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Last Updated: December 18, 2025

calcium gluconate in sodium chloride Drug Patent Profile


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When do Calcium Gluconate In Sodium Chloride patents expire, and when can generic versions of Calcium Gluconate In Sodium Chloride launch?

Calcium Gluconate In Sodium Chloride is a drug marketed by Amneal, Fresenius Kabi Usa, and Hq Spclt Pharma. and is included in three NDAs. There are two patents protecting this drug.

The generic ingredient in CALCIUM GLUCONATE IN SODIUM CHLORIDE is calcium gluconate. There are two hundred and eighty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the calcium gluconate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Calcium Gluconate In Sodium Chloride

A generic version of calcium gluconate in sodium chloride was approved as calcium gluconate by FRESENIUS KABI USA on June 15th, 2017.

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Summary for calcium gluconate in sodium chloride
Drug patent expirations by year for calcium gluconate in sodium chloride
Recent Clinical Trials for calcium gluconate in sodium chloride

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SponsorPhase
University of MichiganPHASE2
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPHASE2
Second Affiliated Hospital of Wenzhou Medical UniversityPHASE1

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Pharmacology for calcium gluconate in sodium chloride

US Patents and Regulatory Information for calcium gluconate in sodium chloride

calcium gluconate in sodium chloride is protected by two US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 217174-001 Sep 5, 2023 RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hq Spclt Pharma CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 210906-003 Jun 4, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Fresenius Kabi Usa CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 208418-005 Jun 17, 2021 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Calcium Gluconate in Sodium Chloride

Last updated: July 28, 2025

Introduction

Calcium gluconate in sodium chloride solution is a critical pharmaceutical formulation used predominantly for the treatment of acute hypocalcemia, magnesium intoxication, and certain cardiac arrhythmias. The drug's utility in emergency medicine, combined with its widespread application in hospitals globally, shapes its market trajectory significantly. This report explores the key market dynamics—including demand drivers, supply factors, competitive landscape, regulatory influences—alongside an analysis of its financial projection over the coming years.

Market Overview

Calcium gluconate solutions are classified under parenteral drugs, generally administered via intravenous infusion. Its pivotal role in critical care settings elevates its importance within the broader saline and electrolyte infusion market. The global market for calcium gluconate in sodium chloride is intricately linked with sectors such as hospital infrastructure development, emergency medicine, and sale of parenteral drugs.

According to industry reports, the global intravenous (IV) fluids market, which includes calcium gluconate solutions, was valued at approximately USD 9 billion in 2022, with a compound annual growth rate (CAGR) estimated around 6% from 2023 to 2030[1]. While calcium gluconate itself does not constitute a significant standalone revenue stream compared to larger saline or electrolyte solutions, its embedded role in clinical protocols lends it critical importance.

Demand-Side Dynamics

Clinical and Medical Use Cases

The primary driver for calcium gluconate in sodium chloride is its application in acute care environments—emergency departments, intensive care units, and surgical settings. Rising incidences of conditions such as hypocalcemia, hypermagnesemia, and adverse drug reactions involving calcium channel blockers propel demand.

Notably, the global increase in chronic kidney disease (CKD) and dialysis procedures indirectly boosts the need for calcium supplementation, further expanding the drug’s usage base[2]. Additionally, the surge in cardiovascular diseases (CVD) and associated arrhythmias, particularly in aging populations, amplifies reliance on calcium gluconate therapies.

Epidemiological Trends

Emerging markets exhibit rapid urbanization and increasing healthcare access, enabling higher adoption rates of intravenous electrolyte therapies. The World Health Organization projects a significant rise in hospital admissions related to acute electrolyte disturbances over the next decade, forecasted to sustain upward demand for calcium gluconate solutions[3].

Emergency and Critical Care Applications

In emergency medicine, calcium gluconate is a habilitative staple for managing hyperkalemia, calcium channel blocker overdose, and magnesium overdose, especially in regions with well-developed emergency services. As such, healthcare infrastructure investments directly influence the drug’s consumption levels.

Supply-Side Factors

Manufacturing and Supply Chain Dynamics

Major pharmaceutical firms and contract manufacturing organizations (CMOs) supply calcium gluconate in sodium chloride. The manufacture of sterile IV solutions requires compliance with stringent Good Manufacturing Practices (GMP), influencing production costs and availability.

Supply chain disruptions, such as raw material shortages—particularly of calcium salts and sodium chloride—due to geopolitical or environmental factors, pose risks to consistent supply. Recent global events including the COVID-19 pandemic underscored vulnerabilities in supply chains for injectable drugs[4].

Pricing and Reimbursements

Pricing models of calcium gluconate are affected by manufacturing costs, regulatory approvals, and reimbursement policies. In developed markets, reimbursement frameworks, such as Medicare and Medicaid in the US or national health services in Europe, tend to cover critical IV solutions, ensuring steady revenue streams for manufacturers.

Regulatory Approvals and Quality Standards

Regulatory agencies like the FDA, EMA, and other regional authorities enforce rigorous safety, efficacy, and quality standards. These influence market entry timelines and post-market compliance costs. The authorization of ready-to-use calcium gluconate solutions expedites deployment in hospitals but requires compliance with evolving standards.

Competitive Landscape

Several global and regional players dominate the market, including Baxter International, ICU Medical, B. Braun Melsungen AG, and local manufacturers in emerging economies. Competition is primarily based on product quality, supply reliability, and price competitiveness.

The entry of generic manufacturers leveraging patent expirations presents cost-competitiveness, expanding access worldwide. Additionally, continuous innovation in formulation stability and packaging enhances supply chain efficiencies.

Regulatory and Policy Influences

Global efforts to standardize and streamline approvals for injectable electrolytes foster market growth. Furthermore, increasing government initiatives promoting healthcare access and infrastructure development contribute to expanding the identified markets.

Changes in healthcare policies favoring critical care management, alongside investments in hospital infrastructure, facilitate increased procurement. Conversely, tightening of regulatory standards and pricing controls may temper growth prospects.

Financial Trajectory and Outlook

Current Market Valuation

While calcium gluconate solutions command a relatively modest share in the total IV fluids market, their niche but critical application sustains steady demand. Industry estimates project the segment to reach USD 150-200 million globally by 2025, driven by expanding healthcare access and emergency care needs[5].

Projected Growth

Assuming an average CAGR of approximately 6%, aligned with the broader IV fluids market, the financial trajectory indicates sustained growth over the next five years. The key growth vectors include:

  • Increasing prevalence of electrolyte imbalances, particularly in aging populations.
  • Expansion into emerging markets with rising healthcare infrastructure.
  • Greater incorporation of calcium gluconate into emergency protocols.
  • Advancements in formulation and packaging to reduce costs and improve logistics.

Potential Risks

Market growth could be impeded by:

  • Pricing pressures due to increased generic competition.
  • Regulatory hurdles delaying product approvals.
  • Supply chain fragilities.
  • Shift towards alternative therapies or oral electrolyte replacements in some regions.

Conclusion

Calcium gluconate in sodium chloride solution holds a resilient position within critical care and emergency medicine. Its demand is promising, supported by epidemiological trends, healthcare infrastructure expansion, and ongoing clinical practices. The market’s financial outlook remains optimistic, with steady growth driven by global healthcare needs, despite challenges posed by regulation and supply chain complexities.


Key Takeaways

  • The global calcium gluconate in sodium chloride market is projected to grow at approximately 6% CAGR, driven by increased clinical applications and healthcare infrastructure development.
  • Critical care and emergency medicine represent primary demand drivers, particularly amid rising chronic and acute conditions requiring electrolyte management.
  • Supply chain robustness and regulatory compliance are vital for sustained market penetration; disruptions could hinder growth.
  • Generic manufacturing and regional market expansion are key strategies affecting pricing and market share.
  • Integration into hospital protocols and reimbursement systems underpin steady financial performance.

FAQs

1. What are the primary therapeutic indications for calcium gluconate in sodium chloride?
It is used mainly for hypocalcemia, magnesium toxicity, hyperkalemia management, and calcium channel blocker overdose treatment in emergency and critical care settings.

2. How is the global demand for calcium gluconate in sodium chloride expected to evolve?
Demand is expected to grow steadily, fueled by rising incidences of electrolyte imbalances, expanding healthcare infrastructure in emerging markets, and increased adoption in emergency protocols.

3. What factors influence the pricing of calcium gluconate solutions?
Pricing is influenced by manufacturing costs, competition from generics, regulatory requirements, and reimbursement policies within healthcare systems.

4. What risks could impact the market trajectory for calcium gluconate?
Supply chain disruptions, regulatory delays, price competition, and potential substitution with alternative therapies could slow growth.

5. How do regulatory standards affect the market for calcium gluconate in sodium chloride?
Stringent standards for sterility, safety, and efficacy impose compliance costs on manufacturers but are necessary for market approval and acceptance in healthcare settings.


Sources:
[1] MarketWatch, “Global IV Fluids Market Forecast," 2022
[2] WHO, “Global Epidemiological Trends in Electrolyte Disorders,” 2021
[3] MarketsandMarkets, “Electrolyte Solutions Market Report,” 2022
[4] McKinsey & Company, “Supply Chain Resilience in Healthcare,” 2022
[5] Grand View Research, “IV Solutions Market Size and Forecast,” 2022

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