Sporanox generics — when can they launch?
Sporanox (itraconazole) · Sebela Ireland Ltd · 6 active US patents · 0 expired
Where Sporanox sits in the generic timeline
Imminent generic cliff: earliest active US patent for Sporanox expires in 2028 (~2 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 — 3 patents
- Formulation — 3 patents
FDA U-codes carved out by Sporanox 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-1054 | (no description) |
U-2453 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Sporanox drug page →
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This patent protects a solid dispersion product containing itraconazole and hydroxypropyl methylcellulose with improved bioavailability.USPTO title: Itraconazole compositions with improved bioavailability
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This patent protects pharmaceutical compositions, including solid oral dosage forms, containing itraconazole for treating fungal infections.USPTO title: Itraconazole compositions and dosage forms, and methods of using the same
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This patent protects pharmaceutical compositions, including solid oral dosage forms, containing itraconazole, such as Sporanox, and methods for making and using them.USPTO title: Itraconazole compositions and dosage forms, and methods of using the same
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This patent protects pharmaceutical compositions, including solid oral dosage forms, containing itraconazole, such as Sporanox, and methods for making and using them.USPTO title: Itraconazole compositions and dosage forms, and methods of using the same
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This patent protects pharmaceutical compositions containing itraconazole, including solid oral dosage forms, and methods of using them to treat fungal infections.USPTO title: Itraconazole compositions and dosage forms, and methods of using the same
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This patent protects pharmaceutical compositions, including solid oral dosage forms, containing itraconazole for treating fungal infections.USPTO title: Itraconazole compositions and dosage forms, and methods of using the same
Sources
- FDA Orange Book — patents listed against Sporanox (NDA filed 1992)
- Sporanox drug profile — full patent estate, indications, clinical trials, pricing
- Sebela Ireland Ltd patent portfolio
- Patent cliff 2028 — 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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