OMEPRAZOLE; SODIUM BICARBONATE - Generic Drug Details

What are the generic drug sources for omeprazole; sodium bicarbonate and what is the scope of patent protection?

Omeprazole; sodium bicarbonate is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma Intl, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in twenty NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Omeprazole; sodium bicarbonate has five patent family members in five countries.

Twenty-six suppliers are listed for this compound.

Summary for OMEPRAZOLE; SODIUM BICARBONATE

International Patents:	5
US Patents:	8
Tradenames:	4
Applicants:	14
NDAs:	20
Finished Product Suppliers / Packagers:	26
Clinical Trials:	13
DailyMed Link:	OMEPRAZOLE; SODIUM BICARBONATE at DailyMed

Recent Clinical Trials for OMEPRAZOLE; SODIUM BICARBONATE

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

Sponsor	Phase
Misr University for Science and Technology	PHASE2
Food and Drug Administration (FDA)	Phase 1
BioPharma Services, Inc	Phase 1

See all OMEPRAZOLE; SODIUM BICARBONATE clinical trials

Pharmacology for OMEPRAZOLE; SODIUM BICARBONATE

Drug Class	Proton Pump Inhibitor Osmotic Laxative
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE; SODIUM BICARBONATE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for OMEPRAZOLE; SODIUM BICARBONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID OTC	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg	022281	1	2010-04-20
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	20mg/1680mg per packet	021636	1	2007-11-13
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	40 mg/1680 mg per packet	021636	1	2007-08-24
ZEGERID	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg and 40 mg/1100 mg	021849	1	2007-04-30

US Patents and Regulatory Information for 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
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-001	Feb 27, 2006		DISCN	Yes	No
Strides Pharma Intl	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	079182-001	Apr 19, 2013	AB	RX	No	No
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	11,633,478		Y
Zydus	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203345-001	Mar 16, 2018		OTC	No	No
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	12,440,566		Y
Ajanta Pharma Ltd	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	204228-001	Jul 15, 2016	AB	RX	No	No

Expired US Patents for OMEPRAZOLE; SODIUM BICARBONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	RE45198
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,780,882
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	6,699,885
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	6,489,346
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,645,988
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	7,399,772

International Patents for OMEPRAZOLE; SODIUM BICARBONATE

Country	Patent Number	Title	Estimated Expiration
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
World Intellectual Property Organization (WIPO)	2021011669
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)
European Patent Office	3999066	COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)

Supplementary Protection Certificates for OMEPRAZOLE; SODIUM BICARBONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Market Dynamics and Financial Trajectory for Omeprazole and Sodium Bicarbonate

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for gastroenterological treatments features two prominent agents: omeprazole and sodium bicarbonate. Both drugs serve distinct yet occasionally overlapping roles—omeprazole as a proton pump inhibitor (PPI) primarily for acid suppression, and sodium bicarbonate as an alkalizing agent used in indigestion and metabolic acidosis correction. Their market dynamics and financial trajectories are shaped by evolving therapeutic standards, regulatory environments, manufacturing innovations, and global health trends.

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Market Overview

Omeprazole Market Landscape

Introduced in the late 1980s, omeprazole stands as one of the first PPIs, revolutionizing acid-related disorder management. It holds a dominant market share globally, driven by extensive indications covering gastroesophageal reflux disease (GERD), peptic ulcers, Zollinger-Ellison syndrome, and eradication protocols for Helicobacter pylori infections. As of 2022, the global proton pump inhibitor market was valued at approximately USD 14.8 billion, with omeprazole accounting for a significant proportion of this valuation due to its first-mover advantage and broad availability [1].

Market penetration is sustained by the drug’s proven efficacy, safety profile, and cost-effectiveness, especially in generic form. The expansion of prescription use into over-the-counter (OTC) formulations further boosts its availability and sales volume, particularly in North America and Europe.

Sodium Bicarbonate Market Landscape

Sodium bicarbonate operates within a niche segment aimed at indigestion relief, metabolic acidosis amelioration, and certain diagnostic procedures. The global antacid market, which includes sodium bicarbonate, was valued at around USD 2.2 billion in 2022 with a moderate growth rate projected over the coming years, buoyed by increasing GERD prevalence and aging populations globally [2].

While historically a household staple, commercial and institutional demand, especially in hospitals for metabolic management, sustains its market relevance. Sodium bicarbonate’s OTC availability and low manufacturing cost promote steady, if modest, revenue streams.

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Drivers of Market Growth

1. Increasing Prevalence of Acid-Related Disorders: Rising incidences of GERD, peptic ulcers, and lifestyle-related gastrointestinal impairments underpin demand for both drugs.

2. Aging Global Population: Older populations, especially in North America, Europe, and Asia-Pacific, experience higher gastrointestinal disorder prevalence, fueling sustained needs.

3. Brand and Patent Strategies: Loss of patent exclusivity for original omeprazole formulations has led to widespread generic competition, boosting accessibility and volume sales.

4. Over-the-Counter (OTC) Availability: Transition of omeprazole and sodium bicarbonate to OTC status in several markets has broadened consumer access, elevating sales.

5. Advances in Formulation Technologies: Innovations in drug delivery systems enhance efficacy, increase patient adherence, and stimulate demand.

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Market Challenges

1. Regulatory Pressures and Patent Expirations: Patent cliffs for key omeprazole formulations in recent years have resulted in increased generic competition, constraining profit margins.

2. Emergence of Novel Therapies: The advent of newer acid-suppressing agents, including potassium-competitive acid blockers (P-CABs), threaten market share.

3. Safety and Side Effect Concerns: Long-term PPI use has come under scrutiny due to potential associations with kidney disease, osteoporosis, and infections, prompting clinical guidelines to favor conservative prescribing.

4. Supply Chain Disruptions: Post-pandemic global supply chain disruptions affect manufacturing costs and product availability, impacting market stability.

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Financial Trajectory Analysis

Omeprazole

The outlook for omeprazole’s financial performance hinges on several factors:

• Patent Expirations and Generic Competition: Since patent expiry for original formulations in key markets (e.g., 2010s in the US and Europe), sales volume shifted predominantly to generics, which have driven total revenues down but increased accessibility.

• Market Penetration in Emerging Markets: Rising healthcare infrastructure and growing middle-class populations in Asia-Pacific provide fertile ground for continued growth, especially through local manufacturing collaborations.

• OTC Sales Expansion: Regulatory approvals for OTC use in various jurisdictions have led to increased sales volume, although at lower profit margins.

• Patent and Formulation Developments: Companies investing in novel delivery methods or combination products aim to regain some proprietary advantage and premium pricing.

Between 2018 and 2022, global sales for omeprazole experienced a plateau, hovering around USD 7-8 billion annually, impacted by patent expiries and market saturation [1].

Sodium Bicarbonate

• Steady but Limited Growth: While not a blockbuster, sodium bicarbonate enjoys stable demand, particularly in hospital and institutional settings. Its low-cost production and OTC availability constrain pricing power but assure consistent revenues.

• Emerging Applications: Increasing use in diagnostic procedures and metabolic acidosis correction sustains incremental growth, with a projected CAGR of approximately 3% through 2027.

• Regulatory and Safety Dynamics: Concerns over overuse and potential side effects lead to cautious prescribing, but the fundamental utility of sodium bicarbonate preserves its essential market status.

Financial Outlook Summary

The financial trajectory demonstrates moderate growth prospects for sodium bicarbonate, underpinned by steady demand, whereas omeprazole’s revenues will likely reflect a declining trend in branded sales but grow cumulatively through generics and emerging markets.

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Regulatory and Competitive Factors

Regulatory bodies like the FDA and EMA continuously review safety profiles, affecting drug labeling, use restrictions, and market access. For omeprazole, challenges include regulatory scrutiny over long-term PPI effects. Innovations such as fixed-dose combinations (e.g., omeprazole with antacids) and sustained-release formulations serve as competitive differentiation.

For sodium bicarbonate, regulatory guidance centers on proper labeling, especially regarding overuse and contraindications. Market entrants must navigate compliance efficiently to maintain competitiveness.

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Impact of Technological Innovations

Emerging delivery technologies, including nanoparticle formulations, aim to improve bioavailability and reduce side effects. Personalized medicine and pharmacogenomics may refine patient-specific therapy, influencing future commercialization strategies.

Additionally, biosimilar development and manufacturing efficiencies will play vital roles in pricing and access landscapes.

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Global Market Trends

Geographically, North America and Europe represent mature markets, characterized by high penetration and intense competition. In contrast, Asia-Pacific and Latin America exhibit significant growth potential driven by expanding healthcare infrastructure and increasing disease burdens.

Segmentation reflects a transition toward combination therapies and OTC availability, broadening consumer base and enhancing revenue streams.

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Key Takeaways

• Market Growth: Omeprazole remains a leading acid-suppression agent with sustained demand driven by global GERD prevalence, despite patent expirations and generic competition. Sodium bicarbonate’s market is characterized by stability and incremental growth, primarily in institutional settings.

• Financial Trajectories: Generic proliferation suppresses peak revenues for omeprazole, but expanded geographic reach and OTC sales offset some declines. Sodium bicarbonate’s low-cost, ubiquitous use ensures steady revenues with limited upside.

• Strategic Focus: Innovation in formulations, combination therapies, and personalized medicine will shape future competitiveness, particularly for omeprazole. Regulatory vigilance and safety profiles remain critical considerations.

• Global Opportunities: Emerging markets present significant growth opportunities, driven by rising disease prevalence and expanding healthcare infrastructure.

• Market Risks: Regulatory changes, safety concerns, and competitive innovation threaten market share. Maintaining differentiation and adhering to safety standards are paramount.

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FAQs

1. How has patent expiration affected omeprazole’s market dynamics?
   Patent expirations introduced a flood of generic competitors, leading to price erosion and flattened revenues in branded sales. However, increased volume sales through OTC channels and expansion into emerging markets have helped stabilize total revenues.

2. What emerging therapies could threaten the traditional omeprazole market?
   Potassium-competitive acid blockers (P-CABs) such as vonoprazan offer more potent and longer-lasting acid suppression, positioning as potential successors and competitors in the PPI class.

3. Are there safety concerns associated with long-term omeprazole use?
   Yes. Long-term use has been linked to risks such as kidney disease, fractures, and infections. These concerns influence prescribing guidelines and patient monitoring strategies.

4. What role does sodium bicarbonate play in laboratory diagnostics?
   It is used in procedures like urinary pH adjustment and as a buffering agent, maintaining its importance in hospital settings despite limited commercial growth.

5. How can pharmaceutical companies capitalize on growth opportunities for these drugs?
   Innovations in formulation, expanding access through OTC markets, targeting developing regions, and developing combination therapies are key strategies for growth.

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References

[1] MarketWatch. "Proton Pump Inhibitors (PPIs) Market Size, Share & Trends." 2022.
[2] Grand View Research. "Antacid Market Size, Share & Trends Analysis." 2022.