Derma-Smoothe/Fs generics — when can they launch?
Derma-Smoothe/Fs (FLUOCINOLONE ACETONIDE) · Eurofarma · 4 active US patents · 0 expired
Where Derma-Smoothe/Fs sits in the generic timeline
Imminent generic cliff: earliest active US patent for Derma-Smoothe/Fs 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 Derma-Smoothe/Fs 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-3410 | (no description) |
U-708 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Derma-Smoothe/Fs drug page →
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USPTO title: Injectable sustained release delivery devices
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USPTO title: Injectable sustained release delivery devices
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USPTO title: Injector apparatus and method of use
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This patent protects an ocular implantation device with a housing, needle, plunger, and rod that work together to move an implant through the needle.USPTO title: Ocular implantation device
Sources
- FDA Orange Book — patents listed against Derma-Smoothe/Fs (NDA filed 1963)
- Derma-Smoothe/Fs drug profile — full patent estate, indications, clinical trials, pricing
- Eurofarma 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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