Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container generics — when can they launch?
Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container (POTASSIUM PHOSPHATE, DIBASIC) · Pfizer · 5 active US patents · 0 expired
Where Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container sits in the generic timeline
Long-dated protection: earliest active US patent for Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container extends to 2039 (~13 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 — 5 patents
FDA U-codes carved out by Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container 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-2789 | (no description) |
U-4185 | (no description) |
Sample patent estate
Showing 5 of 5 active US patents. View full estate on the Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container drug page →
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This patent protects a sterile composition for injection comprised of potassium phosphates with no visible particulate and a manufacturing process for it.USPTO title: Potassium phosphates composition for injection
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This patent protects a ready-to-use potassium phosphate solution for phosphorus replacement therapy with specific concentration ranges.USPTO title: Ready-to-use potassium phosphates in sodium chloride solutions
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This patent protects a ready-to-use potassium phosphates solution in sodium chloride for phosphorus replacement therapy with specific phosphorus and potassium concentrations.USPTO title: Ready-to-use potassium phosphates in sodium chloride solutions
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This patent protects a ready-to-use potassium phosphate solution for phosphorus replacement therapy with specific concentration ranges.USPTO title: Ready-to-use potassium phosphates in sodium chloride solutions
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This patent protects a ready-to-use potassium phosphates solution in sodium chloride for phosphorus replacement therapy with specific phosphorus and potassium concentrations.USPTO title: Ready-to-use potassium phosphates in sodium chloride solutions
Sources
- FDA Orange Book — patents listed against Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container (NDA filed 1975)
- Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2039 — 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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