TRIFAROTENE generics — when can they launch?
TRIFAROTENE (TRIFAROTENE) · · 3 active US patents · 0 expired
Where TRIFAROTENE sits in the generic timeline
Mid-term cliff: earliest active US patent for TRIFAROTENE 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.
- Method of Use — 2 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by TRIFAROTENE 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-1033 | (no description) |
U-134 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the TRIFAROTENE drug page →
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This patent protects novel ligand compounds and pharmaceutical or cosmetic compositions containing them, useful in human and veterinary medicine or cosmetics.USPTO title: Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof
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This patent protects a method of using a specific gel composition containing a particular solubilized retinoid, such as trifarotene, for cosmetic and dermatological purposes.USPTO title: Topical compositions in the form of a gel containing a particular solubilized retinoid
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This patent protects a method of using a retinoid in a specific type of topical composition, such as in cosmetics or dermatology.USPTO title: Topical compositions containing a retinoid of the oil-in-water emulsion type
Sources
- FDA Orange Book — patents listed against TRIFAROTENE (NDA filed 2019)
- TRIFAROTENE 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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