Accrufer generics — when can they launch?
Accrufer (FERRIC MALTOL) · Shield Tx · 3 active US patents · 0 expired
Where Accrufer sits in the generic timeline
Mid-term cliff: earliest active US patent for Accrufer 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 — 3 patents
FDA U-codes carved out by Accrufer 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-2603 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Accrufer drug page →
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This patent protects a composition or kit that combines an iron hydroxypyrone with a gastrointestinal inflammation inhibiting agent for treating or preventing anemia or H. pylori infections.USPTO title: Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
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This patent protects a dosage regimen of 30 mg of ferric trimaltol taken twice daily for treating iron deficiency with or without anaemia.USPTO title: Dosage regimen of ferric trimaltol
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USPTO title: Crystalline forms of ferric maltol
Sources
- FDA Orange Book — patents listed against Accrufer (NDA filed 2019)
- Accrufer drug profile — full patent estate, indications, clinical trials, pricing
- Shield Tx patent portfolio
- 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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