MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE Drug Patent Profile

Which patents cover Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate, and what generic alternatives are available?

Magnesium Hydroxide And Omeprazole And Sodium Bicarbonate is a drug marketed by Santarus and is included in one NDA.

The generic ingredient in MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and forty-six drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE at DailyMed

Recent Clinical Trials for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 4
Bausch Health Americas, Inc.	Phase 4
Yvonne Romero	Phase 4

See all MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE clinical trials

US Patents and Regulatory Information for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND 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	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009		DISCN	No	No
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009		DISCN	No	No

Expired US Patents for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	6,699,885
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	6,489,346
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	7,399,772

International Patents for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

See the table below for patents covering MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2002121623
Eurasian Patent Organization	200400966
Japan	2012136531	NEW SUBSTITUTED BENZIMIDAZOLE DOSAGE FORM AND METHOD FOR USING THE SAME

Supplementary Protection Certificates for MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	C300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105

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

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for antacid and gastric medication formulations—specifically magnesium hydroxide, omeprazole, and sodium bicarbonate—continues to evolve amidst shifting consumer demands, technological advancements, and regulatory pressures. These agents, pivotal in managing gastrointestinal disorders, collectively represent a significant segment with increasing global adoption. Understanding their market dynamics and financial trajectory aids stakeholders in strategic planning, investment decisions, and innovation pathways.

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Market Overview

Pharmacological Roles and Market Drivers

• Magnesium Hydroxide: An antacid used to neutralize stomach acid, alleviate indigestion, and manage hyperphosphatemia, with a longstanding presence in OTC and prescription markets.
• Omeprazole: A proton pump inhibitor (PPI) extensively prescribed for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.
• Sodium Bicarbonate: Used as an antacid, systemic alkalizer, and in medical procedures to buffer acids.

The increasing prevalence of acid-related disorders—driven by lifestyle, dietary habits, and aging populations—continues to propel demand. Additionally, rising awareness about gastrointestinal health attributes to sustained sales growth.

Market Size and Growth Trends

The global market for gastrointestinal drugs, including these agents, was valued at approximately $12 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of 4-6% over the next five years [1]. The segment comprising magnesium hydroxide, omeprazole, and sodium bicarbonate is expected to sustain robust growth, driven by aging demographics, rising healthcare expenditure, and expanding OTC accessibility.

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Market Dynamics

Supply Chain and Manufacturing

Manufacturing relies heavily on raw material availability—particularly magnesium salts, sodium compounds, and active pharmaceutical ingredients (APIs). Regulatory standards for quality and safety have intensified, prompting investments in quality control and supply chain resilience. The consolidation of manufacturers—large pharma and OTC players—further influences pricing and distribution channels.

Regulatory Environment

Regulatory agencies, including the FDA and EMA, enforce strict quality, safety, and efficacy standards. Patent expirations for key drugs, notably omeprazole (with numerous generic versions), have intensified market competition, prompting innovation in formulations and delivery systems.

Competitive Landscape

• Generic proliferation: Omeprazole's patent has expired, leading to widespread generic competition, which exerts downward pressure on prices.
• OTC expansion: Governments and health authorities favor OTC distribution for cost-effective management, especially for magnesium hydroxide and sodium bicarbonate.
• Innovation: Extended-release formulations, combination therapies, and novel PPI molecules (e.g., esomeprazole) are emerging to capture market share.

Consumer Trends

A shift toward self-medication, online pharmacy sales, and awareness campaigns influences product accessibility and market penetration. However, safety concerns—like potential adverse effects of long-term PPI use—urge manufacturers to adopt responsible marketing and clear labeling.

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Financial Trajectory

Revenue Streams

• Branded vs. Generic: As patents for original formulations expire, generic versions dominate revenue, often leading to reduced profit margins but increased volume.
• OTC vs. Prescription: OTC formulations generate steady revenue streams owing to broad consumer access. Prescription sales remain significant for severe cases and specialized indications.
• Regional Disparities: North America leads the market, accounting for approximately 40% of revenues. Asia-Pacific exhibits the fastest growth, driven by large populations and increasing healthcare access.

Profit Margins and Cost Factors

Margins for generic products are typically lower but compensated by high volume. Cost factors affecting profitability include raw material fluctuations, manufacturing compliance costs, and marketing expenditures.

Forecasting the Financial Path

Analysts project the combined market for these agents to grow from $12 billion in 2022 to approximately $17-20 billion by 2030. This growth trajectory is driven by:

• Continued prevalence of gastrointestinal disorders.
• Innovation leading to improved formulations and delivery mechanisms.
• Expansion of OTC markets.
• Increasing healthcare expenditure globally.

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Emerging Trends and Future Outlook

Technological Innovation

Development of targeted delivery systems, such as nanoparticles for omeprazole, and combination agents that address multiple GI conditions are on the rise. Biobetters and biosimilars may redefine patient options.

Personalized Medicine

Genetic profiling for PPI responsiveness could optimize therapy, impacting market dynamics through tailored treatments.

Regulatory and Policy Concerns

Growing evidence of PPI-linked risks (e.g., nutrient malabsorption, infections) could induce stricter regulations or new treatment guidelines, potentially impacting sales growth.

Market Challenges

• Patent expirations and generic competition.
• Safety concerns impacting long-term use.
• Market access restrictions in emerging regions.

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Conclusion: Strategic Implications

The outlook for magnesium hydroxide, omeprazole, and sodium bicarbonate remains favorable, with sustained growth driven by demographic, technological, and market expansion factors. Companies investing in innovative formulations, global distribution channels, and compliance readiness will be better positioned to capitalize on emerging opportunities.

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Key Takeaways

• The combined GI drug market surpasses $12 billion, with consistent growth anticipated at 4-6% CAGR.
• Patent expirations foster a competitive landscape favoring generics, but innovation in drug delivery and formulations adds value.
• Rising prevalence of GI disorders, especially in aging populations, ensures ongoing demand.
• Expansion of OTC availability and technological advancements will catalyze revenue growth.
• Regulatory scrutiny and safety concerns necessitate vigilant compliance and responsible marketing strategies.

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FAQs

1. What factors primarily influence the market growth for magnesium hydroxide, omeprazole, and sodium bicarbonate?
   Growth is driven by increasing prevalence of acid-related gastrointestinal conditions, demographic shifts (aging populations), OTC accessibility, and ongoing technological innovations.

2. How does patent expiry impact the financial performance of omeprazole-based products?
   Patent expiry leads to the proliferation of generic versions, reducing prices and profit margins for brand-name formulations but increasing overall sales volume.

3. What emerging trends could disrupt the current market trajectory?
   Development of targeted delivery systems, personalized medicine approaches, and regulatory changes due to safety concerns could redefine competitive dynamics.

4. Which regions exhibit the highest growth potential for these drugs?
   The Asia-Pacific region promises rapid expansion due to large populations, rising healthcare infrastructure, and increasing healthcare awareness.

5. What are the key regulatory challenges faced by manufacturers in this segment?
   Ensuring compliance with safety standards, managing adverse effect disclosures, and navigating evolving guidelines for OTC and prescription medicines are primary concerns.

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References

[1] Global Market Insights. "Gastrointestinal Disease Therapeutics Market Size," 2022.