Calcium gluconate - Generic Drug Details

What are the generic drug sources for calcium gluconate and what is the scope of freedom to operate?

Calcium gluconate is the generic ingredient in two branded drugs marketed by Amneal, B Braun Medical, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, and Hq Spclt Pharma, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for calcium gluconate. Twelve suppliers are listed for this compound.

Summary for calcium gluconate

US Patents:	2
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	40
Patent Applications:	7,055
Drug Prices:	Drug price trends for calcium gluconate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for calcium gluconate
What excipients (inactive ingredients) are in calcium gluconate?	calcium gluconate excipients list
DailyMed Link:	calcium gluconate at DailyMed

See drug prices for calcium gluconate

Recent Clinical Trials for calcium gluconate

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

Sponsor	Phase
University of Michigan	PHASE2
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	PHASE2
Second Affiliated Hospital of Wenzhou Medical University	PHASE1

See all calcium gluconate clinical trials

Pharmacology for calcium gluconate

Drug Class	Blood Coagulation Factor Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for calcium gluconate

A12AA	Calcium
A12A	CALCIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for calcium gluconate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-002	Jun 15, 2017	AP	RX	Yes	Yes
Amneal	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216611-002	May 10, 2024	AP	RX	No	No
Nivagen Pharms Inc	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	213071-002	Oct 19, 2023	AP	RX	No	No
Amneal	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216611-003	May 10, 2024	AP	RX	No	No

Market Dynamics and Financial Trajectory for Calcium Gluconate

Last updated: July 28, 2025

Introduction

Calcium gluconate, a mineral supplement and electrolyte, holds a significant position within the pharmaceutical and healthcare sectors due to its critical role in calcium deficiency treatment, cardiac health management, and other medical applications. Its market dynamics are influenced by factors spanning clinical demand, regulatory landscape, manufacturing capabilities, and emerging technological advancements. Understanding these elements provides vital insights into its financial trajectory, enabling stakeholders to strategize effectively in a competitive global landscape.

Demand Drivers for Calcium Gluconate

Clinical and Medical Applications

Calcium gluconate’s primary use involves correcting calcium deficiencies caused by hypocalcemia, osteoporosis, and certain chronic conditions. It is also utilized in managing hyperkalemia, magnesium poisoning, and as an antidote for certain drug overdoses, notably in chemotherapy-induced nephrotoxicity or chelation therapy. The prevalence of osteoporosis and chronic calcium deficits, particularly among aging populations, drives consistent demand in both developed and emerging markets.

Healthcare Infrastructure and Population Aging

Global demographic shifts toward aging populations amplify the need for bone health management and calcium supplementation. Regions such as North America, Europe, and parts of Asia Pacific face increasing incidences of osteoporosis, osteoporosis-related fractures, and chronic medical conditions, all contributing to steady growth in calcium gluconate consumption.

Emerging Markets and Access Expansion

Rapid urbanization, increasing healthcare infrastructure, and government initiatives to improve healthcare access in countries like India, China, and Brazil are expanding the reach of essential pharmaceuticals, including calcium gluconate. This broadening access sustains demand growth within these regions.

Technological Advancements and Product Innovation

Innovative formulations—such as slow-release or liquid preparations—enhance bioavailability and patient compliance, expanding the market scope. Additionally, companion developments in diagnostic techniques facilitate precise calcium deficiency detection, potentially increasing therapeutic interventions.

Market Challenges and Constraints

Regulatory Landscape

Varying regulatory requirements across geographies impact market entry and product approval timelines. Compliance with pharmacopoeial standards and rigorous safety evaluations can delay product launches and inflate costs.

Price Fluctuations of Raw Materials

Raw material prices, especially for calcium salts and stabilizers, influence manufacturing costs. Price volatility and supply chain disruptions—exacerbated by geopolitical or environmental factors—pose risks to profit margins.

Competitive Market Dynamics

The presence of generic suppliers and the commoditized nature of calcium gluconate products intensify price competition, often leading to margin compression. Furthermore, manufacturer consolidation and strategic acquisitions influence market shares and pricing strategies.

Global Supply Chain Challenges

The COVID-19 pandemic highlighted vulnerabilities within pharmaceutical supply chains, with disruptions impacting production schedules and availability. Maintaining consistent supply is crucial to meet rising global demand.

Financial Trajectory and Market Outlook

Market Size and Growth Projections

The global calcium gluconate market was valued at approximately USD 200 million in 2022. According to industry reports, a compound annual growth rate (CAGR) of approximately 4-6% is anticipated through 2030, driven by increasing clinical applications and expanding healthcare infrastructure in emerging markets.

Key Regional Markets

• North America: Largest market share driven by high healthcare expenditure and prevalence of chronic conditions requiring calcium supplementation.
• Europe: Mature market with steady growth, adherence to stringent regulations, and emphasis on osteoporosis management.
• Asia Pacific: Fastest-growing market, with expanding healthcare systems, increased awareness, and rising prevalence of age-related calcium deficiencies.

Emerging Opportunities

• Niche Therapeutic Areas: Exploration of calcium gluconate in novel indications, such as managing hypocalcemia in cancer patients undergoing immunotherapy.
• Formulation Enhancements: Development of targeted, patient-friendly formulations can command premium pricing.
• Contract Manufacturing and OEM: Growth in contract manufacturing services provides avenues for pharma companies seeking efficient production solutions.

Impact of Regulatory and Reimbursement Policies

High regulatory standards necessitate continuous compliance investment, yet favorable reimbursement policies in key markets—like Medicare policies in the U.S.—support sustained demand. Price negotiations and reimbursement schemes influence overall revenue projections.

Risks and Uncertainties

Potential shifts include stricter regulations, raw material supply constraints, and competitive innovations that could alter market dynamics. Additionally, the emergence of new calcium delivery modalities or alternative therapies may affect market penetration.

Strategic Considerations for Stakeholders

• Investment in R&D: Focused innovation can differentiate products and expand therapeutic indications.
• Supply Chain Optimization: Building resilient supply lines mitigates risks associated with raw material shortages.
• Regulatory Intelligence: Staying ahead of evolving compliance requirements accelerates time-to-market.
• Market Penetration: Targeting underserved regions to capitalize on emerging market growth.
• Partnerships and Collaborations: Strategic alliances with healthcare providers and distributors amplify reach and market presence.

Key Takeaways

• The calcium gluconate market is expected to grow at a CAGR of 4-6% through 2030, driven mainly by aging populations, chronic disease prevalence, and healthcare infrastructure expansion.
• Regionally, North America and Europe dominate due to high healthcare spending and clinical adoption, but Asia Pacific presents significant growth opportunities.
• Market sustainability hinges on technological innovation, regulatory compliance, and raw material supply stability.
• Price competition within a largely commoditized market necessitates value-added formulations and strategic differentiation.
• Stakeholders must remain agile, leveraging R&D, regulatory intelligence, and supply chain resilience to maximize market share and profitability.

FAQs

1. What are the primary therapeutic uses of calcium gluconate?
Calcium gluconate is primarily used to treat hypocalcemia, manage cardiac arrhythmias related to calcium deficiency, serve as an antidote for magnesium overdose, and assist in certain chelation therapies.

2. How does demographic change impact calcium gluconate demand?
An aging global population increases the prevalence of osteoporosis and calcium deficiency-related conditions, thereby boosting demand for calcium gluconate products.

3. What are the key regulatory considerations for calcium gluconate manufacturers?
Manufacturers must adhere to pharmacopoeial standards, register products with relevant authorities (FDA, EMA, etc.), demonstrate safety and efficacy, and navigate varied approval timelines across jurisdictions.

4. Which regions are emerging markets for calcium gluconate?
Asia Pacific, especially China and India, represent rapidly expanding markets due to increasing healthcare infrastructure, awareness, and chronic disease prevalence.

5. How do raw material prices influence the calcium gluconate market?
Fluctuations in the costs of calcium salts, stabilizers, and excipients can significantly impact production costs, influencing pricing strategies and profit margins.

Sources

1. [1] Market Research Future. "Calcium Gluconate Market Research Report."
2. [2] Grand View Research. "Global Calcium Gluconate Market Analysis & Trends."
3. [3] World Health Organization (WHO). "Global Osteoporosis Fact Sheet."
4. [4] U.S. Food and Drug Administration (FDA). "Regulatory Guidelines for Mineral Supplements."
5. [5] Industry Expert Reports. "Emerging Trends in Pharmaceutical Raw Material Supply Chains."