Azelex generics — when can they launch?
Azelex (AZELAIC ACID) · Leo Pharma As · 4 active US patents · 0 expired
Where Azelex sits in the generic timeline
Imminent generic cliff: earliest active US patent for Azelex expires in 2027 (~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.
- Formulation — 2 patents
- Method of Use — 2 patents
FDA U-codes carved out by Azelex 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-1796 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Azelex drug page →
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This patent protects a formulation of an alcohol-free cosmetic or pharmaceutical foam composition that enhances skin penetration.USPTO title: Penetrating pharmaceutical foam
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This patent protects a foamable composition for a pharmaceutical or cosmetic product, specifically a vehicle combining a polar solvent and a hydrophobic carrier.USPTO title: Foamable composition combining a polar solvent and a hydrophobic carrier
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This patent protects a foamable pharmaceutical carrier for delivering a dicarboxylic acid or ester as a benefit agent.USPTO title: Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
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This patent protects a therapeutic kit that releases a foam containing an antibiotic agent, such as Foamix Pharmaceuticals' Azelex, for safe and effective use.USPTO title: Antibiotic kit and composition and uses thereof
Sources
- FDA Orange Book — patents listed against Azelex (NDA filed 1995)
- Azelex drug profile — full patent estate, indications, clinical trials, pricing
- Leo Pharma As patent portfolio
- Patent cliff 2027 — 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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