Sotyktu generics — when can they launch?
Sotyktu (DEUCRAVACITINIB) · Bristol-Myers Squibb · 4 active US patents · 0 expired
Where Sotyktu sits in the generic timeline
Long-dated protection: earliest active US patent for Sotyktu extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 3 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Sotyktu 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-4452 | (no description) |
U-3434 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Sotyktu drug page →
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This patent protects a method of using Sotyktu.
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This patent protects a class of amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23, and/or IFN alpha responses.USPTO title: Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses
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This patent protects compounds useful in modulating IL-12, IL-23, and/or IFN alpha responses by acting on Tyk-2 to cause signal transduction inhibition.USPTO title: Amide-substituted heterocyclic compounds useful as modulators of IL-12, IL-23 and/or IFN alpha responses
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This patent protects stable and bioavailable formulations of the Tyk2 inhibitor BMS-986165 for treating autoimmune and auto-inflammatory diseases.USPTO title: Dosage forms for Tyk2 inhibitors
Sources
- FDA Orange Book — patents listed against Sotyktu (NDA filed 2022)
- Sotyktu drug profile — full patent estate, indications, clinical trials, pricing
- Bristol-Myers Squibb patent portfolio
- Patent cliff 2033 — 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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