BREATHTEK UBT FOR H-PYLORI Drug Patent Profile

« Back to Dashboard

Which patents cover Breathtek Ubt For H-pylori, and what generic alternatives are available?

Breathtek Ubt For H-pylori is a drug marketed by Otsuka America and is included in one NDA.

The generic ingredient in BREATHTEK UBT FOR H-PYLORI is urea c-13. There is one drug master file entry for this compound. Additional details are available on the urea c-13 profile page.

Summary for BREATHTEK UBT FOR H-PYLORI

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	120
DailyMed Link:	BREATHTEK UBT FOR H-PYLORI at DailyMed

US Patents and Regulatory Information for BREATHTEK UBT FOR H-PYLORI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001		DISCN	No	No

Expired US Patents for BREATHTEK UBT FOR H-PYLORI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001

# BreathTek UBT for H. pylori: Market Dynamics, Financial Trajectory, Patent Position and Competitive Outlook

Last updated: August 28, 2026

BreathTek UBT for H. pylori is a urea breath test marketed by Otsuka America Pharmaceutical Co. for the detection of active Helicobacter pylori infection. It is a diagnostic product, not a pharmaceutical drug. Its commercial model combines a single-use ^13C-urea test substrate with an analyzer-based measurement system. Otsuka does not publicly report BreathTek-specific revenue, operating profit, unit volume, or market share. The product’s financial trajectory must therefore be inferred from testing demand, reimbursement, installed equipment, clinical guidelines, and competition from stool-antigen, serology, endoscopic, and other breath-test methods.

What is BreathTek UBT for H. pylori?

BreathTek UBT is a noninvasive diagnostic test that detects active H. pylori infection through ingestion of ^13C-labeled urea. If H. pylori urease is present, the organism metabolizes urea and generates labeled carbon dioxide. The analyzer measures the isotope in exhaled breath.

Product attribute	Detail
Product	BreathTek UBT for H. pylori
Manufacturer	Otsuka America Pharmaceutical Co.
Active diagnostic substrate	^13C-urea
Diagnostic target	Active H. pylori infection
Test type	Noninvasive urea breath test
Primary clinical uses	Initial diagnosis and confirmation of eradication after treatment
Administration	Oral test substrate followed by breath collection and analyzer measurement
FDA pathway	Medical-device clearance or approval framework, not an NDA
Orange Book listing	Not applicable
Biosimilar status	Not applicable
Paragraph IV exposure	Not applicable

The test has a commercial advantage over antibody-based serology because it can detect active infection and can be used after treatment to confirm eradication. Stool-antigen testing is the closest lower-cost substitute for many outpatient settings.

What is the FDA regulatory status of BreathTek UBT?

BreathTek UBT is regulated as a diagnostic medical device rather than as a conventional prescription drug. Its regulatory profile is based on FDA device submissions, labeling, manufacturing controls, and post-market requirements. The FDA has authorized the use of urea breath testing for H. pylori detection under specified testing conditions.[1]

The product’s clinical value depends on proper medication and fasting restrictions. Proton-pump inhibitors, antibiotics, bismuth, and recent H. pylori treatment can produce false-negative results. Product labeling requires a medication washout period and a post-treatment interval before eradication testing.[2]

BreathTek’s regulatory position is commercially favorable because:

1. The test is established in clinical practice.
2. It has a defined use in both diagnosis and test-of-cure.
3. It is supported by professional guidance for confirming eradication.
4. It does not face the abbreviated new drug application process that applies to conventional drug products.

What is the market size for H. pylori diagnostic testing?

H. pylori testing is supported by a large global infection base. The bacterium infects roughly half of the world’s population, although prevalence varies substantially by geography, age, socioeconomic conditions, and sanitation.[3]

Demand is generated by:

• Dyspepsia and suspected peptic ulcer disease
• Previous peptic ulcer disease
• Gastric cancer risk management
• Unexplained iron-deficiency anemia in selected patients
• Initial diagnosis in primary care and gastroenterology
• Confirmation of eradication after antibiotic therapy

The U.S. market is more commercially attractive than a simple prevalence estimate suggests because treatment guidelines increasingly require confirmation of eradication. The American College of Gastroenterology recommends testing for cure after treatment using urea breath testing, fecal antigen testing, or biopsy-based testing, with testing performed after the appropriate medication and treatment intervals.[4]

The most important recurring demand segment is test-of-cure testing. Initial diagnosis creates one testing event. Confirmation of eradication creates a second event after treatment and may generate repeat testing when treatment fails.

How does BreathTek compare with stool-antigen and serology tests?

BreathTek competes on accuracy, convenience, active-infection detection, and physician familiarity. It competes against lower-cost stool-antigen testing on total cost and operational simplicity.

Attribute	BreathTek UBT	Stool-antigen test	Serology	Endoscopic biopsy testing
Detects active infection	Yes	Yes	Generally no	Yes
Useful for test of cure	Yes	Yes	No, generally unsuitable	Yes
Invasive	No	No	No	Yes
Collection burden	Breath samples and analyzer	Stool sample	Blood draw	Endoscopy
Equipment required	Analyzer	Laboratory platform or rapid assay	Laboratory platform	Endoscopy suite
Typical setting	Gastroenterology, hospitals, physician offices, laboratories	Primary care and laboratories	Limited diagnostic role	Patients already undergoing endoscopy
Main commercial advantage	Established, noninvasive active-infection test	Lower equipment burden and cost	Simple blood collection	Direct tissue evaluation
Main limitation	Analyzer and operational requirements	Patient reluctance and sample handling	Cannot reliably distinguish active from past infection	Cost and invasiveness

BreathTek’s analyzer requirement can create switching costs. Once a practice or laboratory installs compatible equipment, recurring demand for ^13C-urea test kits can support customer retention. The same requirement also limits adoption in low-volume practices.

What is the financial trajectory of BreathTek?

Otsuka does not separately disclose BreathTek revenue. The product is part of a diversified portfolio that includes prescription drugs, diagnostics, and other healthcare products. Public financial statements do not identify BreathTek sales, gross margin, installed analyzer base, or regional revenue.

The likely financial profile is a recurring consumables model:

Revenue component	Financial role
Single-use ^13C-urea kits	Recurring revenue tied to test volume
Analyzer placements or sales	Capital-equipment revenue and customer acquisition
Service and maintenance	Potential recurring support revenue
Laboratory and institutional contracts	Volume-based demand and retention
Physician-office testing	Higher convenience, but lower volume per site

Revenue is likely driven more by test utilization than by equipment sales after the installed base is established. The product’s financial trajectory should therefore be assessed through five operating indicators:

1. Number of active analyzers.
2. Tests performed per analyzer.
3. Reimbursement per completed test.
4. Consumable gross margin.
5. Share of test-of-cure volume versus initial diagnosis.

A mature diagnostic product can produce stable revenue even without rapid unit growth when clinicians continue to order eradication testing and installed analyzers generate repeat consumable purchases.

What reimbursement factors affect BreathTek UBT demand?

U.S. reimbursement is a central market variable. CPT code 83013 is associated with the H. pylori breath test analysis, while CPT code 83014 is associated with the breath test collection and preparation component.[5] Payment varies by payer, site of service, geographic locality, contract terms, and whether the service is performed in a physician office, hospital outpatient department, or independent laboratory.

Reimbursement pressure can affect adoption in three ways:

• Lower payment reduces laboratory and physician-office margins.
• Coverage restrictions can shift demand toward stool-antigen testing.
• Bundled or contracted laboratory pricing can reduce per-test revenue while preserving volume.

The product’s economic value is strongest when the provider can perform testing efficiently, obtain reliable reimbursement, and avoid referral delays associated with external laboratory testing.

What patents protect BreathTek UBT?

BreathTek’s principal commercial protection is not equivalent to a conventional pharmaceutical patent estate. The product is a diagnostic system involving ^13C-urea, sample collection, analyzer technology, software, labeling, quality systems, and manufacturing know-how.

The Orange Book does not list BreathTek because the Orange Book primarily identifies FDA-approved drug products and certain patent and exclusivity information associated with those products.[6] No conventional Orange Book patent expiry date should be used to model generic entry.

Potential forms of intellectual-property protection include:

• Patents covering isotope-based breath analysis
• Analyzer architecture and signal-processing methods
• Breath-collection devices
• Cartridge or reagent configurations
• Manufacturing processes for ^13C-urea
• Software and instrument calibration
• Trademarks, including the BreathTek brand
• Regulatory know-how and quality-control procedures

Publicly available information does not establish a current, complete patent-family schedule for all Otsuka BreathTek components. Patent expiration is therefore not a reliable standalone indicator of commercial loss. Competitors may enter with alternative ^13C-urea substrates, analyzers, laboratory workflows, or stool-antigen tests without copying the entire branded system.

When does BreathTek lose exclusivity?

BreathTek does not have a single drug-style exclusivity date. Its commercial exclusivity is layered:

Protection type	Relevance to BreathTek
New-drug exclusivity	Not the primary framework
Orange Book patents	Not applicable
Device patents	May protect specific analyzers, methods, or components
Trademark protection	Protects the BreathTek brand
Regulatory clearance	Does not create absolute market exclusivity
Manufacturing know-how	Can raise competitor entry costs
Installed-base economics	Can retain customers after patent expiry

The principal loss-of-exclusivity risk is functional substitution rather than a single generic launch. A competing breath-test platform, a lower-cost stool-antigen assay, or a laboratory-developed test can erode demand without infringing BreathTek patents.

Which companies challenge BreathTek in the market?

Competition comes from diagnostic manufacturers, clinical laboratories, hospital systems, and branded stool-antigen products. The competitive set includes:

• Meridian Bioscience and other H. pylori diagnostic suppliers
• Quest Diagnostics and Labcorp through laboratory testing services
• Hospital and academic laboratories
• Manufacturers of stool-antigen assays
• Developers of alternative urea breath-test analyzers
• Endoscopy centers offering biopsy-based testing

The competitive threat varies by customer. Large laboratories may prioritize throughput and cost. Gastroenterology practices may prioritize turnaround time and test-of-cure reliability. Primary-care offices may favor stool-antigen testing because it does not require a dedicated breath analyzer.

What generic entry risks exist for BreathTek?

Traditional generic entry risk is low because BreathTek is not an oral drug with an ANDA pathway. Substitution risk is moderate and arises from competing diagnostic technologies.

Higher-risk scenarios

• A lower-cost breath-test platform gains broad reimbursement.
• Stool-antigen testing becomes easier for patients and providers.
• Payers restrict reimbursement for office-based breath testing.
• The analyzer becomes obsolete or requires expensive maintenance.
• H. pylori treatment shifts toward testing pathways controlled by large laboratories.

Lower-risk scenarios

• Continued guideline emphasis on test-of-cure testing.
• Strong physician familiarity with urea breath testing.
• High analyzer utilization at gastroenterology practices.
• Stable reimbursement for CPT 83013 and 83014.
• Clinical demand for a noninvasive test with active-infection detection.

What patent litigation and settlement agreements affect BreathTek?

No major publicly established Paragraph IV litigation or drug-patent settlement framework applies to BreathTek. It is a diagnostic-device product, and the relevant disputes would more likely involve device patents, trade secrets, trademarks, regulatory compliance, or contract terms.

Public sources do not identify a current major patent settlement that determines BreathTek market entry. The absence of a disclosed drug-style litigation event means financial analysis should focus on technology competition, reimbursement, manufacturing, and customer retention rather than on a scheduled generic launch.

How strong is the BreathTek commercial position?

BreathTek has a durable but not unassailable position.

Strength	Assessment
Clinical utility	Strong for active infection and test of cure
Regulatory maturity	Strong
Brand recognition	Established in H. pylori breath testing
Recurring consumables	Favorable
Switching costs	Moderate because of analyzer deployment
Pricing power	Constrained by stool-antigen and laboratory alternatives
Patent visibility	Limited from public product-level disclosures
Generic-drug exposure	Low
Technology substitution risk	Moderate
Revenue transparency	Low because Otsuka does not report product-level sales

Key Takeaways

• BreathTek UBT is a diagnostic device system, not a conventional pharmaceutical drug.
• Otsuka does not publicly disclose product-specific revenue or profit.
• The product’s financial model depends on recurring ^13C-urea test-kit demand and analyzer utilization.
• Test-of-cure requirements support repeat demand after H. pylori treatment.
• Stool-antigen testing is the principal lower-cost substitute.
• Orange Book listing, Paragraph IV challenges, biosimilar exposure, and conventional drug exclusivity dates do not apply.
• Commercial protection depends on regulatory history, brand, installed analyzers, manufacturing know-how, and workflow integration.
• The primary downside risk is technology and reimbursement substitution, not a scheduled generic launch.

FAQs

Is BreathTek UBT a prescription drug?

No. BreathTek UBT is an FDA-regulated diagnostic medical-device system used to detect active H. pylori infection.

Does BreathTek UBT appear in the Orange Book?

No. The Orange Book is not the relevant exclusivity database for this diagnostic device.

Can patients use BreathTek UBT to confirm H. pylori eradication?

Yes. Urea breath testing is one of the accepted methods for confirming eradication after treatment, subject to medication washout and timing requirements.

Is there a generic version of BreathTek UBT?

There is no conventional generic drug version. Competing breath-test systems and stool-antigen assays can compete functionally with the product.

Does Otsuka report BreathTek sales separately?

No. Public Otsuka financial disclosures do not provide separate BreathTek revenue, volume, margin, or market-share figures.

References

1. U.S. Food and Drug Administration. (n.d.). H. pylori diagnostic testing and medical-device information. FDA.

2. Otsuka America Pharmaceutical Co. (n.d.). BreathTek UBT for H. pylori prescribing information and patient preparation instructions. Otsuka America Pharmaceutical Co.

3. Hooi, J. K. Y., Lai, W. Y., Ng, W. K., Suen, M. M. Y., Underwood, F. E., Tanyingoh, D., Malfertheiner, P., Graham, D. Y., Wong, V. W. S., Wu, J. C. Y., Chan, F. K. L., Sung, J. J. Y., Kaplan, G. G., & Ng, S. C. (2017). Global prevalence of Helicobacter pylori infection: Systematic review and meta-analysis. Gastroenterology, 153(2), 420-429.

4. Chey, W. D., Howden, C. W., Moss, S. F., Morgan, D. R., V. K. S., & others. (2024). ACG clinical guideline: Treatment of Helicobacter pylori infection. The American Journal of Gastroenterology.

5. American Medical Association. (2024). CPT code set: Urea breath testing codes 83013 and 83014. American Medical Association.

6. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.