ALBUTEROL SULFATE generics — when can they launch?
ALBUTEROL SULFATE (ALBUTEROL SULFATE) · · 5 active US patents · 0 expired
Where ALBUTEROL SULFATE sits in the generic timeline
All listed Orange Book patents for ALBUTEROL SULFATE 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
- Method of Use — 1 patent
FDA U-codes carved out by ALBUTEROL SULFATE 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-3509 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the ALBUTEROL SULFATE drug page →
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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 a holder with an elastomeric shaped part that is deformed to surround the component.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 is deformed to surround the component.USPTO title: Device for clamping a fluidic component
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This patent protects methods and systems for delivering two or more active agents through a metered dose inhaler for pulmonary or nasal use.USPTO title: Compositions, methods and systems for respiratory delivery of two or more active agents
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This patent protects an atomizer and method for dispensing and atomizing fluid into individual containers with improved dosing accuracy through a nozzle rinsing mechanism.USPTO title: Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Sources
- FDA Orange Book — patents listed against ALBUTEROL SULFATE (NDA filed 1982)
- ALBUTEROL SULFATE drug profile — full patent estate, indications, clinical trials, pricing
- 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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