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 Inc, 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. Eleven 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:	11
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	30
Patent Applications:	6,514
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
Ascension Genesys Hospital	Phase 2
Aurora Health Care	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

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 IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-004	Jun 17, 2021	AP	RX	Yes	Yes
Amneal	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	217174-002	Sep 5, 2023	AP	RX	No	No
B Braun Medical Inc	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	216541-001	Aug 21, 2023	AP	RX	No	No
Hq Spclt Pharma	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	210906-002	Oct 29, 2018		RX	Yes	Yes			Y
Amneal	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	217174-001	Sep 5, 2023	AP	RX	No	No
Hq Spclt Pharma	CALCIUM GLUCONATE IN SODIUM CHLORIDE	calcium gluconate	SOLUTION;INTRAVENOUS	210906-001	Oct 29, 2018		RX	Yes	Yes			Y
Fresenius Kabi Usa	CALCIUM GLUCONATE	calcium gluconate	SOLUTION;INTRAVENOUS	208418-001	Jun 15, 2017	AP	RX	Yes	Yes

Calcium gluconate Market Analysis and Financial Projection Experimental

Calcium Gluconate Market Dynamics and Financial Trajectory

Market Overview

The calcium gluconate market is experiencing significant growth, driven by several key factors. Calcium gluconate, a derivative of gluconic acid, is widely used in various industries, including pharmaceuticals, food and beverages, and nutraceuticals. Here is a comprehensive look at the market dynamics and financial trajectory of calcium gluconate.

Market Size and Growth

The global calcium gluconate market has been expanding rapidly. As of 2023, the market size was valued at USD 98.72 billion and is projected to reach around USD 179.31 billion by 2033, growing at a CAGR of 6.15% from 2024 to 2033[3].

Regional Market Performance

• North America: This region dominates the global calcium gluconate market, primarily due to its extensive use in pharmaceuticals to treat calcium deficiency, osteoporosis, and other bone-related conditions. The U.S. market alone surpassed USD 28.14 billion in 2023 and is expected to grow to USD 51.78 billion by 2033 at a CAGR of 6.28%[3].
• Asia Pacific: This region is the fastest-growing market for calcium gluconate, driven by increasing consumer demand for healthy products and a significant portion of the population suffering from calcium deficiency. Countries like China, India, and Japan are key drivers of this growth[3][5].
• Europe: The European market was valued at USD 26.65 billion in 2023 and is projected to expand to USD 49.31 billion by 2033, growing at a CAGR of 6.28%[3].

Market Drivers

Increasing Demand for Health Supplements

The growing aging population and the increasing prevalence of calcium deficiency worldwide are major drivers of the market. Over 3.5 million people globally are at risk of calcium deficiency, leading to a higher demand for calcium gluconate as a supplement[3].

Pharmaceutical Applications

Calcium gluconate is widely used in the pharmaceutical industry for treating conditions such as hypocalcemia, cardiac arrest, and cardiotoxicity due to hyperkalemia or hypermagnesemia. Its use in managing β-blocker toxicity, calcium channel blocker toxicity, and magnesium toxicity also contributes to market growth[4].

Food and Beverage Sector

The approval of GRAS (Generally Recognized as Safe) status has increased the use of calcium gluconate as a food additive. It is used as a bulking agent, emulsifier, and thickening agent, further boosting its demand in the food and beverage segment[1].

Market Segmentation

By Grade

• Pharmaceutical Grade: This segment accounts for the largest share of the market due to its extensive use in medical treatments.
• Food Grade: Expected to grow the fastest, driven by rising demand for food-grade calcium gluconate products[3].

By Form

• Powder: Dominates the market due to its ease of use in various food products and beverages.
• Liquid: The fastest-growing segment, preferred for its quick absorption and ease of use, especially in emergency medical situations[3].

By Function

• Calcium Supplement: Key function driving market growth.
• Bone Health: Another significant function, particularly in treating osteoporosis and other bone-related conditions.
• Antacid and Skincare: Also used in these applications, contributing to market diversity[3].

Market Restraints

Side Effects

Excessive consumption of calcium gluconate can lead to side effects such as nausea, vomiting, constipation, decreased appetite, and dry mouth. These adverse effects act as a restraint for the market[1][4].

Regulatory Constraints

Different food regulatory constraints that hinder product formulation and labeling requirements also affect market growth[1].

Key Players and Market Concentration

The market is characterized by low concentration, with several major players such as Fresenius Kabi and HQ Specialty Pharma Corporation. These companies are innovating and expanding their product lines to meet the growing demand[1][2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the calcium gluconate market. While there was an initial disruption in supply chains, the increased focus on health and wellness during the pandemic has driven up demand for dietary supplements, including calcium gluconate[1][5].

Financial Projections

The financial trajectory of the calcium gluconate market is robust, with a projected CAGR of 6.15% from 2024 to 2033. Here are some key financial projections:

• Global Market Size: Expected to reach USD 179.31 billion by 2033 from USD 98.72 billion in 2023[3].
• Regional Growth: North America and Asia Pacific are expected to be the leading regions in terms of revenue growth[3].

Technological Innovations

Continuous technological innovations are improving the efficiency and effectiveness of calcium gluconate products. These innovations are enhancing the product's usability and expanding its applications across various industries[3].

Consumer Trends

Increasing consumer awareness about health and the rising disposable income are driving the demand for calcium gluconate. The trend towards healthier lifestyles and the use of food additives and supplements to address calcium needs are significant consumer trends influencing the market[3].

"Over 3.5 million people worldwide are at risk of calcium deficiency, which can lead to various medical issues, ranging from mild symptoms to potentially severe or chronic conditions"[3].

Key Takeaways

• The global calcium gluconate market is growing at a CAGR of 6.15% from 2024 to 2033.
• North America dominates the market, while Asia Pacific is the fastest-growing region.
• The market is driven by increasing demand for health supplements, pharmaceutical applications, and use in the food and beverage sector.
• Side effects and regulatory constraints are key restraints.
• Technological innovations and consumer trends towards healthier lifestyles are driving market growth.

Frequently Asked Questions (FAQs)

1. What are the primary applications of calcium gluconate?

Calcium gluconate is primarily used in the pharmaceutical industry to treat conditions such as hypocalcemia, cardiac arrest, and cardiotoxicity. It is also used in the food and beverage sector as a bulking agent, emulsifier, and thickening agent[1][4].

2. Which region is the fastest-growing market for calcium gluconate?

The Asia Pacific region is the fastest-growing market for calcium gluconate, driven by increasing consumer demand for healthy products and a significant portion of the population suffering from calcium deficiency[3][5].

3. What are the common side effects of calcium gluconate?

Common side effects include nausea, vomiting, constipation, decreased appetite, and dry mouth. Extravasation from intravenous sites can also lead to tissue necrosis and other severe complications[1][4].

4. How does the GRAS status impact the market for calcium gluconate?

The approval of GRAS status has increased the use of calcium gluconate as a food additive, enhancing its demand in the food and beverage segment[1].

5. What is the projected market size of calcium gluconate by 2033?

The global calcium gluconate market is projected to reach around USD 179.31 billion by 2033, growing at a CAGR of 6.15% from 2024 to 2033[3].

Sources:

1. Mordor Intelligence - Calcium Gluconate Market Size - Mordor Intelligence
2. FDA - 210906Orig1s000 - accessdata.fda.gov
3. Precedence Research - Calcium Gluconate Market Size to Surpass USD 179.31 Bn by 2033
4. StatPearls - Calcium Gluconate | Treatment & Management | Point of Care
5. Mordor Intelligence - Calcium Gluconate Market Size & Share Analysis - Mordor Intelligence