Amoxil generics — when can they launch?
Amoxil (amoxicillin) · Generic (originally Beecham/GSK) · 14 active US patents · 0 expired
Where Amoxil sits in the generic timeline
Imminent generic cliff: earliest active US patent for Amoxil expires in 2026 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 8 patents
- Formulation — 4 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Amoxil 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-897 | (no description) |
U-1304 | (no description) |
U-2660 | (no description) |
U-3866 | (no description) |
U-3816 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the Amoxil drug page →
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This patent protects a modified release amoxicillin product that has a specific pharmacokinetic profile when taken with food.USPTO title: Modified release amoxicillin products
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This patent protects once-a-day penicillin-type antibiotic products that maintain effective levels in the serum for at least 5 hours within a 24-hour dosing interval.USPTO title: Compositions and methods for improved efficacy of penicillin-type antibiotics
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This patent protects a method of treating bacterial infections with a modified release antibiotic product administered once-a-day for a sufficient number of days.USPTO title: Pharmaceutical compositions and methods for improved bacterial eradication
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This patent protects a class of compounds, specifically 1-H-pyrrole derivatives, that inhibit acid secretion and have antiulcer activity.USPTO title: 1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors
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This patent protects a class of compounds, specifically 1-H-pyrrole derivatives, that inhibit acid secretion and have antiulcer activity.USPTO title: 1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors
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This patent protects a pharmaceutical composition or solid preparation containing a stabilized pharmaceutically active ingredient.USPTO title: Pharmaceutical composition
Sources
- FDA Orange Book — patents listed against Amoxil (NDA filed 1972)
- Amoxil drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Beecham/GSK) 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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