Kygevvi generics — when can they launch?
Kygevvi (DOXECITINE) · Ucb Inc · 2 active US patents · 0 expired
Where Kygevvi sits in the generic timeline
Long-dated protection: earliest active US patent for Kygevvi extends to 2036 (~10 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 — 2 patents
FDA U-codes carved out by Kygevvi 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-4358 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Kygevvi drug page →
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This patent protects a pharmacological therapy involving the administration of deoxynucleosides for treating diseases caused by unbalanced nucleotide pools, including mitochondrial DNA depletion syndromes.USPTO title: Deoxynucleoside therapy for diseases caused by unbalanced nucleotide pools including mitochondrial DNA depletion syndromes
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This patent protects polymorphic forms of deoxycytidine and methods for using compositions comprising these forms to treat mitochondrial diseases.USPTO title: Polymorphic forms of deoxycytidine, compositions comprising the same and uses
Sources
- FDA Orange Book — patents listed against Kygevvi (NDA filed 2025)
- Kygevvi drug profile — full patent estate, indications, clinical trials, pricing
- Ucb Inc patent portfolio
- Patent cliff 2036 — 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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