ZEGERID Drug Patent Profile

Which patents cover Zegerid, and when can generic versions of Zegerid launch?

Zegerid is a drug marketed by Salix, Santarus, and Riley Consumer. and is included in five NDAs.

The generic ingredient in ZEGERID 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 ZEGERID

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	13
Drug Prices:	Drug price information for ZEGERID
What excipients (inactive ingredients) are in ZEGERID?	ZEGERID excipients list
DailyMed Link:	ZEGERID at DailyMed

See drug prices for ZEGERID

Recent Clinical Trials for ZEGERID

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

Sponsor	Phase
Syndax Pharmaceuticals	Phase 1
Population Health Research Institute	Phase 3
Norgine	Phase 3

See all ZEGERID clinical trials

Pharmacology for ZEGERID

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Paragraph IV (Patent) Challenges for ZEGERID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 ZEGERID

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
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004		DISCN	Yes	No
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes

Expired US Patents for ZEGERID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004

International Patents for ZEGERID

See the table below for patents covering ZEGERID around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	331542
Spain	2275650
Russian Federation	2279276	НОВЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ЗАМЕЩЕННЫХ БЕНЗИМИДАЗОЛОВ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (NEW MEDICINAL FORMULATIONS OF SUBSTITUTED BENZIMIDAZOLES AND METHOD FOR THEIR USING)
Australia	2005229686

Supplementary Protection Certificates for ZEGERID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
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	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313

Market Dynamics and Financial Trajectory for ZEGERID

Last updated: July 27, 2025

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Introduction

ZEGERID, a proton pump inhibitor (PPI) formulated as a capsule combining omeprazole and sodium bicarbonate, has maintained a significant presence in the gastric acid suppression market since its FDA approval in 2003. Its unique formulation, offering rapid onset and sustained acid suppression, positions it within the competitive landscape of OTC and prescription therapies targeting gastroesophageal reflux disease (GERD), peptic ulcers, and related acid-related disorders. This analysis explores the evolving market conditions, revenue streams, competitive dynamics, regulatory influences, and future prospects shaping ZEGERID’s financial trajectory.

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Market Overview and Demand Drivers

The global gastroesophageal reflux disease (GERD) therapeutics market was valued at approximately USD 8.3 billion in 2022 and is projected to grow at a CAGR of around 4–5% through 2030, driven by increasing prevalence, aging populations, and lifestyle factors (Source: Grand View Research). ZEGERID, leveraging its OTC and prescription formulations, targets key segments within this expanding market.

Key demand drivers include:

• Rising GERD prevalence: An estimated 20–30% of Western populations experience GERD symptoms regularly. The condition’s chronic nature encourages long-term medication use.
• Shift toward over-the-counter (OTC) options: Regulatory approvals enabling OTC availability bolster sales volume and accessibility, particularly in developed markets.
• Growing awareness of acid-related disorders: Patient education campaigns and doctor-patient dialogues increase diagnosis and medication adherence.
• Reimbursement and healthcare policies: Reimbursement models favor cost-effective OTC options, reducing healthcare system burdens.

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Market Dynamics Influencing ZEGERID

Competitive Landscape

ZEGERID operates amidst a crowded sector, competing primarily with other PPIs such as omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix), and newer agents like vonoprazan. Its unique formulation combining omeprazole with sodium bicarbonate offers an advantage by reducing the time to symptom relief and possibly enhancing bioavailability. However, patent expirations and generic proliferation pose risks.

Patent and Exclusivity Considerations

Original ZEGERID formulations held patents protecting its unique delivery system; however, these patents have now largely expired. Generic versions of omeprazole dominate OTC sales, significantly reducing ZEGERID’s market share in some segments. The loss of regulatory exclusivity tempers revenue growth but opens opportunities for strategic repositioning.

Regulatory and Reimbursement Environment

While prescription ZEGERID benefits from physician oversight, OTC sales are regulated by agencies like the FDA, with reclassification potential influencing market access. Reimbursement policies favor less costly OTC options, but insurers typically do not cover OTC drugs, limiting direct reimbursement revenue.

Distribution Channels and Market Penetration

Distribution through pharmacies, healthcare providers, and online platforms impacted sales. E-commerce channels have gained prominence, especially during the COVID-19 pandemic, expanding accessibility. Strategic partnerships with pharmacy chains and online retailers contribute to growth.

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Financial Trajectory and Revenue Outlook

Historical Performance

Historically, ZEGERID generated peak annual revenues exceeding USD 300 million before patent expiry and market saturation shifted sales toward generics. Post-2010, revenues declined due to increased generic competition, with a substantial dip following patent losses around 2013–2015. (Source: EvaluatePharma)

Current Revenue Streams

Currently, ZEGERID’s revenues are primarily derived from:

• Prescription formulations: Limited to specific indications, with sales influenced by physician prescribing habits.
• OTC formulations: Dominant segment, with sustained growth owing to OTC market expansion.
• Strategic licensing and co-marketing agreements: Enhancing distribution reach.

Future Revenue Projections

The outlook hinges on several factors:

• Reformulation and innovation: Development of new formulations or combination therapies can rejuvenate interest.
• Regulatory reclassification: Potential switch from prescription to OTC status for specific indications could revitalize sales.
• Market penetration: Expanding into emerging markets with high GERD prevalence could boost revenues.
• Market share shifts: Competitor launches and generic entry pose ongoing threats.

Forecast models suggest that, absent significant innovation, ZEGERID’s revenues are expected to stabilize or decline modestly over the next 3–5 years. However, targeted strategic initiatives could foster slight growth in select segments.

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Key Market Trends Impacting ZEGERID's Financial Outlook

• Growing OTC Acidity Therapy Market: As consumers seek quick, accessible solutions, OTC PPIs like ZEGERID benefit from increased self-medication trends.
• Generic Price Competition: Volume erosion due to generics pressures margins.
• Innovation and Biosimilar Entry: Continued development of novel acid suppression agents, such as potassium-competitive acid blockers (P-CABs), challenge existing PPIs.
• Digital Health Integration: Telemedicine and online pharmacies facilitate broader, immediate access, influencing pharmacy revenues.

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Strategic Positioning and Growth Opportunities

To enhance financial performance, ZEGERID’s stakeholders should consider:

• Product differentiation: Emphasize rapid relief and unique formulation benefits.
• Market expansion: Target emerging economies with rising GERD incidence.
• Extended indications and formulations: Explore new therapeutic claims, including maintenance therapy or combination products.
• Re-optimization of marketing strategies: Leverage digital platforms and direct-to-consumer marketing.

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Risks and Challenges

• Patent expiries and generic competition threaten revenue streams.
• Regulatory hurdles and delays in reclassification or approval of new formulations.
• Market saturation in mature regions diminishes growth potential.
• Evolving scientific landscape favoring new classes of acid suppressants over traditional PPIs.

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Conclusion

ZEGERID's financial trajectory reflects a typical lifecycle pattern of pioneering drugs facing patent expiration and robust generic competition. While current revenues are sustained by OTC accessibility and niche prescription markets, future growth prospects depend heavily on strategic innovation, market expansion, and regulatory navigation. Its position within a highly competitive, rapidly evolving market underscores the importance of adaptive strategies to maximize value.

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Key Takeaways

• The global GERD market's upward trend offers growth potential, yet ZEGERID’s revenues face pressure from generics.
• Expiration of patents and increased competition necessitate innovation and market differentiation.
• OTC sales remain the primary revenue driver, with online distribution channels expanding reach.
• Future growth hinges on regulatory reclassification, geographic expansion, and product development.
• Strategic responses must address market saturation, competitive threats, and emerging therapies.

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FAQs

Q1: What are the main factors impacting ZEGERID's market share?
A1: Patent expirations, the proliferation of generic omeprazole, and emerging new acid suppression therapies significantly impact ZEGERID’s market share.

Q2: How does the OTC status influence ZEGERID’s revenue potential?
A2: OTC availability broadens consumer access, fueling sales volume. However, it limits pricing power and reimbursement opportunities, constraining revenue growth.

Q3: What are the key competitive advantages of ZEGERID?
A3: Its unique formulation combining omeprazole with sodium bicarbonate offers rapid symptom relief, which can differentiate it from other PPIs.

Q4: Which markets present the greatest growth opportunities for ZEGERID?
A4: Emerging markets with rising GERD prevalence and limited access to prescription medications offer significant growth potential.

Q5: How might future regulatory changes affect ZEGERID’s commercial prospects?
A5: Reclassification to OTC for additional indications could expand sales, while delays or denials could restrict market access and revenue prospects.

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References

[1] Grand View Research. "Gastroesophageal Reflux Disease Market Size & Trends." 2022.
[2] EvaluatePharma. "Global Oncology and Gastrointestinal Therapeutics Revenue Trends." 2021.
[3] FDA. "Guidance on OTC Proton Pump Inhibitors." 2020.