Injectafer generics — when can they launch?
Injectafer (FERRIC CARBOXYMALTOSE) · Am Regent · 24 active US patents · 0 expired
Where Injectafer sits in the generic timeline
Imminent generic cliff: earliest active US patent for Injectafer 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 — 20 patents
- Composition of Matter — 4 patents
FDA U-codes carved out by Injectafer 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-1620 | (no description) |
U-3472 | (no description) |
U-3637 | (no description) |
U-3051 | (no description) |
U-3435 | (no description) |
U-3115 | (no description) |
U-3635 | (no description) |
U-1432 | (no description) |
U-2556 | (no description) |
U-2555 | (no description) |
U-3636 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the Injectafer drug page →
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
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This patent protects a method of treating iron-related conditions using a single unit dosage of at least 0.6 grams of elemental iron via an iron carbohydrate complex.USPTO title: Methods and compositions for administration of iron
Sources
- FDA Orange Book — patents listed against Injectafer (NDA filed 2013)
- Injectafer drug profile — full patent estate, indications, clinical trials, pricing
- Am Regent 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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