Acthar Gel generics — when can they launch?
Acthar Gel (CORTICOTROPIN) · Mallinckrodt Ireland · 9 active US patents · 0 expired
Where Acthar Gel sits in the generic timeline
Long-dated protection: earliest active US patent for Acthar Gel extends to 2041 (~15 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 — 8 patents
- Formulation — 1 patent
FDA U-codes carved out by Acthar Gel 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-3686 | (no description) |
U-3904 | (no description) |
U-3912 | (no description) |
U-3917 | (no description) |
U-3916 | (no description) |
U-3910 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Acthar Gel drug page →
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This patent protects methods of modulating pericytes in subjects who need it.USPTO title: Methods of modulating pericytes
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This patent protects methods of modulating pericytes in subjects who need it.USPTO title: Methods of modulating pericytes
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This patent protects methods of modulating pericytes in subjects who need it.USPTO title: Methods of modulating pericytes
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This patent protects a method for storing and warming a specific type of corticotropin composition, such as Acthar Gel, in a multiple-dose vial.USPTO title: Methods for storing and warming purified corticotropin compositions
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This patent protects a kit and method for preparing and delivering purified corticotropin extracted from a whole porcine pituitary gland.USPTO title: Kits for preparing and delivering purified corticotropin
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This patent protects a method of using a purified corticotropin composition, specifically Acthar Gel, by storing and warming it before injecting 80 USP units into a human subject.USPTO title: Methods for storing and warming purified corticotropin compositions
Sources
- FDA Orange Book — patents listed against Acthar Gel (NDA filed 1950)
- Acthar Gel drug profile — full patent estate, indications, clinical trials, pricing
- Mallinckrodt Ireland patent portfolio
- Patent cliff 2041 — 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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