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Last Updated: December 22, 2024

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - Generic Drug Details

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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 J And J Consumer Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-three 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:	23
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

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

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Glossary

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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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Subscribe	⤷ Subscribe
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Subscribe	⤷ Subscribe
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Subscribe	⤷ Subscribe
J And J Consumer Inc	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE Market Analysis and Financial Projection Experimental

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

Introduction to Antacids Market

The antacids market, which includes medications like Calcium Carbonate; Famotidine; Magnesium Hydroxide, is experiencing significant growth driven by increasing gastrointestinal issues and changing lifestyle choices. Here, we will delve into the market dynamics and financial trajectory of this specific drug combination.

Global Antacids Market Overview

The global antacids market was valued at USD 7.63 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2030, reaching nearly USD 10.39 billion by the end of the forecast period[1].

Key Drivers of the Market

Rising Prevalence of Gastrointestinal Issues

The growing prevalence of gastrointestinal diseases such as Gastroesophageal Reflux Disease (GERD) and acid reflux is a major driver of the antacids market. According to a report, more than 20.5% of Americans suffered from acid reflux and heartburn in 2017[1].

Aging Population

The increasing number of elderly individuals, projected to rise from 703 million in 2019 to 1.5 billion by 2050, contributes to the demand for antacids as this demographic is more prone to gastrointestinal issues[1].

Unhealthy Lifestyle Choices

Unhealthy lifestyle choices, including poor diet and lack of physical activity, increase acidity and drive the demand for antacids.

Product Approvals and Innovations

Recent product approvals, such as the FDA approval of glycopyrrolate orally disintegrating tablets in December 2021, and the introduction of generic versions of popular antacids, like omeprazole and famotidine, are expected to boost market growth[1].

Market Segmentation

By Dosage Form

The antacids market is segmented by dosage form, including tablets, liquids, powders, and others. The combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide is commonly available in chewable tablet form, which is convenient for quick relief from heartburn and acid indigestion[1][4].

By Drug Class

The Proton Pump Inhibitors (PPIs) segment is expected to grow at the highest CAGR during the forecast period. However, the combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide falls under the H2 antagonists and acid neutralizers categories, which also see significant demand[1].

Regional Insights

North America

North America, particularly the United States, dominates the global antacid market. Factors such as increasing cases of GI diseases, advanced healthcare infrastructure, and the presence of prominent market players contribute to this dominance[4].

Asia Pacific

The Asia Pacific region is anticipated to surge at the highest CAGR over the forecast period, driven by changing lifestyle and food consumption patterns, an expanding pharmaceutical industry, and rising demand for Over-The-Counter (OTC) drugs[4].

Financial Trajectory

Market Size and Growth

The global antacids market, which includes the Calcium Carbonate; Famotidine; Magnesium Hydroxide combination, is expected to grow significantly. The market size is projected to increase from USD 7.63 billion in 2023 to nearly USD 10.39 billion by 2030[1].

Revenue Streams

Revenue streams for this drug combination are primarily driven by OTC sales, retail pharmacy sales, and online pharmacy sales. The convenience of OTC availability and the increasing popularity of online pharmacies are expected to contribute to the financial growth of this market segment[1][4].

Product Specifics

Active Ingredients and Mechanism

The combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide works by quickly lowering stomach acid and blocking acid release. Calcium carbonate and magnesium hydroxide are antacids that neutralize stomach acid, while famotidine is an H2 receptor blocker that reduces acid production in the stomach[3][5].

Dosage and Administration

The usual adult dose for dyspepsia is 800 mg of calcium carbonate, 10 mg of famotidine, and 165 mg of magnesium hydroxide, taken orally once a day as needed. Tablets should be completely chewed before swallowing[5].

Challenges and Opportunities

High Sodium Content and Heart Disease

One of the challenges for antacids with high sodium content is the potential issue for individuals with heart disease. However, the combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide does not typically contain high sodium levels, making it a safer option for many users[1].

Adverse Drug Reactions

Famotidine can interact with other medications, such as atazanavir and certain azole antifungals, by reducing stomach acid and affecting their absorption. This necessitates careful consideration and consultation with healthcare professionals before use[3].

Key Takeaways

The global antacids market is expected to grow at a CAGR of 4.5% from 2024 to 2030.
The combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide is a significant player in this market, offering quick relief from heartburn and acid indigestion.
North America and the Asia Pacific region are key markets, driven by lifestyle changes and the prevalence of GI diseases.
Product approvals and innovations are crucial for market growth.
The drug combination works by neutralizing and blocking stomach acid, making it a popular OTC choice.

FAQs

What is the primary use of the combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide?

The primary use of this combination is to treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion).

How does the combination of Calcium Carbonate; Famotidine; Magnesium Hydroxide work?

Calcium carbonate and magnesium hydroxide quickly lower stomach acid, while famotidine blocks acid release in the stomach by reducing acid production.

What are the common dosage instructions for this medication?

The usual adult dose is 800 mg of calcium carbonate, 10 mg of famotidine, and 165 mg of magnesium hydroxide, taken orally once a day as needed. Tablets should be completely chewed before swallowing.

Can this medication interact with other drugs?

Yes, famotidine can interact with other medications such as atazanavir and certain azole antifungals by reducing stomach acid and affecting their absorption.

What are the potential side effects or contraindications of this medication?

Contraindications include hypersensitivity to any of the active components, trouble/pain swallowing food, vomiting with blood, or bloody/black stools. Safety and efficacy have not been established in patients younger than 12 years.

Sources

Maximize Market Research: Antacids Market - Global Industry Analysis and Forecast (2024-2030)
FDA: Draft Guidance on Calcium Carbonate; Famotidine; Magnesium Hydroxide
HealthLink BC: Famotidine/Calcium Carbonate/Magnesium Hydroxide - Chewable
The Insight Partners: Antacid Market Size, Share and Growth Analysis by 2027
Drugs.com: Calcium Carbonate / Famotidine / Magnesium Hydroxide Dosage

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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. 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.