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Last Updated: December 12, 2025

CALCIUM CHLORIDE 10% Drug Patent Profile


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Which patents cover Calcium Chloride 10%, and what generic alternatives are available?

Calcium Chloride 10% is a drug marketed by Am Regent, Amneal, Extrovis, Intl Medication Sys, Medefil Inc, Somerset, Square Pharms Plc, and Hospira. and is included in eight NDAs.

The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.

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Summary for CALCIUM CHLORIDE 10%
US Patents:0
Applicants:8
NDAs:8
Finished Product Suppliers / Packagers: 13
DailyMed Link:CALCIUM CHLORIDE 10% at DailyMed
Drug patent expirations by year for CALCIUM CHLORIDE 10%
Pharmacology for CALCIUM CHLORIDE 10%

US Patents and Regulatory Information for CALCIUM CHLORIDE 10%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 209088-001 Jul 27, 2017 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Square Pharms Plc CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 217463-001 Sep 29, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Intl Medication Sys CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 203477-001 May 9, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  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 Calcium Chloride 10%

Last updated: July 30, 2025


Introduction

Calcium chloride 10% solution is a widely utilized pharmaceutical product with extensive applications in medical, industrial, and food sectors. Its versatility as an electrolyte replenisher, a de-icing agent, and a food additive renders it a strategic commodity with significant market relevance. This analysis delineates the current market dynamics and forecasts the financial trajectory for calcium chloride 10%, emphasizing demand drivers, competitive landscape, regulatory influences, and growth opportunities.


Market Overview

The global calcium chloride market was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 1.8 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of around 5.2% (1). The pharmaceutical segment occupies a notable portion of this market, driven by increasing healthcare needs, particularly in electrolyte management and emergency medicine. The 10% concentration solution is predominantly employed for intravenous (IV) administration, demanding strict compliance with pharmaceutical-grade standards.


Demand Drivers

Healthcare Sector Expansion

Rising incidences of electrolyte imbalances, especially hypocalcemia, augment demand for calcium chloride solutions. Hospitals and clinics increasingly rely on calcium chloride 10% for rapid correction of calcium deficiencies, especially during critical care and cardiac emergencies. The aging population further propels this demand, as age-related nutritional deficits and chronic conditions heighten electrolyte therapy needs.

Growth in Emergency Medical Services and ICU Use

Emergency departments and intensive care units (ICUs) are primary consumers of calcium chloride 10% solutions. The convenience of IV administration and immediate physiological effects make it indispensable. The global expansion of healthcare infrastructure, especially in emerging economies, amplifies demand in these segments.

Industrial and Food Applications

Though primarily pharmaceutical, calcium chloride 10% solutions are also used in food preservation, as a firming agent, and in industrial de-icing and dust control. These ancillary markets provide complementary demand streams, albeit with lower growth rates compared to healthcare.


Market Dynamics

Regulatory Landscape

Pharmaceutical-grade calcium chloride requires adherence to stringent regulations, including Good Manufacturing Practices (GMP) and approval from authorities like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Regulatory compliance influences market entry barriers and product pricing.

The evolving regulatory environment, with tighter quality controls and standards, benefits established manufacturers with robust compliance frameworks but challenges new entrants due to high standards and certification costs.

Competitive Landscape

The presence of multiple globally recognized manufacturers, such as Sigma-Aldrich (part of Merck), Brenntag, and local pharma companies, perpetuates a competitive environment. Key differentiation factors include purity, sterility, production capacity, and supply chain robustness.

In addition, generic manufacturers look to capitalize on the demand after patent expirations, increasing price competition and market saturation possibilities.

Supply Chain and Raw Material Availability

Calcium chloride is primarily produced via mining of limestone and subsequently through chemical synthesis. Fluctuations in raw material prices, geopolitical factors, and environmental regulations concerning mining and manufacturing operations influence costs and product availability.

Supply chain disruptions, notably COVID-19 pandemic-related logistics issues, temporarily impacted supply but have generally normalized, stabilizing the market.

Technological Innovation

Advancements in manufacturing processes, such as improved purification and sterilization techniques, enhance product quality and safety. The development of ready-to-use, pre-filled IV bags containing calcium chloride 10% solution increases convenience and safety, meeting evolving clinical needs.


Financial Trajectory and Market Forecast

Revenue Growth

Forecasting indicates a steady CAGR of approximately 5.2% for calcium chloride 10% solutions over the next eight years, driven by increasing healthcare expenditure, rising prevalence of calcium deficiencies, and expanding emergency medical services globally.

The pharmaceutical segment is expected to dominate revenue share, with emerging markets in Asia-Pacific and Latin America exhibiting the highest growth rates due to expanding healthcare infrastructure and increasing awareness.

Pricing Trends

Pricing remains relatively stable but is subject to fluctuation based on raw material costs and regulatory compliance expenses. Premium formulations with enhanced sterility and stability may command higher prices, influencing revenue streams.

Market Penetration and Expansion Opportunities

Emerging markets present significant growth potential, especially where infrastructural investments in healthcare are ongoing. Additionally, expanding use in non-medical applications (food processing, de-icing) offers supplementary revenue avenues.


Challenges and Risks

  • Regulatory Hurdles: Delays in approvals or stringent regulations can hamper market entry and expansion.
  • Raw Material Price Volatility: Fluctuations in cost impact profit margins.
  • Competition from Generics: Price erosion from commodity-like generic products affects overall profitability.
  • Environmental Regulations: Stricter controls on mining and manufacturing practices may increase operational costs.
  • Supply Chain Disruptions: Future geopolitical or pandemic-related disruptions could impact availability and pricing.

Strategic Recommendations for Market Stakeholders

  • Quality Assurance: Focus on achieving and maintaining high standards to meet stringent regulatory and clinical requirements.
  • Innovation: Invest in product development, such as pre-filled sterile solutions and stable formulations, to differentiate offerings.
  • Geographical Expansion: Penetrate high-growth regions like Asia-Pacific, Latin America, and Africa with tailored marketing and distribution strategies.
  • Supply Chain Optimization: Strengthen procurement channels and logistics infrastructure to mitigate disruptions.
  • Regulatory Engagement: Proactively engage with regulatory authorities to streamline approvals and ensure compliance.

Key Takeaways

  • The calcium chloride 10% market is poised for sustainable growth, driven by increased healthcare needs, particularly in emergency care and electrolyte management.
  • Demand in emerging markets will accelerate growth, offering significant expansion opportunities.
  • Regulatory and raw material costs are critical factors influencing product pricing and profitability.
  • Competitive differentiation hinges on product quality, safety, and supply chain reliability.
  • Innovations in formulation and packaging can enhance market share and meet evolving clinical and industrial needs.

FAQs

  1. What are the primary applications of calcium chloride 10% in healthcare?
    It is mainly used for treating hypocalcemia, as an electrolyte replenisher, during cardiac resuscitation, and in emergency medicine for rapid calcium correction.

  2. How does regulatory compliance impact the market for calcium chloride 10% solutions?
    Strict adherence to GMP, sterility, and safety standards influences manufacturing costs and market entry, with compliance serving as a competitive advantage.

  3. What are the key growth markets for calcium chloride 10% solutions?
    Asia-Pacific, Latin America, and the Middle East exhibit robust growth prospects due to expanding healthcare infrastructure and demand for emergency medical treatments.

  4. How might raw material fluctuations affect the market?
    Variations in the costs of mining and chemical synthesis raw materials can impact overall production costs, influencing pricing and supply stability.

  5. What innovations could shape the future of calcium chloride 10% products?
    Developments in sterile packaging, ready-to-use formulations, and stability enhancements will support clinical adoption and market growth.


References

  1. Transparency Market Research. (2022). Calcium Chloride Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2022-2030.

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