Spiriva generics — when can they launch?
Spiriva (TIOTROPIUM BROMIDE) · Boehringer Ingelheim · 9 active US patents · 1 expired
Where Spiriva sits in the generic timeline
All listed Orange Book patents for Spiriva 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.
- Other — 5 patents
- Formulation — 4 patents
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Spiriva drug page →
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This patent protects a method for administering an inhalable powder containing tiotropium, a specific type of medication, using an inhaler with a certain flow resistance.USPTO title: Method for the administration of an anticholinergic by inhalation
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This patent protects a locking-stressing-mechanism with a spring-actuated output drive device used in a two-part housing.USPTO title: Blocking device for a locking stressing mechanism having a spring-actuated output drive device
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This patent protects a device for clamping a fluidic component in an elastomeric shaped part.USPTO title: Device for clamping a fluidic component
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This patent protects a locking-stressing-mechanism with a spring-actuated output drive device and a counter that can be blocked after a certain number of actuations.USPTO title: Blocking device for a locking stressing mechanism having a spring-actuated output drive device
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This patent protects a device for clamping a fluidic component in a holder with an elastomeric shaped part that is deformed under internal tension.USPTO title: Device for clamping a fluidic component
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This patent protects a device for clamping a fluidic component in a holder with an elastomeric shaped part that surrounds the component.USPTO title: Device for clamping a fluidic component
Sources
- FDA Orange Book — patents listed against Spiriva (NDA filed 2004)
- Spiriva drug profile — full patent estate, indications, clinical trials, pricing
- Boehringer Ingelheim patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
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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