Calcium Gluconate generics — when can they launch?
Calcium Gluconate (CALCIUM GLUCONATE) · · 8 active US patents · 0 expired
Where Calcium Gluconate sits in the generic timeline
Long-dated protection: earliest active US patent for Calcium Gluconate extends to 2037 (~11 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.
- Formulation — 8 patents
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Calcium Gluconate drug page →
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific weight percentages of calcium gluconate and calcium saccharate.USPTO title: Calcium gluconate solutions in flexible containers
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific weight percentages of calcium gluconate and calcium saccharate.USPTO title: Calcium gluconate solutions in flexible containers
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific weight percentages of calcium gluconate and calcium saccharate.USPTO title: Calcium gluconate solutions in flexible containers
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific weight percentages of calcium gluconate and calcium saccharate.USPTO title: Calcium gluconate solutions in flexible containers
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific weight percentages of calcium gluconate and calcium saccharate.USPTO title: Calcium gluconate solutions in flexible containers
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This patent protects a terminally sterilized aqueous calcium gluconate solution packaged in a flexible plastic container with specific concentration ranges.USPTO title: Calcium gluconate solutions in flexible containers
Sources
- FDA Orange Book — patents listed against Calcium Gluconate (NDA filed 2017)
- Calcium Gluconate drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2037 — 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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