Artesunate generics — when can they launch?
Artesunate (ARTESUNATE) · Amivas · 2 active US patents · 0 expired
Where Artesunate sits in the generic timeline
Long-dated protection: earliest active US patent for Artesunate extends to 2044 (~18 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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Artesunate 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-4433 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Artesunate drug page →
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This patent protects methods of manufacturing powders containing artesunate, a process for producing these powders, and pharmaceutical compositions containing them.USPTO title: Artesunate powders, pharmaceutical compositions and methods of manufacture
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This patent protects methods for manufacturing and compositions of artesunate powders that can be easily sterilized and packaged.USPTO title: Artesunate powders, pharmaceutical compositions and methods of manufacture
Sources
- FDA Orange Book — patents listed against Artesunate (NDA filed 2020)
- Artesunate drug profile — full patent estate, indications, clinical trials, pricing
- Amivas patent portfolio
- Patent cliff 2044 — 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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