ECONAZOLE NITRATE generics — when can they launch?
ECONAZOLE NITRATE (ECONAZOLE NITRATE) · · 1 active US patent · 0 expired
Where ECONAZOLE NITRATE sits in the generic timeline
Mid-term cliff: earliest active US patent for ECONAZOLE NITRATE expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 1 patent
Sample patent estate
Showing 1 of 1 active US patents. View full estate on the ECONAZOLE NITRATE drug page →
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This patent protects a water-based composition for treating infections caused by dermatophyte fungus using econazole or a pharmaceutically acceptable salt thereof.USPTO title: Econazole composition and methods of treatment therewith
Sources
- FDA Orange Book — patents listed against ECONAZOLE NITRATE (NDA filed 1982)
- ECONAZOLE NITRATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2031 — 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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