Triferic generics — when can they launch?
Triferic (FERRIC PYROPHOSPHATE CITRATE) · Rockwell Medical Inc · 4 active US patents · 0 expired
Where Triferic sits in the generic timeline
Imminent generic cliff: earliest active US patent for Triferic expires in 2027 (~1 year 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 — 4 patents
FDA U-codes carved out by Triferic 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-1656 | (no description) |
U-2801 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Triferic drug page →
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This patent protects a packaged bicarbonate solution for use in dialysis treatment that includes dissolved ferric pyrophosphate.USPTO title: Packaging of ferric pyrophosphate for dialysis
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This patent protects methods for preparing and using a highly water-soluble ferric pyrophosphate citrate chelate composition for treating iron deficiency.USPTO title: Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
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This patent protects methods for preparing and using a highly water-soluble ferric pyrophosphate citrate chelate composition for treating iron deficiency.USPTO title: Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
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This patent protects methods for preparing and using a highly water-soluble ferric pyrophosphate citrate chelate composition.USPTO title: Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
Sources
- FDA Orange Book — patents listed against Triferic (NDA filed 2015)
- Triferic drug profile — full patent estate, indications, clinical trials, pricing
- Rockwell Medical Inc patent portfolio
- Patent cliff 2027 — 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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