Ferriprox generics — when can they launch?
Ferriprox (DEFERIPRONE) · Chiesi · 8 active US patents · 0 expired
Where Ferriprox sits in the generic timeline
Imminent generic cliff: earliest active US patent for Ferriprox expires in 2029 (~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.
- Method of Use — 6 patents
- Formulation — 2 patents
FDA U-codes carved out by Ferriprox 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-3083 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Ferriprox drug page →
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This patent protects a liquid formulation of the drug deferiprone that has a palatable taste due to a taste masking composition.USPTO title: Liquid formulation for deferiprone with palatable taste
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This patent protects a liquid formulation of the drug deferiprone that has a palatable taste due to a taste masking composition.USPTO title: Liquid formulation for deferiprone with palatable taste
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This patent protects delayed release tablets containing deferiprone, also known as Ferriprox, for oral administration.USPTO title: Delayed release deferiprone tablets and methods of using the same
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This patent protects delayed release tablets containing deferiprone for oral administration, specifically for twice daily use.USPTO title: Delayed release deferiprone tablets and methods of using the same
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This patent protects delayed release tablets containing deferiprone, also known as Ferriprox, for oral administration.USPTO title: Delayed release deferiprone tablets and methods of using the same
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This patent protects delayed release tablets containing deferiprone for oral administration, specifically for twice daily use.USPTO title: Delayed release deferiprone tablets and methods of using the same
Sources
- FDA Orange Book — patents listed against Ferriprox (NDA filed 2011)
- Ferriprox drug profile — full patent estate, indications, clinical trials, pricing
- Chiesi patent portfolio
- Patent cliff 2029 — 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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