UREA, C-14 - Generic Drug Details

What are the generic sources for urea, c-14 and what is the scope of freedom to operate?

Urea, c-14 is the generic ingredient in two branded drugs marketed by Avent and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for UREA, C-14

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
What excipients (inactive ingredients) are in UREA, C-14?	UREA, C-14 excipients list
DailyMed Link:	UREA, C-14 at DailyMed

US Patents and Regulatory Information for UREA, C-14

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avent	PYTEST KIT	urea, c-14	CAPSULE;ORAL	020617-002	May 9, 1997		DISCN	Yes	No
Avent	PYTEST	urea, c-14	CAPSULE;ORAL	020617-001	May 9, 1997		DISCN	Yes	No

Expired US Patents for UREA, C-14

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avent	PYTEST	urea, c-14	CAPSULE;ORAL	020617-001	May 9, 1997	4,830,010
Avent	PYTEST KIT	urea, c-14	CAPSULE;ORAL	020617-002	May 9, 1997	4,830,010

UREA, C-14: Market Landscape and Financial Projections

Last updated: February 19, 2026

What is UREA, C-14?

UREA, C-14 is a radiolabeled compound used primarily in medical diagnostics and research. It is a form of urea where the carbon atom is replaced with carbon-14, a radioactive isotope of carbon. This radioactive labeling allows researchers and clinicians to track the metabolic fate of urea in biological systems. Its main application is in the ¹³C-urea breath test, a non-invasive diagnostic method for detecting the presence of Helicobacter pylori (H. pylori) infection in the stomach [1]. H. pylori is a bacterium linked to peptic ulcers, gastritis, and gastric cancer. The test works by having the patient ingest a capsule containing UREA, C-14. If H. pylori is present, the bacteria metabolize the urea, releasing carbon dioxide enriched with carbon-14. This labeled carbon dioxide is absorbed into the bloodstream, transported to the lungs, and exhaled. A breath sample collected after a specific time period is analyzed for the presence of elevated levels of carbon-14 in the exhaled carbon dioxide, indicating an H. pylori infection [2].

What is the current market size and projected growth for UREA, C-14?

The global market for UREA, C-14 is directly tied to the prevalence of H. pylori infections and the adoption of diagnostic testing. Precise market size figures for UREA, C-14 as a standalone product are not readily disaggregated from broader diagnostic reagent markets. However, the market for H. pylori diagnostic tests is substantial and growing.

• Global Prevalence: H. pylori infection affects approximately 50% of the world's population, with higher rates in developing countries [3]. This widespread prevalence drives consistent demand for diagnostic solutions.
• Diagnostic Test Market: The global H. pylori diagnostic test market was valued at approximately USD 1.5 billion in 2022 and is projected to reach USD 2.1 billion by 2029, exhibiting a compound annual growth rate (CAGR) of around 5.2% [4]. UREA, C-14 based breath tests represent a significant segment of this market, often favored for their accuracy and non-invasiveness compared to invasive biopsy methods [5].
• Market Drivers:
  • Increasing awareness of H. pylori's link to gastrointestinal diseases.
  • Growing demand for non-invasive diagnostic procedures.
  • Technological advancements in breath test analyzers improving sensitivity and specificity.
  • Rising healthcare expenditure globally.
• Market Restraints:
  • Availability of alternative diagnostic methods, including stool antigen tests and serological tests, which can be lower cost in some regions.
  • Reimbursement policies and variations in healthcare system coverage.
  • The need for specialized equipment for breath sample analysis.

The demand for UREA, C-14 is expected to grow in tandem with the overall H. pylori diagnostic market. While specific growth rates for UREA, C-14 are not publicly itemized, its position as a key component in a widely used diagnostic method suggests a stable to moderate growth trajectory aligned with the broader market.

Who are the key manufacturers and suppliers of UREA, C-14?

The production and supply of radiolabeled compounds like UREA, C-14 require specialized manufacturing capabilities and adherence to strict regulatory controls for radioactive materials. The primary suppliers are typically specialized chemical and pharmaceutical companies.

Major Manufacturers and Suppliers (Examples):

• Campro Scientific GmbH: A German company specializing in radiolabeled compounds for research and diagnostics.
• Moravek Inc.: A US-based company that synthesizes and supplies radiochemicals, including isotope-labeled compounds.
• PerkinElmer Inc.: While a broader life sciences company, PerkinElmer offers a range of diagnostic reagents and isotopes, potentially including UREA, C-14 or its precursors, and associated analytical equipment.
• RayBio: A company offering various biochemicals and diagnostic kits, which may source or supply radiolabeled components.
• Specialized Radiopharmaceutical Companies: Numerous smaller, specialized companies globally focus on the production of isotopes and radiolabeled molecules for specific medical and research applications.

The supply chain for UREA, C-14 is concentrated among a limited number of producers due to the technical expertise and regulatory hurdles involved. This can lead to potential supply chain vulnerabilities if demand surges or if key manufacturers face production issues.

What is the regulatory landscape for UREA, C-14?

UREA, C-14 is classified as a radioactive material and a medical diagnostic agent, subjecting it to stringent regulations by national and international health and nuclear safety authorities.

• Radioactive Material Control:
  • International Atomic Energy Agency (IAEA): Sets international standards for the safety of radioactive sources and the transport of radioactive material. Member states often adopt these standards into their national legislation.
  • National Nuclear Regulatory Agencies: In the US, the Nuclear Regulatory Commission (NRC) regulates the possession, use, and transfer of radioactive materials. Similar agencies exist in other countries (e.g., the Office for Nuclear Regulation in the UK, the Canadian Nuclear Safety Commission).
  • Licensing Requirements: Manufacturers and distributors of UREA, C-14 must obtain specific licenses for the production, handling, and sale of radioactive materials. Users (hospitals, research institutions) also require licenses for possession and use.
• Pharmaceutical and Diagnostic Regulations:
  • Food and Drug Administration (FDA) in the US: Medical devices and diagnostic agents used in healthcare are regulated by the FDA. UREA, C-14 used in diagnostic kits falls under its purview, requiring pre-market approval or clearance depending on its classification.
  • European Medicines Agency (EMA) in Europe: Oversees the authorization of medicinal products and medical devices across the European Union.
  • Good Manufacturing Practices (GMP): Manufacturers are required to adhere to GMP standards to ensure the quality, purity, and consistency of UREA, C-14.
  • Radiopharmaceutical Regulations: Specific regulations govern radiopharmaceuticals, ensuring safety, efficacy, and quality control throughout their lifecycle. This includes requirements for synthesis, labeling, packaging, and distribution.
• Transportation Regulations:
  • Department of Transportation (DOT) in the US: Regulates the safe transport of hazardous materials, including radioactive substances.
  • International Air Transport Association (IATA) and International Maritime Dangerous Goods (IMDG) Code: Govern the international transport of dangerous goods by air and sea, respectively, including strict protocols for radioactive materials.

Compliance with these regulations adds significant cost and complexity to the production and distribution of UREA, C-14, acting as a barrier to entry for new manufacturers.

What are the key technological advancements impacting UREA, C-14 utilization?

While UREA, C-14 itself is a well-established chemical entity, advancements in diagnostic technology and analytical methods continue to influence its application and efficiency.

• Breath Analysis Technology:
  • Mass Spectrometry (MS): Advanced mass spectrometry techniques, such as Isotope Ratio Mass Spectrometry (IRMS) and Proton Transfer Reaction Mass Spectrometry (PTR-MS), offer increased sensitivity and specificity in detecting the ¹³C-enriched CO₂ in breath samples. This allows for earlier and more accurate diagnosis of H. pylori infection [6].
  • Infrared Spectroscopy: Newer infrared analyzers are becoming more compact, portable, and cost-effective, making breath testing more accessible in clinical settings, including point-of-care diagnostics [7].
• Kit Formulations and Ease of Use:
  • Pre-packaged Kits: Manufacturers are increasingly offering complete diagnostic kits that include the UREA, C-14 capsule, collection materials, and instructions, simplifying the testing procedure for healthcare providers and patients.
  • Improved Stability and Shelf-Life: Research into formulations that enhance the stability and extend the shelf-life of UREA, C-14 reagents reduces wastage and improves logistical efficiency.
• Minimization of Radioactive Dosage:
  • Ongoing research focuses on optimizing the dosage of UREA, C-14 required to achieve accurate results while minimizing patient exposure to radioactivity, aligning with ALARA (As Low As Reasonably Achievable) principles for radiation safety [8].
• Integration with Digital Health Platforms:
  • Future integration of breath test results with electronic health records (EHRs) and telemedicine platforms could streamline patient management and data analysis.

These technological advancements enhance the diagnostic performance and user experience of UREA, C-14 based tests, contributing to their continued relevance in H. pylori detection.

What are the financial considerations and investment outlook for companies involved with UREA, C-14?

Companies involved in the production, distribution, or application of UREA, C-14 operate within a niche but stable segment of the diagnostics market.

• Revenue Streams: Revenue is generated from the sale of UREA, C-14 as a raw material for diagnostic kits, or as part of complete diagnostic kits and associated analytical equipment.
• Cost Structure:
  • Raw Material Sourcing: Acquisition of carbon-14 isotopes is a significant cost factor, subject to availability and price fluctuations from specialized suppliers.
  • Manufacturing Overhead: Production requires specialized facilities, trained personnel, and adherence to strict GMP and radioactive material handling protocols, incurring substantial operational costs.
  • Regulatory Compliance: Obtaining and maintaining licenses, conducting quality control, and adhering to evolving regulations contribute significantly to expenses.
  • Research and Development: Investment in improving synthesis efficiency, developing more stable formulations, and supporting advancements in breath analysis technology is necessary for competitiveness.
• Profitability: Profit margins can be attractive due to the specialized nature of the product and the limited number of competitors. However, high capital expenditure for specialized facilities and ongoing R&D investment are crucial.
• Investment Outlook:
  • Stable Demand: The consistent prevalence of H. pylori infections provides a predictable and stable demand for UREA, C-14 based diagnostics.
  • Growth Potential: Growth is linked to the expansion of the H. pylori diagnostic market, driven by increased awareness, access to healthcare, and technological improvements that enhance diagnostic utility.
  • Acquisition Targets: Companies with proprietary manufacturing processes, strong regulatory approvals, or established distribution networks in this niche could be attractive acquisition targets for larger diagnostic or pharmaceutical firms seeking to broaden their portfolios.
  • Risks: Supply chain disruptions for carbon-14 isotopes, stricter regulatory requirements, or the emergence of superior, cost-effective alternative diagnostic technologies could pose risks.

Investment in companies focused on UREA, C-14 production or its associated diagnostic platforms is likely to yield steady returns, particularly for those demonstrating robust supply chains, efficient manufacturing, and strong regulatory compliance.

What are the competitive dynamics and market positioning of UREA, C-14?

The competitive landscape for UREA, C-14 is characterized by a specialized supply chain and a reliance on its established efficacy in H. pylori diagnostics.

• Market Dominance: The market for UREA, C-14 itself is not characterized by dominant players in the same way as broad pharmaceutical markets. Instead, a few specialized chemical synthesis companies supply the material.
• Diagnostic Kit Competition: Competition is more pronounced at the diagnostic kit level, where various companies offer H. pylori testing solutions.
  • UREA, C-14 Breath Test Providers: Companies that integrate UREA, C-14 into their breath test kits compete based on accuracy, speed of results, ease of use, cost, and the sophistication of their associated breath analyzers.
  • Alternative Diagnostic Methods: UREA, C-14 based tests compete with other H. pylori diagnostic methods, including:
    • Stool Antigen Tests: Non-invasive, enzyme-linked immunosorbent assays (ELISA) that detect H. pylori antigens in stool. These are often considered a primary screening tool in many regions due to lower cost and accessibility.
    • ¹³C-Urea Breath Test (¹³C-UBT): Uses a stable isotope (carbon-13) instead of a radioactive one. It offers similar diagnostic accuracy without the regulatory burden of radioactive materials, making it increasingly popular. However, the initial cost of ¹³C-UBT analyzers can be higher [9].
    • Serological Tests (Blood Tests): Detect antibodies to H. pylori. These are less reliable for active infection as antibodies can persist long after the bacteria are eradicated.
    • Endoscopy with Biopsy: Considered the gold standard for confirming infection and assessing gastric pathology, but is invasive and carries higher risks and costs.
• Market Positioning of UREA, C-14:
  • Established Efficacy: UREA, C-14 based breath tests have a long history of clinical validation and are known for their high sensitivity and specificity.
  • Non-Invasive Advantage: Their non-invasive nature is a significant advantage over endoscopy.
  • Radioactive Concerns: The primary disadvantage is the use of a radioactive isotope, which necessitates specialized handling, licensing, and disposal, adding complexity and cost compared to non-radioactive alternatives like ¹³C-UBT.
  • Cost-Effectiveness: In some healthcare systems, UREA, C-14 breath tests may offer a more cost-effective diagnostic pathway compared to initial endoscopy.

The market positioning of UREA, C-14 is that of a proven, albeit regulated, diagnostic agent whose future competitiveness will depend on its ability to maintain accuracy and cost-effectiveness against the rising adoption of non-radioactive isotopic breath tests and other diagnostic modalities.

Key Takeaways

• UREA, C-14 is a radiolabeled compound essential for the ¹³C-urea breath test, a primary diagnostic tool for Helicobacter pylori infections.
• The market for UREA, C-14 is intrinsically linked to the global H. pylori diagnostic market, projected to grow at a CAGR of approximately 5.2% to USD 2.1 billion by 2029.
• Production is concentrated among specialized chemical and radiopharmaceutical companies requiring significant regulatory compliance and technical expertise.
• Stringent national and international regulations govern its handling, use, and disposal as a radioactive material and medical diagnostic agent.
• Technological advancements in breath analysis (MS, infrared spectroscopy) enhance the performance of UREA, C-14 based tests.
• Financial prospects are tied to stable demand from H. pylori diagnostics, with profitability influenced by specialized manufacturing costs and regulatory adherence.
• UREA, C-14 faces competition from non-radioactive stable isotope breath tests (¹³C-UBT) and other diagnostic methods, with its market position dependent on its established accuracy and cost-effectiveness despite radioactive concerns.

Frequently Asked Questions

1. What are the primary applications of UREA, C-14 beyond H. pylori detection? While H. pylori detection is its dominant application, UREA, C-14 is also utilized in various research settings to study nitrogen metabolism, urea cycle function, and drug metabolism pathways in preclinical and clinical research. Its ability to track a specific molecule in biological systems makes it a valuable tracer for metabolic studies.

2. How does the regulatory burden for UREA, C-14 compare to non-radioactive isotopes like ¹³C? The regulatory burden for UREA, C-14 is significantly higher. It involves licensing for radioactive material handling, strict protocols for radiation safety, specialized disposal procedures for radioactive waste, and transportation regulations for radioactive substances. ¹³C, a stable isotope, does not carry these radioactive material specific regulations, simplifying its use and reducing associated compliance costs and logistical challenges.

3. What is the expected lifespan of UREA, C-14 as a primary diagnostic tool for H. pylori? UREA, C-14 is expected to remain a significant diagnostic tool for H. pylori for the foreseeable future due to its established efficacy, high sensitivity, and specificity, and its relatively lower cost compared to some initial equipment investments for alternative methods. However, the increasing adoption of ¹³C-urea breath tests, which offer similar diagnostic capabilities without the radioactive burden, represents a growing competitive threat that may gradually influence its market share over the long term.

4. What are the main logistical challenges in the supply chain for UREA, C-14? The main logistical challenges include the secure sourcing of carbon-14 isotopes, which have limited suppliers; the stringent requirements for the safe transportation of radioactive materials, involving specialized packaging and handling; and the need for timely delivery to end-users who also require appropriate licensing and storage for radioactive substances. Shelf-life and proper storage conditions for radiolabeled compounds also add to logistical complexities.

5. Are there any emerging diagnostic technologies that could potentially displace UREA, C-14 breath tests entirely? While no single technology has entirely displaced UREA, C-14 breath tests, advancements in molecular diagnostics and improved point-of-care testing platforms for other H. pylori detection methods, such as highly sensitive stool antigen tests and potentially novel biomarker detection in breath or other bodily fluids, are continually emerging. The increasing accessibility and decreasing cost of non-radioactive ¹³C-urea breath tests are also a direct challenge to the continued dominance of UREA, C-14 based methods.

Citations

[1] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). H. pylori/Urea Breath Test. Retrieved from https://www.niddk.nih.gov/health-information/diagnostic-tests/h-pylori-urea-breath-test

[2] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). H. pylori/Urea Breath Test. Retrieved from https://www.niddk.nih.gov/health-information/diagnostic-tests/h-pylori-urea-breath-test

[3] Hooi, J. K. W., Lai, C. C., Ng, W. K., Lam, J. R., Ding, X. D., Li, P. T., ... & Graham, D. Y. (2017). Global prevalence of Helicobacter pylori infection: a systematic review and meta-analysis. Gastroenterology, 153(2), 420-429.e19.

[4] Grand View Research. (2023). H. pylori Diagnostic Tests Market Size, Share & Trends Analysis Report By Type (Urea Breath Tests, Stool Antigen Tests, Blood Tests, Biopsy Tests), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/h-pylori-diagnostic-tests-market

[5] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). H. pylori/Urea Breath Test. Retrieved from https://www.niddk.nih.gov/health-information/diagnostic-tests/h-pylori-urea-breath-test

[6] Ko, G. Y., Kim, B. Y., Park, S. H., Kang, H. Y., Cheong, J. Y., Kim, J. H., ... & Kim, D. H. (2016). Comparison of different breath test analyzers for Helicobacter pylori infection. Journal of Neurogastroenterology and Motility, 22(2), 312-318.

[7] Votter, R. A., van der Veen, J. M., & de Boer, M. H. (2012). Non-invasive diagnosis of Helicobacter pylori infection. Digestive and Liver Disease, 44(5), 370-375.

[8] International Atomic Energy Agency. (2004). Radiation Protection and Safety of Radiation Sources: International Basic Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. IAEA Safety Standards Series No. GSR Part 3.

[9] Saffari, R., Bahrami, M., Bahrami, Z. (2019). Helicobacter pylori infection: Diagnosis and Treatment. Journal of Baqiyatallah University of Medical Sciences, 1(1), 1-9.