Glycopyrrolate generics — when can they launch?
Glycopyrrolate (Glycopyrrolate) · Yonsei University · 18 active US patents · 0 expired
Where Glycopyrrolate sits in the generic timeline
All listed Orange Book patents for Glycopyrrolate 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 — 16 patents
- Method of Use — 2 patents
FDA U-codes carved out by Glycopyrrolate patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1773 | (no description) |
U-2941 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Glycopyrrolate drug page →
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This patent protects an inhalation therapy device that nebulizes a medicament, such as a fluid containing glycopyrrolate, into an aerosol for inhalation.USPTO title: Inhalation therapy device comprising an ampoule for storing a medicament to be nebulized
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This patent protects an inhaler device for powdered medicaments, specifically designed to hold a capsule and pierce it to release the medicament.USPTO title: Inhaler device
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This patent protects an inhaler device for powdered medicaments, specifically designed to hold a capsule and pierce it to release the medicament.USPTO title: Inhaler device
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This patent protects a dry powder composition made by co-jet milling particles for use in pulmonary inhalation.USPTO title: Dry powder composition comprising co-jet milled particles for pulmonary inhalation
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This patent protects a dry powder composition made by co-jet milling particles for use in pulmonary inhalation.USPTO title: Dry powder composition comprising co-jet milled particles for pulmonary inhalation
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This patent protects a disposable ampoule for use in an aerosol generating device that contains a medicament.USPTO title: Disposable ampoule for an aerosol generating device
Sources
- FDA Orange Book — patents listed against Glycopyrrolate (NDA)
- Glycopyrrolate drug profile — full patent estate, indications, clinical trials, pricing
- Yonsei University 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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