Naloxone Hydrochloride generics — when can they launch?
Naloxone Hydrochloride (Naloxone Hydrochloride) · Pfizer Inc. · 57 active US patents · 4 expired
Where Naloxone Hydrochloride sits in the generic timeline
All listed Orange Book patents for Naloxone 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 — 34 patents
- Method of Use — 23 patents
FDA U-codes carved out by Naloxone Hydrochloride 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-2092 | (no description) |
U-1907 | (no description) |
U-2476 | (no description) |
U-3671 | (no description) |
U-1925 | (no description) |
U-3110 | (no description) |
U-2500 | (no description) |
U-4397 | (no description) |
U-3515 | (no description) |
Sample patent estate
Showing 6 of 57 active US patents. View full estate on the Naloxone Hydrochloride drug page →
-
This patent protects an apparatus with a label that can be attached to a medicament delivery device, such as an injector.USPTO title: Devices, systems and methods for medicament delivery
-
This patent protects an apparatus with a label that can be attached to a medicament delivery device, such as an injector.USPTO title: Devices, systems and methods for medicament delivery
-
This patent protects a label for a medicament delivery device that includes a textual indicia and an electronic circuit system.USPTO title: Devices, systems and methods for medicament delivery
-
This patent protects a label for a medicament delivery device that includes a textual indicia and an electronic circuit system.USPTO title: Devices, systems and methods for medicament delivery
-
This patent protects devices, systems, and methods for medicament delivery, specifically involving a medical injector with an actuation lock and energy storage member.USPTO title: Devices, systems and methods for medicament delivery
-
This patent protects devices, systems, and methods for medicament delivery, specifically involving a medical injector with an actuation lock and energy storage member.USPTO title: Devices, systems and methods for medicament delivery
Sources
- FDA Orange Book — patents listed against Naloxone Hydrochloride (NDA)
- Naloxone Hydrochloride drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. 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 Naloxone Hydrochloride — 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 →