Generic entry timeline

Catapres-Tts-1 generics — when can they launch?

Catapres-Tts-1 (CLONIDINE) · Lavipharm · 4 active US patents · 0 expired

Earliest patent expiry
2027-04-17
1 year remaining
Full patent estate to
2031-09-08
complete protection through 2031
FDA approval
1974
Lavipharm

Where Catapres-Tts-1 sits in the generic timeline

Imminent generic cliff: earliest active US patent for Catapres-Tts-1 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.

  • Formulation — 4 patents

Sample patent estate

Showing 4 of 4 active US patents. View full estate on the Catapres-Tts-1 drug page →

  • US8337890 Formulation · expires 2027-04-17
    This patent protects modified release formulations containing a coated drug-ion exchange resin complex with a polyvinyl acetate polymer and plasticizer coating.
    USPTO title: Modified release formulations containing drug-ion exchange resin complexes
  • US8337890 Formulation · expires 2027-04-17
    This patent protects modified release formulations containing a coated drug-ion exchange resin complex with a polyvinyl acetate polymer and plasticizer coating.
    USPTO title: Modified release formulations containing drug-ion exchange resin complexes
  • US8623409 Formulation · expires 2031-09-08
    This patent protects a clonidine formulation that provides a 24-hour extended release profile with a single peak after a single dose administration.
    USPTO title: Clonidine formulation
  • US8623409 Formulation · expires 2031-09-08
    This patent protects a clonidine formulation that provides a 24-hour extended release profile with a single peak after a single dose administration.
    USPTO title: Clonidine formulation

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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