PYLORI-CHEK BREATH TEST Drug Patent Profile

When do Pylori-chek Breath Test patents expire, and when can generic versions of Pylori-chek Breath Test launch?

Pylori-chek Breath Test is a drug marketed by Dxs Devices and is included in one NDA.

The generic ingredient in PYLORI-CHEK BREATH TEST is urea c-13. There are thirty-three drug master file entries for this compound. Additional details are available on the urea c-13 profile page.

Summary for PYLORI-CHEK BREATH TEST

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PYLORI-CHEK BREATH TEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dxs Devices	PYLORI-CHEK BREATH TEST	urea c-13	FOR SOLUTION;ORAL	020900-001	Feb 4, 1999		DISCN	No	No

PYLORI-CHEK BREATH TEST: INVESTMENT LANDSCAPE ANALYSIS

Last updated: February 19, 2026

PYLORI-CHEK BREATH TEST is a diagnostic device for detecting Helicobacter pylori (H. pylori) infection. Investment in this area centers on the prevalence of H. pylori-related gastrointestinal disorders, the test's accuracy and convenience compared to alternatives, and the regulatory and competitive environment.

WHAT IS THE MARKET NEED FOR H. PYLORI DIAGNOSTICS?

H. pylori is a bacterium linked to peptic ulcers, gastritis, and gastric cancer. Global prevalence varies, with higher rates in developing nations.

• Prevalence: Estimated global prevalence of H. pylori is between 30% and 80% of the population, depending on the region and demographic [1].
• Disease Burden: H. pylori infection is responsible for approximately 89% of peptic ulcer disease cases and is a significant risk factor for gastric adenocarcinoma and MALT lymphoma [2].
• Screening and Eradication: Diagnosis is crucial for initiating eradication therapy, which can prevent severe complications and reduce cancer risk.

WHAT IS PYLORI-CHEK BREATH TEST AND HOW DOES IT COMPARE?

PYLORI-CHEK BREATH TEST is a non-invasive urea breath test. It measures the amount of carbon-13 labeled carbon dioxide (¹³CO₂) in exhaled breath after a patient ingests a urea solution containing ¹³C.

Diagnostic Method	Principle	Invasiveness	Typical Accuracy (Sensitivity/Specificity)	Cost (Estimated)	Turnaround Time
PYLORI-CHEK Breath Test (¹³C-Urea)	¹³C-urea ingested. H. pylori urease hydrolyzes urea to ¹³CO₂ and ammonia. ¹³CO₂ exhaled and measured.	Non-invasive	95-98% / 90-95%	Moderate	15-30 minutes
Fecal Antigen Test (¹³C-Urea)	Detects H. pylori antigen in stool samples.	Non-invasive	90-95% / 85-95%	Moderate	Hours to days
Serology (Antibody Test)	Detects antibodies to H. pylori in blood.	Minimally Invasive	Varies; can remain positive after eradication	Low	Hours
Endoscopy with Biopsy	Visualizes the stomach lining and takes tissue samples for histology, rapid urease testing, or culture.	Invasive	90-99% / 95-99% (Histology)	High	Days to weeks

Source: Manufacturer data and published literature. Accuracy figures represent typical ranges and can vary by study and assay.

Advantages of PYLORI-CHEK:

• High Accuracy: Comparable to invasive methods for primary diagnosis.
• Non-Invasive: Avoids discomfort and risks associated with endoscopy.
• Rapid Results: Provides same-day diagnosis, enabling timely treatment initiation.
• Patient Comfort: Preferred by many patients over endoscopic procedures.

Limitations:

• Cost: Can be more expensive than serological tests.
• Proton Pump Inhibitors (PPIs): Patients must typically discontinue PPIs for a period before the test, as these can affect urease activity and lead to false negatives.
• ¹³C Availability: Requires a supply of ¹³C-labeled urea.

WHAT ARE THE INTELLECTUAL PROPERTY AND REGULATORY CONSIDERATIONS?

The patent landscape for H. pylori diagnostic methods, particularly breath tests, is characterized by patents covering specific compositions of labeled urea, detection methodologies, and device configurations.

Key Patent Areas:

• Labeled Urea Composition: Patents may claim specific isotopic labeling (e.g., ¹³C or ¹⁴C) of urea, or combinations of isotopes.
• Detection Technology: Claims can cover methods for analyzing breath samples, including mass spectrometry or infrared spectroscopy techniques used to quantify the labeled CO₂.
• Diagnostic Kits and Devices: Patents may protect the integrated systems for administering the urea and collecting/analyzing breath.
• Methods of Diagnosis: Claims can cover the specific protocol for performing the breath test, including patient preparation and interpretation of results.

Regulatory Status:

• FDA Approval: Diagnostic devices like PYLORI-CHEK require clearance or approval from regulatory bodies such as the U.S. Food and Drug Administration (FDA) for marketing. The specific pathway (e.g., 510(k) clearance or PMA) depends on the device's novelty and risk class.
• CE Marking: In Europe, devices must comply with the Medical Device Regulation (MDR) and obtain CE marking.
• Reimbursement: Obtaining favorable reimbursement codes and rates from healthcare payers (e.g., Medicare, private insurers) is critical for commercial adoption. This often involves demonstrating clinical utility and cost-effectiveness.

Example Patent Considerations:

• A patent might claim a method for detecting H. pylori infection comprising administering to a subject a dose of ¹³C-labeled urea, collecting a breath sample from the subject after a predetermined time, and measuring the isotopic ratio of carbon dioxide in the breath sample. [Hypothetical Patent Claim]
• Patents related to the specific ¹³C-urea formulation, its purity, or its stability could also be relevant.

Freedom to Operate: Companies developing or marketing PYLORI-CHEK or similar tests must conduct freedom-to-operate analyses to ensure they do not infringe on existing patents.

WHAT IS THE COMPETITIVE LANDSCAPE?

The H. pylori diagnostic market is served by several companies offering various testing modalities. Competition is driven by accuracy, speed, cost, and ease of use.

Key Competitors and Product Types:

• Breath Test Providers: Companies offering ¹³C-urea or ¹⁴C-urea breath tests. These include both established diagnostic companies and specialized firms.
• Fecal Antigen Test Manufacturers: Companies providing kits to detect H. pylori antigens in stool.
• Serology Kit Developers: Manufacturers of assays that detect IgG antibodies against H. pylori in serum or plasma.
• Endoscopy/Biopsy Service Providers: Hospitals and diagnostic laboratories performing invasive procedures and subsequent analysis.

Market Dynamics:

• Shift Towards Non-Invasive Methods: A general trend favors non-invasive diagnostics, positioning breath and fecal tests favorably.
• Point-of-Care Testing (POCT): Development of rapid POCT devices is a significant competitive factor, offering immediate results in clinical settings.
• Companion Diagnostics: Future developments may involve companion diagnostics linked to specific eradication therapies.
• Geographic Variations: Market penetration and preferred methods can differ significantly by region due to healthcare infrastructure, cost sensitivities, and regulatory frameworks.

WHAT ARE THE FINANCIAL AND INVESTMENT FUNDAMENTALS?

Investment analysis for PYLORI-CHEK requires evaluating its market penetration, revenue streams, cost structure, and growth potential against the backdrop of the broader H. pylori diagnostic market.

Revenue Streams:

• Direct Sales: Sale of test kits or complete diagnostic systems to hospitals, clinics, and independent laboratories.
• Service Fees: If the company operates its own reference laboratory, revenue can be generated from processing tests.
• Licensing: Potential revenue from licensing the technology to other diagnostic manufacturers.

Cost Structure:

• Manufacturing Costs: Cost of ¹³C-urea, reagents, and device components.
• Research and Development (R&D): Ongoing investment in assay improvement, new indications, or next-generation devices.
• Sales and Marketing: Costs associated with market penetration, physician education, and reimbursement efforts.
• Regulatory Compliance: Expenses related to maintaining regulatory approvals and audits.

Growth Drivers:

• Increasing Awareness: Growing understanding of H. pylori's link to serious diseases.
• Healthcare Policy: Government initiatives promoting early diagnosis and treatment of gastrointestinal disorders.
• Technological Advancement: Development of more accurate, faster, and user-friendly diagnostic tools.
• Emerging Markets: Expansion of diagnostic access in regions with high H. pylori prevalence.

Investment Considerations:

• Market Share: PYLORI-CHEK's current and projected market share within the breath test segment and the overall H. pylori diagnostic market.
• Reimbursement Landscape: The extent to which the test is covered by major payers and the average reimbursement rate.
• Intellectual Property Strength: The robustness and duration of the company's patent portfolio.
• Competitive Response: The ability of PYLORI-CHEK to maintain a competitive edge against emerging technologies and established players.
• Scalability: The capacity of manufacturing and distribution to meet increasing demand.

KEY TAKEAWAYS

• PYLORI-CHEK BREATH TEST addresses a significant unmet need in diagnosing H. pylori infections, linked to prevalent and serious gastrointestinal conditions.
• The test offers a highly accurate, non-invasive, and rapid alternative to traditional endoscopic methods.
• Intellectual property protection and successful navigation of regulatory pathways (e.g., FDA, CE) are critical for market exclusivity and commercial viability.
• The competitive landscape includes a range of diagnostic modalities, with a trend towards non-invasive and point-of-care solutions.
• Investment viability hinges on market share, reimbursement rates, patent strength, and the company's ability to scale operations.

FREQUENTLY ASKED QUESTIONS

1. What is the primary differentiator for PYLORI-CHEK BREATH TEST compared to other H. pylori diagnostic methods?
2. What are the main regulatory hurdles PYLORI-CHEK BREATH TEST has encountered or needs to address for broader market adoption?
3. How does the cost of PYLORI-CHEK BREATH TEST compare to the long-term economic impact of untreated H. pylori-related diseases?
4. What is the typical patient preparation protocol required before undergoing a PYLORI-CHEK BREATH TEST?
5. Are there any known contraindications for using PYLORI-CHEK BREATH TEST in specific patient populations?

CITATIONS

[1] Hooi, J. K. W., Lai, C. C., Ng, W. Q., Chen, M. W. W., Chan, W. W. L., Thung, K. F., ... & Tan, C. Y. (2017). Global prevalence of Helicobacter pylori infection: a systematic review and meta-analysis. Gastroenterology, 153(5), 1177-1187.e1171.

[2] Asombang, J. N., & El-Serag, H. B. (2013). Helicobacter pylori infection in the developing world: a review of the literature. Clinical Infectious Diseases, 57(Suppl_7), S461-S467.