Qutenza generics — when can they launch?
Qutenza (CAPSAICIN) · Averitas · 2 active US patents · 0 expired
Where Qutenza sits in the generic timeline
Imminent generic cliff: earliest active US patent for Qutenza expires in 2028 (~3 years 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
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Qutenza drug page →
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This patent protects a method for siliconizing the backing layer of a transdermal therapeutic system, specifically one used in a product like Qutenza.USPTO title: Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer or the system and use of said back layer
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This patent protects a therapeutic patch for transdermal delivery of capsaicin or a compound analogous to capsaicin.USPTO title: Therapeutic patch for transdermal delivery of capsaicin
Sources
- FDA Orange Book — patents listed against Qutenza (NDA filed 2009)
- Qutenza drug profile — full patent estate, indications, clinical trials, pricing
- Averitas patent portfolio
- Patent cliff 2028 — 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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