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-six 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:	26
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
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
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes

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	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
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,075,114*PED
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	5,817,340*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,229,137*PED

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

Last updated: February 19, 2026

What Are the Key Market Drivers?

The market for calcium carbonate, famotidine, and magnesium hydroxide is shaped by factors including aging populations, prevalence of gastrointestinal and osteoporosis conditions, and advances in manufacturing processes.

Calcium Carbonate

• Major use: dietary supplements, antacids, and fillers in pharmaceuticals.
• Growth drivers: rising osteoporosis cases, increasing supplement consumption, and infrastructure expansion in emerging markets.
• Market size: valued at approximately USD 4.8 billion in 2022, with a compound annual growth rate (CAGR) of 5.2% (PMR, 2023).

Famotidine

• Major use: gastric acid reduction, treatment of gastroesophageal reflux disease (GERD), peptic ulcers.
• Market influence: prevalence of acid-related disorders, barriers to prescription in some markets, and availability of generics.
• Size: estimated at USD 1.2 billion in 2022, with a CAGR of 3.8% (Grand View Research, 2023).

Magnesium Hydroxide

• Main applications: antacid, laxative, magnesium supplementation.
• Market trends: increased consumer awareness about gastrointestinal health, and generic production making it accessible.
• Valuation: around USD 300 million in 2022, with a CAGR of 4.5% (Research and Markets, 2023).

How Do Regulatory Policies Influence Market Trajectory?

Regulatory frameworks, particularly regarding safety and manufacturing standards, significantly impact market growth for these APIs.

• Calcium carbonate: Approved as a supplement and food additive globally, with moderate regulatory hurdles.
• Famotidine: Post-2019, some markets reclassified famotidine following concerns over contamination, but most regions maintain acceptance for over-the-counter and prescription use.
• Magnesium hydroxide: Broadly classified as an over-the-counter drug; regulatory changes are minimal but include standards for purity and labeling.

What Are Competitive and Supply Chain Trends?

Blocks to market expansion include raw material availability, production costs, and patent expirations.

Raw Material Supply

• Calcium carbonate: Obtained from mined limestone and marble; supply chain disruptions in mining regions impact pricing.
• Famotidine: Synthesis relies on complex intermediates; manufacturing capacity concentrated in Asia.
• Magnesium hydroxide: Derived from seawater or brine; susceptible to fluctuations in mineral extraction.

Patent and Competition

• Famotidine: Patent expiry in 2021 in many jurisdictions has prompted a surge in generics.
• Calcium carbonate & magnesium hydroxide: No recent patent limitations; high OTC availability encourages multiple manufacturers.

What Are Revenue and Profitability Projections?

Forecasts anticipate steady growth driven by increasing demand and generic competition:

Compound	Market Size (2022)	Predicted CAGR	Expected Market Size (2027)
Calcium carbonate	USD 4.8 billion	5.2%	USD 6.3 billion
Famotidine	USD 1.2 billion	3.8%	USD 1.6 billion
Magnesium hydroxide	USD 300 million	4.5%	USD 390 million

Profit margins remain variable; high OTC sales limit price setting power, especially for calcium carbonate and magnesium hydroxide. Generics compress profit margins for famotidine.

What Risks and Opportunities Exist?

Risks

• Regulatory constraints can delay approvals.
• Raw material price volatility impacts manufacturing costs.
• Market saturation from generic competition.

Opportunities

• Increasing health awareness fosters sustained demand.
• New formulations for targeted delivery.
• Expansion in emerging markets with rising middle class incomes.

Summary of Market Outlook

Aspect	Summary
Market size (2022)	USD 6.3 billion across the three compounds
Growth rate (2022–2027)	Approximately 4.7% combined CAGR
Key growth areas	Emerging markets, OTC sales, developmental formulations
Challenges	Raw material supply, regulatory delays, patent expirations

Key Takeaways

• The market for calcium carbonate, famotidine, and magnesium hydroxide is growing driven by health trends and demographic shifts.
• Generic competition, especially for famotidine, influences revenue margins.
• Raw material supply chain issues pose risks, but new formulation strategies and market expansion can offset challenges.
• Regulatory standards, while generally stable, require ongoing compliance management to avoid delays.
• The market offers incremental growth opportunities in emerging markets and niche formulations.

FAQs

1. What is the main driver for calcium carbonate market growth?
   The increase in osteoporosis diagnoses and supplement consumption.

2. How has famotidine’s patent expiry affected its market?
   It led to increased generic availability, reducing prices and profit margins.

3. Are supply chain issues significant for magnesium hydroxide?
   Yes. Dependence on seawater or brine extraction makes supply sensitive to environmental and geopolitical factors.

4. What regulatory challenges impact these APIs?
   Safety standards, manufacturing quality controls, and approvals for new formulations.

5. How does demographic change influence these markets?
   Aging populations elevate demand for osteoporosis treatments and gastrointestinal health products.

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References

[1] Persistent Market Research. (2023). Global Calcium Carbonate Market Report.
[2] Grand View Research. (2023). Famotidine Market Size & Trends.
[3] Research and Markets. (2023). Magnesium Hydroxide Market Analysis.