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Last Updated: December 11, 2025

MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - Generic Drug Details


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What are the generic sources for magnesium hydroxide; omeprazole; sodium bicarbonate and what is the scope of freedom to operate?

Magnesium hydroxide; omeprazole; sodium bicarbonate is the generic ingredient in two branded drugs marketed by Santarus and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Clinical Trials: 1
DailyMed Link:MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE at DailyMed
Recent Clinical Trials for MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 4
Bausch Health Americas, Inc.Phase 4
Yvonne RomeroPhase 4

See all MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE clinical trials

US Patents and Regulatory Information for MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-001 Mar 24, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Santarus MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE magnesium hydroxide; omeprazole; sodium bicarbonate TABLET;ORAL 022456-001 Dec 4, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Santarus ZEGERID magnesium hydroxide; omeprazole; sodium bicarbonate TABLET, CHEWABLE;ORAL 021850-002 Mar 24, 2006 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Santarus MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE magnesium hydroxide; omeprazole; sodium bicarbonate TABLET;ORAL 022456-002 Dec 4, 2009 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

Expired US Patents for MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Market Dynamics and Financial Trajectory for Magnesium Hydroxide, Omeprazole, and Sodium Bicarbonate

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape continually evolves amid changing consumer preferences, technological advancements, and regulatory shifts. Critical to this landscape are drugs such as magnesium hydroxide, omeprazole, and sodium bicarbonate—each serving essential roles in gastrointestinal (GI) treatment. This analysis explores the market dynamics and financial trajectories of these pharmaceuticals, emphasizing their current status, growth drivers, challenges, and future outlook.

Market Overview of Magnesium Hydroxide, Omeprazole, and Sodium Bicarbonate

Magnesium Hydroxide

Magnesium hydroxide, commonly known as "milk of magnesia," is an antacid and laxative widely used to neutralize stomach acid and relieve indigestion, hyperacidity, and constipation. The market for magnesium hydroxide remains stable due to its longstanding efficacy, affordability, and minimal side effects. Its primary applications extend from over-the-counter (OTC) supplements to pharmaceutical formulations.

Omeprazole

Omeprazole, a proton pump inhibitor (PPI), revolutionized acid suppression therapy upon its release, addressing conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. As a flagship PPI, omeprazole's market share remains robust amid increasing prevalence of acid-related disorders. Its formulations, both prescription and OTC, contribute significantly to revenues.

Sodium Bicarbonate

Sodium bicarbonate acts as an antacid, buffering stomach acid, and also finds applications in emergency medicine, renal therapy, and industrial uses. Its widespread availability and affordability sustain steady demand, especially in OTC markets. The rise in GERD and indigestion cases globally bolster the sodium bicarbonate market.

Market Dynamics

Drivers

1. Rising Prevalence of Acid-Related Disorders
An escalation in GERD, peptic ulcer disease, and functional dyspepsia globally fuels demand for related medications. Sedentary lifestyles, obesity, and processed diets contribute to the escalating burden of these conditions, intensifying pharmaceutical sales.

2. Aging Population
Globally aging demographics drive increased prescription of acid suppressants and antacids, as the elderly are more prone to GI conditions. The expanding elderly cohort critically sustains demand for magnesium hydroxide, omeprazole, and sodium bicarbonate.

3. OTC Accessibility and Consumer Awareness
OTC availability of magnesium hydroxide and sodium bicarbonate facilitates easy access, translating to consistent sales growth. Consumer awareness campaigns and self-medication trends reinforce this trajectory.

4. Patent Expirations and Generic Competition
The expiration of patents for branded formulations, particularly for omeprazole, has led to an influx of generics. Competition drives prices downward but simultaneously broadens market penetration, offsetting revenue declines with volume increases.

5. Innovative Delivery Technologies
Advancements in sustained-release formulations, combination therapies, and novel delivery mechanisms optimize patient adherence and expand market reach, particularly for omeprazole.

Challenges

1. Safety and Side Effect Profiles
Long-term use of PPIs like omeprazole has been scrutinized for potential adverse effects such as nutrient malabsorption (e.g., magnesium deficiency), dependency, and increased infection risks. Such concerns influence prescribing behaviors and consumer perception.

2. Regulatory Scrutiny and Evolving Guidelines
Regulatory agencies, including the FDA and EMA, continually update safety and efficacy guidelines, affecting market approvals and post-marketing surveillance.

3. Market Saturation and Price Erosion
Generic proliferation results in price erosion, impacting profit margins for manufacturers. Moreover, OTC saturation limits new customer acquisition.

4. Supply Chain Disruptions
Global events like the COVID-19 pandemic highlighted vulnerabilities in raw material supply chains for active pharmaceutical ingredients (APIs), affecting production and pricing.

Opportunities

1. Expansion into Emerging Markets
Rising healthcare infrastructure and increasing health literacy in Asia-Pacific, Latin America, and Africa provide fertile ground for market expansion.

2. Developing Novel Formulations
Technological innovation, including targeted delivery and combination therapies, promises incremental growth and differentiation.

3. Growing Awareness and Preventive Healthcare
Proactive management of GI health through dietary guidance and early intervention bolsters demand for OTC antacids and supplements.

Financial Trajectory and Market Forecasts

Market Size and Growth Projections

Research indicates the global antacid market (encompassing magnesium hydroxide and sodium bicarbonate) is projected to reach approximately USD 6 billion by 2027, growing at a CAGR of 4.5% from 2022 to 2027 [1]. The PPI segment, driven largely by omeprazole, is expected to dominate with a CAGR of 5%, reaching nearly USD 30 billion globally.

Revenue Streams

  • Magnesium Hydroxide: Predominantly OTC sales; global revenues estimated at USD 1.2 billion in 2022, with steady annual growth. Growth is driven by self-medication trends and expanding aging populations.

  • Omeprazole: As a leading PPI, global sales surpass USD 10 billion annually, with increased adoption in developing nations. Patent expiration accelerated the entry of generics, reducing unit price but boosting volume sales.

  • Sodium Bicarbonate: While primarily OTC, its applications in emergency medicine and industrial sectors contribute to revenues of approximately USD 1 billion, with moderate growth.

Regional Market Dynamics

North America: Largest market share, driven by high healthcare expenditure, aging demographics, and OTC accessibility.

Europe: Mature market with high penetration; growth fueled by expanded indications and OTC sales.

Asia-Pacific: Fastest-growing segment, fueled by rising urbanization, increasing disposable incomes, and expanding healthcare infrastructure.

Key Players and Competitive Landscape

Major pharmaceutical companies, including Johnson & Johnson, AstraZeneca, and Teva Pharmaceuticals, dominate the market through a mix of branded and generic formulations. Strategic alliances, mergers, and acquisitions focus on expanding product portfolios and geographic reach.

Regulatory and Patent Considerations

Patent expirations have unlocked generics markets, intensifying competition but lowering prices. Regulatory agencies’ emphasis on pharmacovigilance and safety data influences market approvals and post-market performance. Continuous innovation, including combination therapies and novel formulations, remains key to maintaining competitive advantage.

Future Outlook

The trajectory for magnesium hydroxide, omeprazole, and sodium bicarbonate appears resilient, supported by persistent demand and demographic trends. The integration of digital health tools, personalized medicine, and supply chain efficiencies could further enhance profitability. However, the increasing regulatory scrutiny necessitates vigilance around safety profiles to sustain market acceptance.

Key Takeaways

  • The GI therapeutics market, driven by magnesium hydroxide, omeprazole, and sodium bicarbonate, is poised for steady growth, with a projected CAGR of approximately 4.5% through 2027.
  • Demographic shifts, particularly aging populations, and rising prevalence of acid-related disorders serve as primary growth catalysts.
  • Patent expirations have enhanced market competition, leading to lower prices but higher volumes, especially for omeprazole.
  • Emerging markets represent significant expansion opportunities, leveraging increasing healthcare infrastructure and consumer awareness.
  • Innovation in formulations and delivery mechanisms will be instrumental in differentiating products and sustaining profitability amid regulatory challenges and generic competition.

FAQs

1. How will patent expirations affect the profitability of omeprazole manufacturers?
Patent expirations have introduced numerous generics, leading to pricing pressure and decreased revenue per unit. Nevertheless, increased volume sales and expanding global markets, especially in emerging economies, can offset margins, sustaining overall profitability.

2. Are there safety concerns associated with long-term use of these drugs?
Yes. Long-term PPI use, including omeprazole, has been linked to potential adverse effects such as nutrient deficiencies, kidney disease, and infections. These concerns may influence prescribing patterns and regulatory requirements.

3. What emerging markets offer growth opportunities for these drugs?
Asia-Pacific, Latin America, and Africa present significant opportunities due to rising healthcare infrastructure, improved health literacy, and increased adoption of OTC medications.

4. How might technological innovations impact the market?
Advancements such as sustained-release formulations, combination therapies, and digital adherence tools can improve patient outcomes, differentiate products, and open new revenue streams.

5. What regulatory trends should market participants monitor?
Regulatory agencies' evolving safety standards, post-marketing surveillance requirements, and approval pathways for generics and biosimilars significantly influence market dynamics.


Sources
[1] Market Research Future, “Antacid Market Forecast to 2027,” 2022.

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