Aldara generics — when can they launch?
Aldara (IMIQUIMOD) · Bausch Health · 10 active US patents · 0 expired
Where Aldara sits in the generic timeline
Imminent generic cliff: earliest active US patent for Aldara expires in 2029 (~3 years 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 — 10 patents
FDA U-codes carved out by Aldara 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-172 | (no description) |
U-68 | (no description) |
U-1455 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Aldara drug page →
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This patent protects lower dosage strength imiquimod formulations and shorter dosing regimens for treating genital and perianal warts.USPTO title: Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
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This patent protects methods for treating dermatological disorders and inducing interferon biosynthesis using shorter durations of imiquimod therapy.USPTO title: Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy
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This patent protects a 2x2x2 week dosing regimen for treating actinic keratosis with a 3.75% imiquimod pharmaceutical composition.USPTO title: 2Ã2Ã2 week dosing regimen for treating acting keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
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This patent protects a 2x2x2 week dosing regimen for treating actinic keratosis with a 3.75% imiquimod pharmaceutical composition.USPTO title: 2x2x2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75% imiquimod
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This patent protects a 2x2x2 week dosing regimen for treating actinic keratosis with a 3.75% imiquimod pharmaceutical composition.USPTO title: 2Ã2Ã2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod
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This patent protects a 2x2x2 week treatment regimen for treating actinic keratosis using a 2.5% imiquimod pharmaceutical composition.USPTO title: 2Ã2Ã2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod
Sources
- FDA Orange Book — patents listed against Aldara (NDA filed 1997)
- Aldara drug profile — full patent estate, indications, clinical trials, pricing
- Bausch Health patent portfolio
- Patent cliff 2029 — 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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