CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - Generic Drug Details

What are the generic sources for calcium carbonate; famotidine; magnesium hydroxide and what is the scope of patent protection?

Calcium carbonate; famotidine; magnesium hydroxide is the generic ingredient in two branded drugs marketed by Perrigo R And D and Kenvue Brands, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-five suppliers are listed for this compound.

Summary for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	25
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
DailyMed Link:	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE at DailyMed

Pharmacology for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Drug Class	Calculi Dissolution Agent Histamine-2 Receptor Antagonist Osmotic Laxative
Mechanism of Action	Histamine H2 Receptor Antagonists Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Anatomical Therapeutic Chemical (ATC) Classes for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

A02AA	Magnesium compounds
A02A	ANTACIDS
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02AC	Calcium compounds
A02A	ANTACIDS
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

G04BX	Other urologicals
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEPCID COMPLETE	Chewable Tablets	calcium carbonate; famotidine; magnesium hydroxide	800 mg/10 mg/ 165 mg (OTC)	020958	1	2004-11-01

US Patents and Regulatory Information for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	077355-001	Feb 6, 2008		OTC	No	No
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	204782-001	Aug 29, 2016		DISCN	No	No

Expired US Patents for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,989,588*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	4,283,408*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	6,814,978*PED

Market Dynamics and Financial Trajectory for Calcium Carbonate, Famotidine, and Magnesium Hydroxide

Last updated: July 30, 2025

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Introduction

The global pharmaceutical landscape is notably influenced by the market performance and developmental prospects of active pharmaceutical ingredients (APIs) such as calcium carbonate, famotidine, and magnesium hydroxide. These compounds, primarily used in gastrointestinal and cardiovascular therapeutics, have experienced varying market trajectories driven by technological innovations, regulatory shifts, consumer demand, and competitive dynamics. This comprehensive analysis evaluates the current market dynamics and projects the financial trajectory for these key pharmaceuticals.

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Market Overview

Calcium Carbonate: Widely utilized as an antacid, calcium supplement, and industrial filler, calcium carbonate commands a substantial share in both pharmaceutical and non-pharmaceutical markets. The global demand exceeds 60 million tons annually, driven by preferences for over-the-counter (OTC) products and dietary supplements. The pharmaceutical sector alone accounts for a significant segment, especially within osteoarthritis treatments and osteoporosis management.

Famotidine: Belonging to the class of histamine H2 receptor antagonists, famotidine is primarily prescribed for acid-related gastrointestinal disorders such as GERD, peptic ulcers, and Zollinger-Ellison syndrome. Initially launched in the 1980s, famotidine’s legacy has been complemented by newer drugs, but it retains steady demand due to cost-effectiveness and familiarity among healthcare providers.

Magnesium Hydroxide: Known as milk of magnesia, it is a common OTC remedy for indigestion, acid reflux, and constipation. Despite the emergence of novel therapies, magnesium hydroxide maintains a resilient position owing to its affordability and safety profile.

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Market Drivers

Calcium Carbonate

• Aging Demographics & Osteoporosis: Rising aging populations globally amplify demand for calcium-based supplements, particularly in North America and Europe, where osteoporosis prevalence is high.
• Dietary Supplement Trends: Increased health consciousness fuels consumption in emerging markets, supported by rising disposable incomes.
• Industrial Applications: Expanding use as a filler in plastics and paper enhances market stability, indirectly benefitting pharmaceutical-grade calcium carbonate.
• Regulatory Environment: Stricter manufacturing standards boost quality assurance but pose barriers to smaller producers.

Famotidine

• Generic Competition & Pricing Dynamics: Patent expirations have led to a surge in generic famotidine, intensifying price competition.
• Shift Toward PPIs: Proton pump inhibitors (PPIs) like omeprazole have encroached on famotidine’s market share, yet famotidine remains relevant due to lower costs.
• COVID-19 Impact & Repurposing: Early studies suggesting famotidine’s potential in COVID-19 treatment temporarily elevated demand, although these effects have waned.
• Regulatory & Formulation Advances: Efforts to develop new formulations (e.g., IV, sustained-release) could extend market viability.

Magnesium Hydroxide

• Consumer Preference & OTC Accessibility: Its familiarity and safety promote consistent OTC sales globally.
• Innovative Delivery Forms: Liquid formulations and combination products with other antacids enhance consumer appeal.
• Competition & Alternatives: Dominance by other antacids and PPIs remains a challenge, although cost advantages sustain its market share.
• Global Health Trends: Increasing gastrointestinal disorder prevalence supports steady demand.

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Market Challenges

• Regulatory Scrutiny: Stringent quality control, especially for calcium carbonate supplements, raises compliance costs.
• Pricing Pressures: High competition from generics compress profit margins, especially for famotidine.
• Market Saturation: Mature markets in North America and Europe experience plateauing growth, shifting focus toward emerging market expansion.
• Innovation & R&D Investment: Need for formulation improvements to meet patient compliance and safety standards demands significant R&D investments.

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Financial Trajectory and Market Projections

Calcium Carbonate

The calcium carbonate market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2022 to 2027, driven by increasing supplement consumption and industrial use expansion. The burgeoning elderly population in Asia-Pacific, particularly in China and India, catalyzes regional growth prospects. Revenue estimates forecast a global market size surpassing USD 4.8 billion by 2027, with North America and Asia-Pacific as key contributors.

Famotidine

The famotidine market is expected to witness a moderate CAGR of around 3% over the same period, stabilizing due to generic market saturation and competition from PPIs. Despite this, annual revenues are anticipated to average USD 0.8–1 billion, sustained by cost-sensitive healthcare systems. Innovations such as intravenous formulations and combination therapies could offset declines in tablet sales, potentially opening new revenue streams.

Magnesium Hydroxide

Projected to grow at approximately 3.5% CAGR through 2027, magnesium hydroxide’s demand remains resilient in OTC markets, especially within emerging economies. The global market could reach USD 1.2 billion, benefiting from increasing gastrointestinal disorder prevalence. Strategic partnerships and formulation innovations are likely to enhance market penetration.

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Emerging Opportunities and Strategic Outlook

Personalized Medicine & Delivery Innovations: Next-generation formulations, including sustained-release and novel delivery systems, will promote growth and differentiate products.

Biopharmaceutical Partnerships: Collaborations for biosimilar and generic development will reduce R&D costs and accelerate market entry.

Geographic Expansion: Targeting underpenetrated markets in Latin America, Africa, and Southeast Asia offers significant growth potential, driven by increasing healthcare infrastructure.

Regulatory & Quality Standards: Investing in compliance and quality assurance will bolster brand reputation and competitive positioning.

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Conclusion

The market dynamics of calcium carbonate, famotidine, and magnesium hydroxide reflect a landscape marked by incremental growth, competitive pressures, and evolving consumer preferences. Calcium carbonate benefits from diversified applications and demographic shifts, projecting steady growth in supplements and industrial sectors. Conversely, famotidine’s trajectory faces headwinds from generic competition and PPI encroachment, although niche formulary and formulation innovations offer avenues for sustained revenue. Magnesium hydroxide's OTC resilience and expanding health awareness underpin stable demand, with potential uplift from emerging markets.

Strategic investments in product innovation, geographic expansion, and regulatory compliance will be crucial for companies looking to optimize revenue and market share in this mature yet resilient segment.

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Key Takeaways

• Calcium Carbonate offers substantial growth driven by aging populations and health-conscious consumers, with a focus on supplement and industrial use expansion.
• Famotidine faces pricing and competition challenges but can sustain revenues through formulation innovations and targeting emerging markets.
• Magnesium Hydroxide maintains steady OTC sales, with growth prospects bolstered by rising gastrointestinal health awareness worldwide.
• Market players must prioritize innovation, regulatory compliance, and geographic diversification to navigate saturation and competitive pressures.
• Emerging trends such as personalized delivery systems and biosimilar collaborations present new revenue opportunities.

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FAQs

1. What are the primary drivers of calcium carbonate market growth?
   Aging demographics, dietary supplement trends, and industrial applications primarily drive calcium carbonate's market expansion.

2. How does patent expiry impact famotidine's market performance?
   Patent expirations have led to increased generic competition, reducing prices and profit margins but also expanding accessibility and volume sales.

3. What factors favor magnesium hydroxide's continued demand?
   Its affordability, safety profile, OTC availability, and increasing prevalence of gastrointestinal disorders sustain magnesium hydroxide’s steady demand.

4. Are there significant regulatory risks associated with these APIs?
   Yes; stringent quality standards and manufacturing regulations can increase compliance costs and pose barriers, especially for manufacturers in emerging markets.

5. What strategies can pharmaceutical companies adopt for future growth in this sector?
   Prioritizing formulation innovation, expanding into emerging markets, ensuring regulatory compliance, and forming strategic partnerships can enhance growth prospects.

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Sources Cited:

1. [1] MarketWatch. "Global Calcium Carbonate Market." 2022.
2. [2] Grand View Research. "Famotidine Market Analysis & Trends." 2023.
3. [3] ResearchAndMarkets. "Magnesium Hydroxide Market Forecast." 2022.
4. [4] Statista. "Pharmaceutical Industry Reports." 2023.
5. [5] WHO. "Global Trends in Aging and Healthcare." 2021.