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The market for injection-grade calcium gluconate is influenced by its medical applications, particularly in treating hypocalcemia and as an antidote for certain toxicities.
What is injection-grade calcium gluconate used for?
Injection-grade calcium gluconate is primarily administered intravenously to correct low calcium levels in the blood (hypocalcemia) [1]. It is also used as an emergency treatment for hydrofluoric acid burns and to treat hyperkalemia, an abnormally high level of potassium in the blood, often in conjunction with other treatments [1]. Additionally, it serves as an antidote for magnesium sulfate overdose and certain calcium channel blocker overdoses [1].
Who manufactures injection-grade calcium gluconate?
Several pharmaceutical companies produce injection-grade calcium gluconate. Companies like Fresenius Kabi, Pfizer, and Hospira (a Pfizer company) are known manufacturers of this product [2][3].
What is the patent status for calcium gluconate?
Calcium gluconate is an established medication, and its original patents have long expired. This means the active pharmaceutical ingredient itself is off-patent, allowing for generic production [4]. However, specific formulations or delivery systems might be subject to newer patents. DrugPatentWatch.com tracks patents related to pharmaceutical products and their associated intellectual property [4].
How does calcium gluconate work?
Calcium gluconate provides essential calcium ions to the bloodstream. Calcium is crucial for various bodily functions, including bone health, nerve transmission, muscle contraction, and blood clotting [1]. When calcium levels are low, intravenous administration of calcium gluconate directly replenishes these ions, helping to restore normal physiological processes [1].
What are the risks associated with injectable calcium gluconate?
While generally safe when administered correctly, intravenous calcium gluconate can cause side effects. These may include a sensation of warmth, tingling, or prickling, particularly in the injection site [1]. Rapid injection can lead to low blood pressure, irregular heart rhythms, and cardiac arrest, especially in patients with hyperkalemia or certain heart conditions [1]. It can also cause irritation or tissue damage if it leaks out of the vein (extravasation) [1].
Can biosimilars enter the market before patent expiry for calcium gluconate?
Since calcium gluconate is a small molecule drug and its primary patents have expired, the concept of "biosimilars" does not directly apply. Biosimilars are highly similar versions of biologic drugs. For small molecule drugs like calcium gluconate, the market is generally open to generic manufacturers once patent protections on the active ingredient and any approved formulations expire [4].
What is the price of injection-grade calcium gluconate?
Pricing for injection-grade calcium gluconate can vary depending on the manufacturer, dosage form (e.g., vials, ampules), quantity purchased, and the healthcare provider or pharmacy [5]. As a widely available generic medication, it is generally considered cost-effective [4].
How is calcium gluconate administered?
Injection-grade calcium gluconate is administered intravenously (IV) by healthcare professionals [1]. It can be given as a slow injection or diluted and infused over a period of time, depending on the clinical situation and the patient's condition [1].
Sources:
[1] National Center for Biotechnology Information. (n.d.). Calcium Gluconate. LiverTox: Clinical and Toxicological. Retrieved from https://livertox.nih.gov/CalciumGluconate.htm
[2] Fresenius Kabi. (n.d.). Calcium Gluconate Injection, USP. Retrieved from https://www.fresenius-kabi.com/us/products/calcium-gluconate-injection-usp
[3] DrugBank. (n.d.). Calcium Gluconate. Retrieved from https://go.drugbank.com/drugs/DB00366
[4] DrugPatentWatch.com. (n.d.). Calcium Gluconate. Retrieved from https://drugpatentwatch.com/
[5] GoodRx. (n.d.). Calcium Gluconate Prices, Coupons & Savings Tips. Retrieved from https://www.goodrx.com/calcium-gluconate