View full estate on the SOLIFENACIN SUCCINATE drug page →

  • US9918970 Formulation · expires 2031-05-18
    This patent protects a pharmaceutical composition that combines solifenacin or a salt thereof with an ion exchange resin and an acrylic based polymer.
    USPTO title: Pharmaceutical composition comprising solifenacin

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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