Generic entry timeline

LANTHANUM CARBONATE generics — when can they launch?

LANTHANUM CARBONATE (LANTHANUM CARBONATE) · · 4 active US patents · 0 expired

Earliest patent expiry
2030-12-01
5 years remaining
Full patent estate to
2030-12-01
complete protection through 2030
FDA approval
2004
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Where LANTHANUM CARBONATE sits in the generic timeline

Mid-term cliff: earliest active US patent for LANTHANUM CARBONATE expires in 2030 (~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 — 4 patents

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the LANTHANUM CARBONATE drug page →

  • US9023397 Formulation · expires 2030-12-01
    This patent protects formulations of lanthanum carbonate or lanthanum carbonate hydrate in oral pharmaceutical capsules or powders.
    USPTO title: Capsule and powder formulations containing lanthanum compounds
  • US8980327 Formulation · expires 2030-12-01
    This patent protects formulations of lanthanum carbonate or lanthanum carbonate hydrate in oral pharmaceutical capsules or powders.
    USPTO title: Capsule and powder formulations containing lanthanum compounds
  • US8980327 Formulation · expires 2030-12-01
    This patent protects formulations of lanthanum carbonate or lanthanum carbonate hydrate in oral pharmaceutical capsules or powders.
    USPTO title: Capsule and powder formulations containing lanthanum compounds
  • US9023397 Formulation · expires 2030-12-01
    This patent protects formulations of lanthanum carbonate or lanthanum carbonate hydrate in oral pharmaceutical capsules or powders.
    USPTO title: Capsule and powder formulations containing lanthanum compounds

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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