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Last Updated: December 13, 2025

Xenon xe-133 - Generic Drug Details


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What are the generic sources for xenon xe-133 and what is the scope of freedom to operate?

Xenon xe-133 is the generic ingredient in three branded drugs marketed by Curium, Ge Healthcare, Gen Electric, Lantheus Medcl, and Mallinckrodt, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for xenon xe-133. Two suppliers are listed for this compound.

Summary for xenon xe-133
US Patents:0
Tradenames:3
Applicants:5
NDAs:7
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 7
What excipients (inactive ingredients) are in xenon xe-133?xenon xe-133 excipients list
DailyMed Link:xenon xe-133 at DailyMed
Pharmacology for xenon xe-133

US Patents and Regulatory Information for xenon xe-133

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gen Electric XENON XE 133 xenon xe-133 GAS;INHALATION 017550-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare XENON XE 133 xenon xe-133 GAS;INHALATION 017687-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lantheus Medcl XENON XE 133 xenon xe-133 INJECTABLE;INJECTION 017283-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Xenon Xe-133

Last updated: July 28, 2025


Introduction

Xenon Xe-133, a radioactive isotope primarily used in diagnostic imaging, plays a crucial role in pulmonary ventilation imaging. Its unique characteristics—short half-life, inert nature, and reliable imaging properties—have established it as an indispensable tool in nuclear medicine. While not a traditional pharmaceutical in the clinical sense, Xe-133's market dynamics and financial trajectory are driven by healthcare trends, technological advances, regulatory pathways, and emerging applications. This comprehensive analysis explores these factors, delineating current market drivers, projected growth trends, challenges, and opportunities.


Market Overview of Xe-133 in Nuclear Medicine

Xe-133’s dominant application in ventilation scintigraphy stems from its ability to visualize airflow and gas exchange within the lungs. Its gaseous form permits non-invasive inhalation procedures, offering real-time functional assessments crucial for diagnosing conditions like chronic obstructive pulmonary disease (COPD), pulmonary embolism, and asthma.

The global nuclear medicine market, estimated at approximately USD 4.3 billion in 2022, is expected to expand at a compound annual growth rate (CAGR) of 5-7% through the next decade, with Xe-133 occupying a stable niche within pulmonary imaging segments [1].

Key players include specialized radiopharmaceutical providers, nuclear medicine departments in hospitals, and imaging laboratories. The supply chain comprises isotope production facilities, radiochemistry laboratories, and distribution networks optimized for short-lived isotopes.


Market Drivers

1. Rising Prevalence of Pulmonary Diseases
The global burden of respiratory illnesses such as COPD, asthma, and pulmonary embolism underpins demand for functional lung imaging. According to WHO, COPD affects over 200 million people worldwide, with incidence rising due to aging populations and environmental factors [2].

2. Advances in Nuclear Imaging Technology
Modern imaging modalities increasingly leverage Xe-133's unique properties. Innovations in SPECT (Single Photon Emission Computed Tomography) and PET (Positron Emission Tomography) imaging enhance diagnostic accuracy, prompting wider clinical adoption.

3. Clinical Guidelines Favoring Non-Invasive Pulmonary Assessment
Leading health authorities and pulmonology guidelines endorse gas ventilation imaging for comprehensive lung assessment, bolstering utilization rates.

4. Growing Healthcare Expenditure and Technological Adoption in Emerging Markets
Emerging economies are investing in advanced diagnostic infrastructure, expanding the reach of nuclear medicine and Xe-133-based diagnostics.


Market Challenges

1. Production and Supply Limitations
Xe-133 is produced via neutron activation of precursor isotopes in research reactors. Restricted reactor availability, regulatory hurdles, and high production costs pose supply constraints. Short half-life (approximately 5.3 days) complicates logistics, demanding efficient distribution channels.

2. Competition from Alternative Modalities
Emerging imaging agents, MRI techniques, and CT-based assessments provide non-radioactive or less resource-dependent options, potentially limiting Xe-133’s market share.

3. Regulatory Barriers
Regulatory approval processes for new applications or formulations can delay commercialization. The radioactive nature mandates stringent safety protocols, raising compliance costs.

4. Safety and Environmental Concerns
Radioactive waste management and radiation safety considerations influence hospital procurement and patient acceptance.


Financial Trajectory and Investment Outlook

1. Revenue Projections
Given stable demand, the Xe-133 segment primarily generates revenue for specialized radiopharmaceutical firms. The revenue potential is tied closely to pulmonary diagnostic volume growth, which is expected to grow in sync with respiratory disease prevalence.

2. R&D and Market Expansion Opportunities
Development of technological innovations—such as permanent generator systems, improved imaging software, and alternative production methods—can unlock new revenue streams.

3. Market Penetration in Emerging Markets
As healthcare systems expand diagnostics capabilities, Xe-133’s adoption is poised for acceleration, especially where pulmonary diseases are prevalent. Strategic partnerships with local distributors can enhance market penetration.

4. Impact of Regulatory Developments
Streamlining approval pathways and harmonizing international standards could lower barriers, fostering increased commercialization and investment.

5. Competitive Landscape
Though few companies dominate Xe-133 supply, market dynamics will be influenced by entrants offering technological innovations or alternative isotopes. Assessing the investment risk involves monitoring geopolitical stability of reactor facilities and regulatory environments.


Emerging Trends and Future Prospects

1. Novel Production Technologies
Research into accelerator-based production of Xe-133 could reduce dependence on neutron reactors, lowering costs and expanding supply capacity.

2. Integration with Advanced Imaging Modalities
Combining Xe-133 ventilation imaging with other functional imaging approaches broadens diagnostic utility, potentially increasing demand and revenues.

3. Personalized Pulmonary Diagnostics
The shift toward personalized healthcare opens avenues for tailored imaging protocols utilizing Xe-133, supporting premium service offerings and higher margins.

4. Environmental and Safety Innovations
Development of safer, more efficient waste management and radiation shielding techniques will strengthen market confidence and facilitate expansion.


Regulatory and Market Outlook

The regulatory environment remains complex, with approval processes varying across regions. Agencies like the U.S. FDA and EMA monitor nuclear medicine products stringently, but recent initiatives aim at harmonization. The expanding global burden of respiratory ailments and advancements in diagnostic technologies reinforce a positive long-term outlook for Xe-133.

Market assessments predict steady growth driven by clinical demand, technological innovation, and strategic initiatives by key industry players. Nonetheless, supply constraints and regulatory hurdles necessitate continuous innovation and strategic agility.


Key Takeaways

  • Demand is driven by rising respiratory disease prevalence and improvements in lung imaging technology.
  • Supply constraints due to reactor dependence and logistical challenges remain significant market barriers.
  • Emerging production methods, such as accelerator-based techniques, hold potential to stabilize and expand supply chains.
  • Expanding use in emerging markets offers growth opportunities amidst improving healthcare infrastructure.
  • Regulatory harmonization and technological innovation will be pivotal to unlocking future market growth and financial sustainability.

FAQs

Q1: What are the primary clinical applications of Xe-133 in nuclear medicine?
A1: Xe-133 is mainly used for pulmonary ventilation imaging to assess airflow and lung function in conditions like COPD, asthma, and pulmonary embolism.

Q2: How does the short half-life of Xe-133 affect its market and logistics?
A2: The 5.3-day half-life necessitates rapid production, distribution, and use. This short window limits inventory buildup and demands an efficient supply chain infrastructure.

Q3: What technological innovations could influence Xe-133’s market growth?
A3: Advances in generator technology, accelerator-based production, and integrated imaging software can minimize costs, improve supply, and enhance diagnostic accuracy.

Q4: How does the regulatory landscape impact Xe-133 commercialization?
A4: Stringent safety standards and approval processes can delay market entry and increase compliance costs, but efforts toward regulatory harmonization may streamline approvals.

Q5: What is the outlook for Xe-133 in emerging markets?
A5: As healthcare systems improve and respiratory disease burdens rise, demand for lung ventilation imaging, including Xe-133, is expected to grow, offering significant growth opportunities.


References

[1] MarketsandMarkets. (2022). Nuclear Medicine Market by Product & Service, Application, End User, and Region - Global Forecast to 2027.
[2] World Health Organization. (2021). Global surveillance, prevention, and control of chronic respiratory diseases.

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