Elocon generics — when can they launch?
Elocon (MOMETASONE FUROATE) · Merck & Co. · 22 active US patents · 1 expired
Where Elocon sits in the generic timeline
Imminent generic cliff: earliest active US patent for Elocon 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 — 14 patents
- Formulation — 7 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Elocon 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-2272 | (no description) |
U-3297 | (no description) |
U-3296 | (no description) |
U-3295 | (no description) |
Sample patent estate
Showing 6 of 22 active US patents. View full estate on the Elocon drug page →
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This patent protects biodegradable implants for treating sinusitis that release a sustained therapeutic, such as an antibiotic or steroidal anti-inflammatory agent, over time.USPTO title: Sinus delivery of sustained release therapeutics
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USPTO title: Device and methods for treating paranasal sinus conditions
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USPTO title: Expandable devices and methods for treating a nasal or sinus condition
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This patent protects methods and devices for crimping self-expanding medical devices.USPTO title: Methods and devices for crimping self-expanding devices
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This patent protects systems, devices, and methods for delivering an implant to a bodily cavity, such as a sinus.USPTO title: Systems, devices, and method for treating a sinus condition
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This patent protects a stable fixed dose pharmaceutical composition for nasal administration that contains mometasone or its salt and olopatadine or its salt.USPTO title: Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
Sources
- FDA Orange Book — patents listed against Elocon (NDA filed 1987)
- Elocon drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. 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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