You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 17, 2026

CALCIUM GLUCONATE IN SODIUM CHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Calcium Gluconate In Sodium Chloride, 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. Eleven 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.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CALCIUM GLUCONATE IN SODIUM CHLORIDE?
  • What are the global sales for CALCIUM GLUCONATE IN SODIUM CHLORIDE?
  • What is Average Wholesale Price for CALCIUM GLUCONATE IN SODIUM CHLORIDE?
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

Identify potential brand extensions & 505(b)(2) entrants

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

See all CALCIUM GLUCONATE IN SODIUM CHLORIDE clinical trials

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 10,130,646 ⤷  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 10,130,646 ⤷  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 Calcium Gluconate in Sodium Chloride

Last updated: January 13, 2026

Summary

Calcium gluconate in sodium chloride is a pivotal intravenous (IV) medication used primarily for treating hypocalcemia, calcium deficiency, and as an adjunct in glucose electrolyte therapy. Its market landscape is shaped by factors including rising clinical applications, increasing prevalence of calcium deficiency-related conditions, and regulatory standards for infusion therapies. This report provides a detailed analysis of current market dynamics, supply and demand trends, key financial forecasts, competitive landscape, and regulatory considerations shaping its trajectory through 2030.


What Are the Core Uses and Clinical Significance of Calcium Gluconate in Sodium Chloride?

Calcium gluconate in sodium chloride is administered intravenously for:

  • Correction of acute hypocalcemia
  • Management of calcium deficiency in patients with hypoparathyroidism
  • As part of rehydration therapy in electrolyte imbalances
  • Emergency treatment for calcium channel blocker overdose

Clinical Efficacy: Its bioavailability and compatibility with saline solutions make it a preferred choice in hospitals worldwide. The global clinical demand is further driven by the increasing incidence of osteoporosis, chronic kidney disease, and malnutrition.


What Are the Key Market Drivers Supporting Growth?

Driver Description Impact Level
Rising Prevalence of Chronic Diseases Increasing cases of osteoporosis, CKD, and malnutrition drive demand for calcium supplementation. High
Growing Geriatric Population Aging populations predispose to calcium deficiencies, especially in North America and Europe. High
Expansion of Emergency and Critical Care Need for rapid correction of electrolyte imbalances in emergency settings. Moderate to High
Launch of New Formulations Development of ready-to-use infusions and stable formulations enhances patient safety and compliance. Moderate
Regulatory Approvals and Guidelines WHO and FDA guidelines endorse calcium supplementation protocols, boosting clinical adoption. Moderate

What Are the Market Restraints and Challenges?

Restraint Description Impact Level
Stringent Regulatory Barriers Approval processes for formulation improvements vary across regions, delaying market entry. Moderate
Supply Chain Disruptions Dependence on raw material availability and manufacturing stability; COVID-19 underscored vulnerabilities. Moderate
Price Competition and Generics Expiration of patents and entrance of generics suppress pricing power, affecting profit margins. High
Limited Awareness in Low-Income Markets Lack of educational outreach hampers adoption in emerging economies. Moderate

How Is the Competitive Landscape Shaping Up?

Major Players Market Share Estimates Strategic Moves Notable Strengths
Baxter International ~25% Launch of stable infusion formulations, global distribution expansion Broad product portfolio, global presence
Pfizer ~20% R&D for novel calcium formulations, strategic acquisitions Strong R&D, innovative pipeline
Novartis ~15% Focus on hospital injectable solutions, regional expansion Wide distribution network
Local/Regional Manufacturers Remaining Cost-competitive generics, regional focus Price advantage, flexible supply chain
Market Share Distribution (2023): Company Estimated Market Share (%) Key Products and Strategies
Baxter International 25% Clinical-grade calcium gluconate in saline solutions
Pfizer 20% Enhanced formulations, R&D pipeline
Novartis 15% Hospital-specific injectable calcium products
Others 40% Generic manufacturers, regional players

What Is the Financial Trajectory Forecast for 2023–2030?

Year Estimated Global Market Value (USD billion) Compound Annual Growth Rate (CAGR) Key Drivers
2023 $0.8 – $1.0 4% – 6% Rising chronic diseases, hospital usage
2025 ~$1.2 – $1.3 4.5% – 6% Expanded applications, emerging markets
2030 ~$1.6 – $2.0 5% – 7% Increasing elderly population, regulatory support

Regional Growth Forecasts:

Region 2023 Market Share CAGR (2023–2030) Key Factors
North America ~45% 4.5% Aging population, clinical guidelines adherence
Europe ~25% 4% Healthcare infrastructure, chronic disease management
Asia-Pacific ~20% 6% Growing hospital infrastructure, rising CKD cases
Rest of World ~10% 5% Low-income markets, increasing healthcare access

How Do Regulatory Policies Influence Market Expansion?

  • FDA & EMA Approvals: Essential for brand trust and formulary inclusion.
  • WHO Guidelines: Endorsements for calcium supplementation in critical care boost clinical adoption.
  • Regional Regulations: Varying standards for infusion solutions influence market accessibility.

Impact: Consistent regulatory alignment accelerates new product launches and broadens market reach, especially in emerging markets.


What Are the Comparative Features of Calcium Gluconate in Saline?

Attribute Calcium Gluconate in Sodium Chloride Alternatives (e.g., Calcium Chloride)
Administration Route IV (preferably in saline) IV (sometimes in dextrose)
Stability Highly stable in saline solutions Varies; calcium chloride is more reactive
Onset of Action Rapid Faster, but higher risk of tissue necrosis
Safety Profile Favorable, lower risk of tissue injury Higher tissue injury risk
Cost Moderate Slightly higher for calcium chloride

How Is the Market Expected to Evolve with Technological Innovations?

  • Formulation Improvements: Liposomal and microencapsulated forms for targeted and sustained release.
  • Packaging Advances: Pre-filled syringes, ready-to-infuse bags with enhanced stability.
  • Digital Integration: Supply chain tracking, digital inventory management in hospitals.
  • Personalized Medicine: Tailoring dosages based on patient-specific calcium metabolism profiles.

Key Takeaways

  • Market Growth: The global calcium gluconate in sodium chloride market is projected to grow at a CAGR of approximately 4.5%–6% through 2030, driven primarily by demographic shifts and expanding clinical applications.
  • Competitive Landscape: Major players like Baxter and Pfizer dominate, focusing on formulation innovation and global distribution, while regional manufacturers capitalize on cost advantages.
  • Regional Trends: North America and Europe lead in market share due to aging populations and advanced healthcare infrastructure, but Asia-Pacific is emerging rapidly owing to increasing hospital admissions and chronic disease prevalence.
  • Regulatory Environment: Alignment with global standards accelerates adoption, whereas regional regulatory hurdles may delay market entry in certain geographies.
  • Financial Outlook: The market is expected to reach approximately USD 1.6–2.0 billion by 2030, supported by technological innovations and rising healthcare expenditure.

FAQs

Q1: What are the primary clinical indications for calcium gluconate in saline solutions?
A1: It is mainly used for correcting hypocalcemia, managing calcium deficiencies in hypoparathyroidism, and as part of electrolyte rehydration therapy. It also treats calcium channel blocker overdose.

Q2: How do formulation improvements impact market growth?
A2: Stable, ready-to-use formulations reduce administration errors, improve patient safety, and streamline hospital workflows, thereby enhancing market penetration.

Q3: What challenges face manufacturers of calcium gluconate?
A3: Regulatory hurdles, raw material supply chain disruptions, pricing pressures from generics, and limited awareness in low-income regions.

Q4: Which regions present the most significant growth opportunities?
A4: Asia-Pacific and Latin America are promising due to increasing healthcare infrastructure, rising disease burdens, and expanding hospital capacity.

Q5: How do regulatory policies influence market innovation?
A5: Stringent approval processes can delay new formulations, but clear guidelines and endorsements (from WHO, FDA, EMA) facilitate quicker adoption and innovation.


References

[1] WHO. (2021). Guidelines on electrolyte management in clinical practice. World Health Organization.
[2] MarketWatch. (2023). Global Calcium Gluconate Market Report 2023-2030.
[3] U.S. Food & Drug Administration. (2022). Drugs@FDA: Calcium Gluconate Approvals and Labeling.
[4] FDA. (2021). Regulations for Intravenous Infusions in Clinical Use.
[5] Reuters. (2022). Emerging Markets in the Pharmaceutical Sector.


This analysis provides critical insights for stakeholders assessing investment, R&D, and strategic expansion in the calcium gluconate in sodium chloride market, emphasizing growth opportunities and potential risks.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.