CUPRIC SULFATE generics — when can they launch?
CUPRIC SULFATE (CUPRIC SULFATE) · · 15 active US patents · 0 expired
Where CUPRIC SULFATE sits in the generic timeline
Long-dated protection: earliest active US patent for CUPRIC SULFATE 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 — 9 patents
- Formulation — 6 patents
FDA U-codes carved out by CUPRIC SULFATE 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-3899 | (no description) |
U-3900 | (no description) |
Sample patent estate
Showing 6 of 15 active US patents. View full estate on the CUPRIC SULFATE drug page →
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This patent protects a stable injectable composition for parenteral nutrition that includes water and specific amounts of zinc, copper, selenium, or manganese per milliliter.USPTO title: Trace element compositions, methods of making and use
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This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.USPTO title: Trace element compositions, methods of making and use
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This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.USPTO title: Trace element compositions, methods of making and use
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This patent protects a stable injectable composition for parenteral nutrition that includes water and specific amounts of zinc, copper, selenium, or manganese per milliliter.USPTO title: Trace element compositions, methods of making and use
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This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.USPTO title: Trace element compositions, methods of making and use
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This patent protects a stable injectable composition for parenteral nutrition that includes zinc, copper, selenium, or manganese.USPTO title: Trace element compositions, methods of making and use
Sources
- FDA Orange Book — patents listed against CUPRIC SULFATE (NDA filed 1987)
- CUPRIC SULFATE drug profile — full patent estate, indications, clinical trials, pricing
- 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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