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Last Updated: December 28, 2025

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE Drug Patent Profile


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When do Famotidine, Calcium Carbonate, And Magnesium Hydroxide patents expire, and when can generic versions of Famotidine, Calcium Carbonate, And Magnesium Hydroxide launch?

Famotidine, Calcium Carbonate, And Magnesium Hydroxide is a drug marketed by Perrigo R And D and is included in two NDAs.

The generic ingredient in FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

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Summary for FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
Drug patent expirations by year for FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

US Patents and Regulatory Information for FAMOTIDINE, CALCIUM CARBONATE, AND 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for gastrointestinal (GI) therapeutics has experienced significant shifts, driven by evolving consumer preferences, regulatory changes, and scientific advancements. Central to the GI drug market are medications like famotidine, calcium carbonate, and magnesium hydroxide—each with distinct pharmacological profiles but often overlapping in indications such as acid-related disorders. This analysis explores the current market dynamics and anticipated financial trajectories of these drugs, offering insights valuable for stakeholders in pharmaceutical investment, R&D, and commercialization.


1. Market Overview and Historical Context

Famotidine

Famotidine, a potent histamine-2 receptor antagonist (H2RA), historically enjoyed wide utilization in treating GERD, peptic ulcers, and Zollinger-Ellison syndrome. Its market peaked prior to 2019, with global sales exceeding USD 1.2 billion annually [1]. However, the advent of proton pump inhibitors (PPIs) and subsequent safety concerns regarding long-term PPI use led to a decline in famotidine prescriptions.

Notably, in 2020, amid the COVID-19 pandemic, famotidine garnered renewed attention as a potential therapeutic adjunct, although clinical evidence remains inconclusive. In 2020, the drug faced a significant setback in some markets with the withdrawal of ranitidine, another H2RA, elevating famotidine's importance temporarily.

Calcium Carbonate

Calcium carbonate remains one of the most widely used over-the-counter (OTC) antacids globally. Its low cost, widespread availability, and dual use as a dietary supplement for osteoporosis underpin a largely stable market segment. The global calcium supplements market was valued at approximately USD 5.9 billion in 2021, expanding modestly at a compound annual growth rate (CAGR) of 4.2% through 2028 [2].

Calcium carbonate's primary application is symptomatic relief of indigestion and heartburn, with additional use in maintaining bone health. Its OTC status and high brand loyalty support consistent sales, though the market faces competitive pressure from alternative antacids and dietary supplements.

Magnesium Hydroxide

Magnesium hydroxide, marketed commonly as milk of magnesia, functions as both an antacid and laxative. The global laxatives market alone was valued at over USD 4.5 billion in 2021, with magnesium hydroxide accounting for a significant share due to its efficacy and safety profile. The segment exhibits steady growth, with a CAGR estimated at 3.8% [3].

Magnesium hydroxide's use is particularly prevalent in geriatric populations and patients with renal impairment, supporting consistent demand. The OTC nature of many formulations facilitates high accessibility, but competitive dynamics with other laxatives influence pricing and market share.


2. Market Dynamics Shaping the Industry

2.1 Shifts in Clinical Guidelines and Regulatory Environment

Regulatory agencies such as the FDA and EMA continuously update guidelines for GI medications based on emerging safety data. The 2020–2021 recall of ranitidine due to NDMA contamination highlighted the importance of manufacturing quality and prompted increased scrutiny of older drugs like famotidine. This environment fosters a cautious approach toward repurposing or expanding indications for existing drugs.

Moreover, formal recommendations favoring PPIs over H2RAs for acid suppression have constrained famotidine’s market share. Nevertheless, safety concerns about PPI long-term use have renewed interest in alternative therapies, potentially opening pathways for famotidine repositioning.

2.2 Competitive Landscape

  • Famotidine: The decline in famotidine sales correlates with PPI dominance. However, a resurgence in research exploring famotidine's anti-inflammatory properties during COVID-19 increased academic and commercial interest.

  • Calcium Carbonate: Dominated predominantly by OTC formulations, with major players including GlaxoSmithKline, Bayer, and generic manufacturers. Innovation in formulations or adjunct health benefits (e.g., combination with vitamin D) could influence growth.

  • Magnesium Hydroxide: Competitive pressures from alternative laxatives, such as polyethylene glycol and stimulant laxatives, limit growth but sustain steady demand due to established efficacy.

2.3 Technological and Formulation Innovations

Advances in drug delivery systems, including controlled-release formulations and combination therapies, influence market dynamics. For example, dual-action antacid–laxative products or calcium-magnesium combinations aim to optimize therapeutic effects and consumer appeal.

2.4 Customer Demographics and Usage Trends

The aging global population and increasing prevalence of GERD and peptic ulcer disease sustain demand across all three drugs:

  • Famotidine: Potential niche resurgence among patients seeking alternatives to PPIs.
  • Calcium Carbonate and Magnesium Hydroxide: Routine OTC use across demographics, with growth driven by increasing health awareness.

3. Financial Trajectory and Market Forecasts

3.1 Revenue Projections

  • Famotidine: Market revenue declined sharply after 2019 but shows signs of stabilization due to increased research interest and potential repositioning. The market for famotidine is projected to grow modestly at a CAGR of 2–3% over the next five years, driven by emerging COVID-19-related applications and an aging population seeking alternatives to PPIs [4].

  • Calcium Carbonate: Sustains a stable trajectory with a CAGR of approximately 3.5–4% through 2028, aligning with the broader dietary supplement and OTC medication markets. Innovations, such as patient-friendly dosage forms and combination products, could marginally boost sales.

  • Magnesium Hydroxide: Exhibits steady growth at a CAGR of 3–4%. Market expansion factors include increased awareness of natural and mineral-based therapies and continuous demand within eldercare sectors.

3.2 Investment and R&D Outlook

Patent expirations and generic proliferation have exerted downward pressure on drug prices, prompting firms to prioritize reformulations, delivery innovations, or novel indications. For example, companies exploring famotidine as an anti-inflammatory or antiviral agent could carve new revenue streams.

The OTC segments for calcium carbonate and magnesium hydroxide remain investor-friendly, with low regulatory barriers and consistent consumer demand. Smaller biotech firms and OTC manufacturers are investing in novel delivery mechanisms and supplemental uses to sustain growth.

3.3 Geographical Market Trends

Developed markets (North America, Europe) dominate current sales, yet emerging markets (Asia-Pacific and Latin America) present substantial growth opportunities owing to rising disposable incomes, urbanization, and increased health awareness.

  • In China: Growing OTC markets and governmental initiatives toward self-medication bolster calcium carbonate and magnesium hydroxide sales.
  • In India: Increased consumption driven by a large rural population with limited healthcare access, in addition to rising urban middle-class demand.

4. Challenges and Opportunities

4.1 Challenges

  • Regulatory hurdles and safety concerns around long-term use of acid suppressants.
  • Market saturation in OTC segments diminishes pricing power.
  • Competition from innovative drug classes and over-the-counter brands.

4.2 Opportunities

  • Repositioning famotidine for novel indications beyond acid suppression, especially in infectious and inflammatory diseases.
  • Developing combination products that integrate calcium and magnesium for synergistic symptomatic relief.
  • Expanding into emerging markets with targeted marketing and affordable formulations.
  • Enhancing consumer engagement through digital health platforms and personalized medicine approaches.

5. Key Takeaways

  • Famotidine faces a transitional phase, with potential for renewed growth via repositioning and research-driven indications, despite current market decline.
  • Calcium carbonate remains a stable, high-volume OTC product with incremental growth driven by demographic shifts and product innovation.
  • Magnesium hydroxide maintains steady demand within the laxative market, with modest growth prospects fueled by aging populations and natural remedy trends.
  • Market opportunities lie in formulation innovation, combination therapies, and emerging markets, while regulatory developments necessitate vigilant compliance strategies.
  • Stakeholders should monitor scientific developments, regulatory landscapes, and demographic shifts to capitalize on evolving market dynamics.

FAQs

Q1: How has the COVID-19 pandemic influenced the market prospects for famotidine?
A1: The pandemic increased research into famotidine’s potential antiviral properties, leading to renewed scientific interest. While clinical evidence remains inconclusive, some studies suggest possible anti-inflammatory benefits, prompting further investigation. However, direct commercial impact is limited pending definitive clinical validation.

Q2: What factors contribute to the stability of calcium carbonate’s market?
A2: Its OTC availability, low cost, dual role as an antacid and dietary supplement, and widespread consumer familiarity ensure consistent demand across diverse demographics, supporting steady market performance.

Q3: Are there significant regulatory concerns impacting magnesium hydroxide formulations?
A3: Magnesium hydroxide generally faces minimal regulatory barriers; however, safety considerations such as renal impairment risks necessitate appropriate labeling and monitoring, especially in vulnerable populations.

Q4: What emerging markets offer the highest growth potential for these drugs?
A4: Countries in Asia-Pacific, including China and India, exhibit rapid urbanization, increasing health awareness, and expanding OTC markets, making them prime growth regions for calcium carbonate and magnesium hydroxide products.

Q5: How might future technological advances influence the market for these drugs?
A5: Innovations in delivery systems, combination formulations, and personalized medicine could improve efficacy, adherence, and patient outcomes, thereby expanding market share and profitability for manufacturers.


References

[1] IQVIA, "Global Pharmaceutical Market Data," 2022.
[2] Grand View Research, "Calcium Supplements Market Size, Share & Trends," 2022.
[3] MarketsandMarkets, "Laxatives Market by Product Type," 2022.
[4] EvaluatePharma, "COVID-19 Impact on the Gastrointestinal Drugs Market," 2022.

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