Subutex generics — when can they launch?
Subutex (BUPRENORPHINE) · Purdue Pharma Lp · 79 active US patents · 0 expired
Where Subutex sits in the generic timeline
All listed Orange Book patents for Subutex 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 — 70 patents
- Formulation — 9 patents
FDA U-codes carved out by Subutex 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-3620 | (no description) |
U-3619 | (no description) |
U-2180 | (no description) |
U-2489 | (no description) |
U-2209 | (no description) |
U-2179 | (no description) |
U-2181 | (no description) |
U-2208 | (no description) |
U-2206 | (no description) |
U-2176 | (no description) |
U-2173 | (no description) |
U-2174 | (no description) |
U-3616 | (no description) |
U-3617 | (no description) |
U-3618 | (no description) |
U-4100 | (no description) |
U-3111 | (no description) |
Sample patent estate
Showing 6 of 79 active US patents. View full estate on the Subutex drug page →
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This patent protects a pre-formulation for opioid depot formulations that dissolves or disperses an opioid bioactive agent, such as Subutex, in a mixture of neutral diacyl lipids, phospholipids, and organic solvents.USPTO title: Opioid depot formulations
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This patent protects a pre-formulation for opioid depot formulations that dissolves or disperses an opioid bioactive agent, such as Subutex, in a mixture of neutral diacyl lipids, phospholipids, and organic solvents.USPTO title: Opioid depot formulations
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This patent protects a method of using pre-formulations that contain an opioid bioactive agent, such as Subutex, to form a liquid crystalline phase structure upon contact with an aqueous fluid.USPTO title: Opioid depot formulations
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This patent protects a pre-formulation for opioid depot formulations that dissolves or disperses an opioid bioactive agent, such as Subutex, in a mixture of neutral diacyl lipids, phospholipids, and organic solvents.USPTO title: Opioid depot formulations
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This patent protects a method of using pre-formulations that contain an opioid bioactive agent, such as Subutex, to form a liquid crystalline phase structure upon contact with an aqueous fluid.USPTO title: Opioid depot formulations
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This patent protects a method of using pre-formulations that contain an opioid bioactive agent, such as Subutex, to form a liquid crystalline phase structure upon contact with an aqueous fluid.USPTO title: Opioid depot formulations
Sources
- FDA Orange Book — patents listed against Subutex (NDA filed 1981)
- Subutex drug profile — full patent estate, indications, clinical trials, pricing
- Purdue Pharma Lp 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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