POSACONAZOLE generics — when can they launch?
POSACONAZOLE (POSACONAZOLE) · · 6 active US patents · 0 expired
Where POSACONAZOLE sits in the generic timeline
Imminent generic cliff: earliest active US patent for POSACONAZOLE 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.
- Formulation — 4 patents
- Method of Use — 2 patents
FDA U-codes carved out by POSACONAZOLE 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-3171 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the POSACONAZOLE drug page →
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them, particularly in relation to a drug-degrading agent.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them, particularly in relation to a drug-degrading agent.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects compositions of sulfoalkyl ether cyclodextrin and methods for making and using them, particularly in relation to a drug-degrading agent.USPTO title: Sulfoalkyl ether cyclodextrin compositions
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This patent protects stabilized aqueous solutions of posaconazole for intravenous administration that include a modified β-cyclodextrin and a chelating agent.USPTO title: Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
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This patent protects stabilized aqueous solutions of posaconazole for intravenous administration that include a modified β-cyclodextrin and a chelating agent.USPTO title: Posaconazole intravenous solution formulations stabilized by substituted β-cyclodextrin
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This patent protects low-chloride alkylated cyclodextrin compositions and processes for preparing and using them.USPTO title: Alkylated cyclodextrin compositions and processes for preparing and using the same
Sources
- FDA Orange Book — patents listed against POSACONAZOLE (NDA filed 2005)
- POSACONAZOLE drug profile — full patent estate, indications, clinical trials, pricing
- 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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