Generic entry timeline

OLODATEROL HYDROCHLORIDE generics — when can they launch?

OLODATEROL HYDROCHLORIDE (OLODATEROL HYDROCHLORIDE) · · 8 active US patents · 0 expired

Earliest patent expiry
2026-10-10
expired
Full patent estate to
2030-10-16
complete protection through 2030
FDA approval
2014

Where OLODATEROL HYDROCHLORIDE sits in the generic timeline

All listed Orange Book patents for OLODATEROL HYDROCHLORIDE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

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
  • Composition of Matter — 2 patents
  • Other — 2 patents

Sample patent estate

Showing 6 of 8 active US patents. View full estate on the OLODATEROL HYDROCHLORIDE drug page →

  • US7396341 Formulation · expires 2026-10-10
    This patent protects a locking-stressing-mechanism with a spring-actuated output drive device.
    USPTO title: Blocking device for a locking stressing mechanism having a spring-actuated output drive device
  • US7727984 Composition of Matter · expires 2027-01-19
    This patent protects a pharmaceutical composition containing the compound olodaterol hydrochloride, used to treat chronic obstructive pulmonary disease.
    USPTO title: Medicaments for the treatment of chronic obstructive pulmonary disease
  • US7727984 Composition of Matter · expires 2027-01-19
    This patent protects a pharmaceutical composition containing the compound olodaterol hydrochloride, used to treat chronic obstructive pulmonary disease.
    USPTO title: Medicaments for the treatment of chronic obstructive pulmonary disease
  • US9027967 Formulation · expires 2027-03-31
    This patent protects a device for clamping a fluidic component in a holder using an elastomeric shaped part.
    USPTO title: Device for clamping a fluidic component
  • US7396341 Other · expires 2027-04-10
    This patent protects a blocking device for a locking mechanism that uses a spring-actuated output drive device.
    USPTO title: Blocking device for a locking stressing mechanism having a spring-actuated output drive device
  • US7837235 Formulation · expires 2028-03-13
    This patent protects a device for clamping a fluidic component in a holder using an elastomeric shaped part.
    USPTO title: Device for clamping a fluidic component

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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