Pulmicort Respules generics — when can they launch?
Pulmicort Respules (BUDESONIDE) · AstraZeneca K.K. · 37 active US patents · 0 expired
Where Pulmicort Respules sits in the generic timeline
All listed Orange Book patents for Pulmicort Respules 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.
- Method of Use — 24 patents
- Formulation — 13 patents
FDA U-codes carved out by Pulmicort Respules 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-3820 | (no description) |
U-3269 | (no description) |
U-2889 | (no description) |
U-3203 | (no description) |
U-1325 | (no description) |
U-2554 | (no description) |
U-3810 | (no description) |
U-4085 | (no description) |
Sample patent estate
Showing 6 of 37 active US patents. View full estate on the Pulmicort Respules drug page →
-
This patent protects methods and pharmaceutical compositions for preventing or alleviating symptoms and inflammation associated with gastrointestinal tract diseases.USPTO title: Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
-
This patent protects methods for preventing or alleviating symptoms and inflammation in the gastrointestinal tract, including the esophagus, using a pharmaceutical composition.USPTO title: Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
-
This patent protects methods for preventing or alleviating symptoms and inflammation in the gastrointestinal tract, including the esophagus, using a pharmaceutical composition.USPTO title: Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
-
This patent protects methods and pharmaceutical compositions for preventing or alleviating symptoms and inflammation in the gastrointestinal tract.USPTO title: Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
-
This patent protects methods and pharmaceutical compositions for preventing or alleviating symptoms and inflammation in the gastrointestinal tract.USPTO title: Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
-
This patent protects methods for preventing or alleviating symptoms and inflammation in the gastrointestinal tract, including the esophagus, using a pharmaceutical composition.USPTO title: Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
Sources
- FDA Orange Book — patents listed against Pulmicort Respules (NDA filed 1994)
- Pulmicort Respules drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca K.K. 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.
Get generic entry alerts
Free Pharma CI alerts on Pulmicort Respules — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →