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

Last Updated: March 26, 2026

CALCIUM GLUCONATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Calcium Gluconate, and when can generic versions of Calcium Gluconate launch?

Calcium Gluconate is a drug marketed by Amneal, B Braun Medical, Fresenius Kabi Usa, Nivagen Pharms Inc, Somerset, Hq Spclt Pharma, and Sagent. and is included in eight NDAs. There are two patents protecting this drug.

The generic ingredient in CALCIUM GLUCONATE 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

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

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CALCIUM GLUCONATE?
  • What are the global sales for CALCIUM GLUCONATE?
  • What is Average Wholesale Price for CALCIUM GLUCONATE?
Drug patent expirations by year for CALCIUM GLUCONATE
Drug Prices for CALCIUM GLUCONATE

See drug prices for CALCIUM GLUCONATE

Recent Clinical Trials for CALCIUM GLUCONATE

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 clinical trials

Pharmacology for CALCIUM GLUCONATE

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
Amneal CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611-001 May 10, 2024 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hq Spclt Pharma CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 210906-001 Oct 29, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sagent CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 219619-002 Dec 30, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 208418-003 Jun 15, 2017 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun Medical CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216541-001 Aug 21, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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

Last updated: January 15, 2026

Summary

Calcium Gluconate, a widely utilized mineral supplement and pharmaceutical agent, plays a vital role in managing hypocalcemia, cardiac arrhythmias, and calcium deficiencies. Its global market is shaped by factors including rising prevalence of osteoporosis, chronic kidney disease, and calcium deficiency-related conditions, alongside advances in pharmaceutical formulations and manufacturing technologies. This analysis elucidates current market dynamics, financial trajectories, key growth drivers, challenges, and strategic considerations for stakeholders over the next five years.


What Is Calcium Gluconate and Why Does It Matter in the Pharmaceutical Market?

Calcium Gluconate is a calcium salt of gluconic acid, commonly administered intravenously or orally to correct calcium deficiencies. Its pharmaceutical significance stems from:

  • Therapeutic Applications: Treatment of hypocalcemia, calcium channel blocker overdose, and as a supportive agent during calcium deficiency therapies.
  • Market Scope: Global pharmaceutical formulations, nutritional supplements, and emergency medicine segments.
  • Formulations: IV injections, oral tablets, and liquid solutions.

Global Market Overview and Size

Aspect Details Data/Source
Market Valuation (2022) Approx. USD 340 million MarketsandMarkets, 2022[1]
Expected CAGR (2023-2028) 4.8% Grand View Research, 2022[2]
Region with Largest Market Share North America (~40%) IQVIA, 2022[3]
Key Segment Drivers Calcium deficiency management, hospital use, chronic disease prevalence Industry Reports, 2022

Note: The growth is primarily driven by increased demand for calcium supplementation in aging populations and expanding emergency medical treatments.


Market Dynamics

What Are the Key Factors Driving Market Growth?

Drivers Description Impact Analysis
Rising Prevalence of Osteoporosis & Osteopenia Aging populations globally are experiencing increased fracture risk. Surge in calcium supplement prescriptions.
Chronic Kidney Disease (CKD) CKD patients often require calcium supplementation to manage mineral and bone disorder (CKD-MBD). Drives demand for calcium-based therapies.
Nutritional Supplementation Trends Growing awareness about bone health. Expansion of over-the-counter calcium supplement segment.
Advancements in Injectable Formulations Development of safer, more effective IV calcium preparations. Enhances hospital procurement and usage.
Regulatory Approvals & R&D New formulations, bioavailability improvements, and patent protections. Contribute to market expansion and profitability.

What Are the Challenges Limiting Market Expansion?

Challenges Description Impact
Pricing & Reimbursement Policies Variability across regions affects affordability. Limits utilization in lower-income markets.
Safety & Side Effects Excess calcium can cause hypercalcemia, kidney stones. Necessitates careful clinical monitoring, impacting sales volume.
Limited Awareness & Usage in Developing Countries Lack of healthcare infrastructure reduces access. Slows market growth in emerging economies.
Generic Competition Price erosion from generics. Compresses profit margins.

What Are Future Market Opportunities?

Opportunities Description Strategic Implications
Expanding Use in Neonatal & Pediatric Care Calcium gluconate in IV forms for neonatal hypocalcemia. Opens new clinical segments.
Integration with Multivitamin & Mineral Formulations Combining calcium with vitamin D, magnesium. Diversifies product offerings.
Emerging Markets Asia-Pacific, Latin America show growth potential. Investment in manufacturing & distribution.
Biotech & Novel Drug Delivery Liposomal calcium formulations for targeted delivery. Premium pricing and differentiation.

Financial Trajectory and Market Forecasts

Revenue Forecast (2023-2028)

Year Projected Market Value (USD million) CAGR Remarks
2023 356 Starting baseline.
2024 373 4.8% Incremental growth.
2025 391 4.8% Stronger demand in emerging markets.
2026 410 4.8% R&D innovations materialize.
2027 429 4.8% Market penetration deepens.
2028 449 4.8% Mature market dynamics.

Note: The trajectory aligns with global healthcare expenditure increases and aging demographics.

Major Revenue Contributor Segments

Segment Contribution % (2022) Growth Rate (2023-2028) Comments
Pharmaceutical Injectable Preparations 45% 5% Hospital and ER use.
Oral Supplements & Tablets 30% 4.5% Over-the-counter and nutrition.
Nutritional & Fortified Foods 15% 4% Emerging segment in fortification trends.
Research & Development 10% 6% Innovations in drug delivery.

Market Competition and Key Players

Company Market Share (%) Strategic Focus Notable Products Recent Developments
Fresenius Kabi 25% IV formulations & hospital supply Calcium Gluconate Injection Launch of new infusion systems, 2022.
Hospira (Pfizer) 20% Generic IV calcium products Calcium Gluconate IV Patent expiry, increased generic rivalry.
Baxter International 15% Custom formulations Calcium Gluconate IV solutions R&D investments, 2021-2022.
Other Players 40% Regional & niche markets Various formulations Focused on emerging markets.

Market Entry & Investment Strategies

  • Innovation in delivery methods, e.g., liposomal calcium, to command premium prices.
  • Partnerships with healthcare providers and government health agencies.
  • Geographic expansion into rapidly developing markets like India, Brazil, and Southeast Asia.
  • Manufacturing efficiencies to counteract price erosion from generics.

Regulatory Landscape and Policy Impacts

Region Key Policies Impact Examples
United States FDA oversight, Orphan Drug Designation, 21 CFR Part 312 Stringent approval, but accelerated pathways for certain formulations. FDA approvals for new formulations, 2022.
European Union EMA regulations, centralized procedures, post-market surveillance Product registration complexity necessitates compliance. Market authorizations for IV formulations, 2023.
Emerging Markets Varying standards, less strict controls Lower barriers for generics; potential compliance risks. Regulatory reforms in India (2019), China (2021).

Comparison: Calcium Gluconate vs. Other Calcium Salts

Parameter Calcium Gluconate Calcium Chloride Calcium Carbonate Calcium Citrate
Bioavailability Moderate High (IV) Moderate High
Safety Profile Well-tolerated Risk of vein irritation (IV) Safe, gastric absorption Better tolerated in GI tract
Cost Moderate Lower (generics) Low Moderate
Preferred Use Cases Hypocalcemia, IV therapy Emergency, severe hypocalcemia Oral supplementation Alternative for those intolerant to calcium carbonate

Deep Dive: FAQs in the Calcium Gluconate Market

1. What are the primary drivers of calcium gluconate demand?

The demand is driven mainly by aging populations, osteoporosis prevalence, chronic kidney disease management, emergency medical needs, and increasing health-consciousness leading to over-the-counter supplement use.

2. How do regulatory policies influence market expansion?

Stricter regulations in developed regions ensure safety and quality but can delay product approvals, impacting market entry. Conversely, less regulated emerging markets present growth opportunities but pose compliance risks.

3. What innovations are expected to shape the future of calcium gluconate formulations?

Liposomal encapsulation, combination doxy formulations with vitamin D, smart infusion systems, and sustained-release oral formulations are poised to enhance efficacy and patient compliance.

4. How significant is the threat of generics and price competition?

Very high; many manufacturers produce calcium gluconate formulations, leading to thin profit margins. Investment in R&D and formulation differentiation are critical to sustaining competitive advantage.

5. What are the key regional growth prospects?

Asia-Pacific, Latin America, and Africa offer high growth potential due to expanding healthcare infrastructure, increased disease prevalence, and rising health awareness.


Key Takeaways

  • Consistent Growth Trajectory: The calcium gluconate market is projected to grow at an approximate CAGR of 4.8% through 2028, driven by demographic and clinical trends.
  • Market Drivers & Opportunities: Increasing prevalence of osteoporosis, CKD, and nutritional awareness boost demand, especially for injectable and combination formulations.
  • Competitive Dynamics: Major players dominate the hospital IV segment, with innovation and regional expansion as strategic imperatives.
  • Regulatory & Pricing Challenges: Navigating regulatory landscapes and competitive pricing (generic erosion) remain critical for profitability.
  • Future Outlook: Technological advances, emerging market penetration, and expanded clinical applications will fuel sustained growth.

Stakeholders should prioritize R&D, strategic market entry, and regulatory compliance to capitalize on evolving opportunities in calcium gluconate’s landscape.


References

[1] MarketsandMarkets, 2022. Calcium Gluconate Market by Application & Region.
[2] Grand View Research, 2022. Pharmaceutical Calcium Market Size & Trends.
[3] IQVIA, 2022. Global Pharmaceutical Market Insights.

More… ↓

⤷  Start Trial

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.