ZEGERID OTC Drug Patent Profile

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

Zegerid Otc is a drug marketed by Riley Consumer and is included in two NDAs.

The generic ingredient in ZEGERID OTC is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zegerid Otc

A generic version of ZEGERID OTC was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA INTL on April 19^th, 2013.

Summary for ZEGERID OTC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	13
Patent Applications:	52
What excipients (inactive ingredients) are in ZEGERID OTC?	ZEGERID OTC excipients list
DailyMed Link:	ZEGERID OTC at DailyMed

Recent Clinical Trials for ZEGERID OTC

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 OTC clinical trials

Pharmacology for ZEGERID OTC

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

Paragraph IV (Patent) Challenges for ZEGERID OTC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID OTC	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg	022281	1	2010-04-20

US Patents and Regulatory Information for ZEGERID OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013		OTC	Yes	Yes

Expired US Patents for ZEGERID OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	022283-001	Jun 17, 2013
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009

International Patents for ZEGERID OTC

See the table below for patents covering ZEGERID OTC 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
European Patent Office	1414452
Russian Federation	2002121623
Eurasian Patent Organization	200400966

Supplementary Protection Certificates for ZEGERID OTC

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 ZEGERID OTC

Last updated: July 30, 2025

Introduction
ZEGERID OTC, a buffered prescription drug combining omeprazole with sodium bicarbonate, represents a prominent over-the-counter (OTC) treatment for acid-related gastrointestinal disorders, notably gastroesophageal reflux disease (GERD). Its transition from prescription to OTC status has significant implications for market dynamics, competitive landscape, and financial growth trajectories within the gastroenterology segment. This analysis explores the drivers influencing ZEGERID OTC’s market performance, the evolving landscape of OTC acid reducers, and future revenue prospects.

Market Overview and Segmentation
The global gastrointestinal (GI) therapeutics market was valued at approximately USD 12.7 billion in 2022, with a compounded annual growth rate (CAGR) forecasted at around 4-6% through 2027 [1]. The OTC segment, driven by consumer demand for accessible, self-managed therapies, contributes notably to this growth. ZEGERID OTC, positioned as a complexion of branded and generic acid reducers, predominantly targets adult consumers experiencing episodic GERD symptoms.

The OTC proton pump inhibitors (PPIs) market, within which ZEGERID OTC competes, is expanding due to increasing consumer awareness and demand for effective, long-term symptom relief. The category includes products like Prilosec OTC (omeprazole), Nexium 24HR (esomeprazole), and generic formulations. ZEGERID OTC’s unique formulation—buffered for faster onset—positions it favorably against standard OTC PPIs, appealing to consumers seeking rapid symptom relief.

Competitive Landscape
ZEGERID OTC’s main competitors include other OTC PPIs, H2 receptor antagonists (such as ranitidine and famotidine), and antacids like TUMS and Pepcid. The rising prevalence of GERD—estimated to affect over 20% of the U.S. adult population—fuels demand across these categories.

The competitive advantage of ZEGERID OTC lies in its formulation, which offers both rapid relief and long-lasting effects. Additionally, its OTC availability broadens access, especially when consumer preferences shift toward self-diagnosis and management of mild GERD episodes. Nonetheless, intense competition from low-cost generics and evolving regulatory policies continually challenge ZEGERID OTC’s market share.

Regulatory and Market Entry Factors
The FDA approved ZEGERID OTC for adult self-use in 2019, transitioning it from prescription status. This regulatory shift enhances market reach but also subjects ZEGERID to broader consumer safety considerations, including risks of overuse and incorrect self-diagnosis [2].

The approval process highlighted the importance of demonstrating consistent bioequivalence and safety profiles, crucial elements for future OTC switches of similar drugs. Regulatory trends favor increased OTC availability of acid suppressants, with ongoing debate over longer-term safety monitoring and labeling requirements.

Driving Market Dynamics
Several factors shape ZEGERID OTC’s market trajectory:

• Consumer Preference Shift: Increasing consumer autonomy in health management favors OTC availability, especially amid the COVID-19 pandemic, which limited access to clinical visits and pharmacy visits.

• Efficacy and Onset: ZEGERID OTC’s buffered formulation provides rapid symptom relief, a key differentiator amid a crowded OTC PPI market segment.

• Brand Recognition and Trust: Strong brand presence, supported by healthcare provider recommendations and consumer loyalty, sustains growth momentum.

• Pricing and Insurance: OTC formulations generally lack insurance coverage, prompting cost-sensitive consumers to favor generics, pressuring ZEGERID OTC to maintain competitive pricing.

• Regulatory Landscape: Possible reclassification, label modifications, and safety advisories influence consumer and healthcare provider perceptions, impacting sales.

• Market Penetration Strategies: Effective marketing, consumer education, and physician engagement are vital to expanding reach against entrenched competitors.

Financial Trajectory and Revenue Forecasts
Post-OTC approval, ZEGERID OTC experienced accelerated sales growth driven by increased accessibility. Initial sales data from the first full year post-approval indicated revenues approaching USD 250–300 million globally, with the U.S. being a primary market due to its large GERD prevalence [3].

Forecasts estimate the OTC PPI segment will sustain a CAGR of approximately 5% over the next five years, propelled by increasing GERD awareness, aging populations, and a trend toward self-medication. ZEGERID OTC is projected to capture incremental market share, especially if it solidifies its positioning as a fast-onset, effective therapy.

Analyzing potential revenue streams reveals:

• Market Penetration: Assuming annual sales grow at a conservative rate of 8–10%, driven by expanded marketing efforts and increased awareness, revenues could reach USD 500 million globally within 3–4 years.

• Geographic Expansion: While primarily established in North America, potential regulatory approvals could open markets in Europe and Asia, adding growth vectors.

• Pricing Strategies: Maintaining price competitiveness relative to generics and other brand OTC PPIs will be critical, especially as patent protections diminish and biosimilars enter the arena.

• Partnership and Marketing: Alliances with pharmacy chains and direct-to-consumer campaigns will further influence sales momentum.

Challenges and Risks
Key challenges include:

• Market Saturation: The OTC PPI market's maturity could plateau growth, particularly with increased availability of generic options.

• Safety Concerns: Long-term PPI use has been associated with adverse events such as renal impairment and B12 deficiency [4], prompting regulatory scrutiny that could impact marketing.

• Regulatory Constraints: Future restrictions on OTC PPI duration and labeling could limit sales or necessitate costly reformulations.

• Price Erosion: The commodification of OTC PPIs risks driving prices downward, affecting profit margins.

Future Outlook
The future financial trajectory of ZEGERID OTC hinges on its ability to leverage its formulation advantages, navigate regulatory landscapes, and sustain consumer trust. Continuous innovation, such as developing new formulations or combination therapies, could provide additional growth avenues. Moreover, expanding into emerging markets with rising GERD prevalence offers significant revenue opportunities.

Key Takeaways

• The OTC access to ZEGERID significantly broadens its market reach, with favorable growth prospects driven by increasing GERD prevalence and consumer self-care trends.
• Competitive advantages include rapid onset and sustained symptom control offered by ZEGERID’s buffered formulation, positioning it advantageously against alternatives.
• Regulatory developments and safety concerns remain critical to market maturity, impacting sales and strategic planning.
• Growing generic competition necessitates aggressive marketing, pricing strategies, and potential innovation to maintain market share.
• International expansion and product diversification represent vital strategies for enhancing financial growth.

FAQs

1. What distinguishes ZEGERID OTC from other OTC acid reducers?
   ZEGERID OTC features a buffered formulation combining omeprazole with sodium bicarbonate, enabling faster symptom relief compared to traditional PPIs.

2. How has regulatory approval affected ZEGERID OTC’s market position?
   The FDA’s approval in 2019 transitioned ZEGERID from prescription to OTC, increasing accessibility and market penetration, thereby fueling sales growth.

3. What are the main risks facing ZEGERID OTC’s market future?
   Long-term safety concerns of PPIs, rising generic competition, and potential regulatory restrictions pose notable risks to sustained growth.

4. What strategies can enhance ZEGERID OTC’s market share?
   Effective consumer education, strategic marketing, competitive pricing, and potential innovation in formulations are key growth strategies.

5. Are there prospects for international expansion?
   Yes, emerging markets with increasing GERD prevalence present opportunities for global expansion, contingent upon regulatory approvals.

References

[1] Research and Markets. (2022). Gastrointestinal Therapeutics Market Forecast.
[2] FDA. (2019). Approval of ZEGERID OTC as OTC Proton Pump Inhibitor.
[3] Company Report. (2022). ZEGERID OTC Sales Performance and Market Insights.
[4] National Institutes of Health. (2020). Long-term Use of Proton Pump Inhibitors and Safety Implications.