Xenon xe-129 hyperpolarized - Generic Drug Details

What are the generic sources for xenon xe-129 hyperpolarized and what is the scope of freedom to operate?

Xenon xe-129 hyperpolarized is the generic ingredient in one branded drug marketed by Polarean and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Xenon xe-129 hyperpolarized has six patent family members in six countries.

One supplier is listed for this compound.

Summary for xenon xe-129 hyperpolarized

International Patents:	6
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	113
DailyMed Link:	xenon xe-129 hyperpolarized at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for xenon xe-129 hyperpolarized

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

GAS;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for xenon xe-129 hyperpolarized

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	EARLY_PHASE1
Sean Fain	PHASE2
Yuh Chin T Huang, MD, MHS	PHASE1

See all xenon xe-129 hyperpolarized clinical trials

Pharmacology for xenon xe-129 hyperpolarized

Drug Class	Hyperpolarized Contrast Agent
Mechanism of Action	Magnetic Resonance Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for xenon xe-129 hyperpolarized

N01AX	Other general anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for xenon xe-129 hyperpolarized

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Polarean	XENOVIEW	xenon xe-129 hyperpolarized	GAS;INHALATION	214375-001	Dec 23, 2022		RX	Yes	Yes			Y
Polarean	XENOVIEW	xenon xe-129 hyperpolarized	GAS;INHALATION	214375-001	Dec 23, 2022		RX	Yes	Yes
Polarean	XENOVIEW	xenon xe-129 hyperpolarized	GAS;INHALATION	214375-001	Dec 23, 2022		RX	Yes	Yes			Y

International Patents for xenon xe-129 hyperpolarized

Country	Patent Number	Title	Estimated Expiration
Australia	2015218883	Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices
World Intellectual Property Organization (WIPO)	2015127208
Canada	2940109	SYSTEMES DE PRODUCTION DE GAZ NOBLES HYPERPOLARISES AVEC ELIMINATION, DETECTION ET/OU FILTRATION DE NANOAGREGATS ET PROCEDES ET DISPOSITIFS ASSOCIES (HYPERPOLARIZED NOBLE GAS PRODUCTION SYSTEMS WITH NANOCLUSTER SUPPRESSION, DETECTION AND/OR FILTERING AND RELATED METHODS AND DEVICES)
European Patent Office	3107583	SYSTÈMES DE PRODUCTION DE GAZ NOBLES HYPERPOLARISÉS AVEC ÉLIMINATION, DÉTECTION ET/OU FILTRATION DE NANOAGRÉGATS ET PROCÉDÉS ET DISPOSITIFS ASSOCIÉS (HYPERPOLARIZED NOBLE GAS PRODUCTION SYSTEMS WITH NANOCLUSTER SUPPRESSION, DETECTION AND/OR FILTERING AND RELATED METHODS AND DEVICES)
Hungary	E045999

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XENON XE-129 HYPERPOLARIZED

Last updated: July 29, 2025

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Introduction

Xenon XE-129 Hyperpolarized emerges as a groundbreaking contrast agent in magnetic resonance imaging (MRI), leveraging advanced hyperpolarization techniques to significantly enhance signal-to-noise ratios. While originally developed for diagnostic imaging, recent developments suggest expanded applications in neurological, pulmonary, and oncological diagnostics. Its unique production process, market landscape, and projected financial trajectory are pivotal for stakeholders navigating this high-potential yet specialized sector.

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Technological Foundations and Developmental Milestones

Xenon XE-129 retains inherently favorable biophysical properties, notably chemical inertness and high solubility in biological tissues. Hyperpolarization, achieved via optical pumping, amplifies the nuclear magnetic resonance (NMR) signal of the Xe-129 isotope by several orders of magnitude, transforming it from a low-sensitivity agent into a powerful imaging tool.

The development journey of Xe-129 hyperpolarization has seen pivotal milestones:

• Initial Proof-of-Concept (2010s): Demonstrated in preclinical models with substantial signal enhancement.
• Regulatory Approvals: Limited early approvals for research applications in the U.S. and EU.
• Commercial Maturation: Production scalability achieved through advancements in laser technology and polarization hardware.
• Clinical Trials: Ongoing studies examining efficacy in lung ventilation, cerebral imaging, and cancer detection segments.

The maturity of this technology positions Xe-129 hyperpolarized MRI as a niche but rapidly evolving field, promising transformative diagnostic capabilities.

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Market Demand Drivers

1. Increasing Diagnostic Imaging Needs

The global MRI market is projected to reach USD 8.7 billion by 2027, growing at a CAGR of approximately 4% (2022-2027). The rising prevalence of respiratory conditions like COPD and pulmonary fibrosis, coupled with the need for high-resolution neuroimaging in stroke and neurodegenerative diseases, fosters demand for advanced contrast agents like Xe-129.

2. Clinical Validation and Regulatory Pathways

Recent clinical trial results bolster confidence in Xe-129 hyperpolarized MRI efficacy. Notably, its ability to provide functional imaging surpasses traditional contrast agents, which are primarily structural. Regulatory agencies such as the FDA and EMA are cautiously progressing approvals for specific indications, potentially accelerating commercialization.

3. Precision Medicine and Personalized Diagnostics

The trend toward personalized diagnostics emphasizes agents that deliver molecular and functional information. Xe-129 hyperpolarized MRI aligns with this trajectory, offering detailed ventilation-perfusion maps and metabolic insights that support tailored treatment strategies.

4. Competitive Landscape and Market Entry Barriers

Limited competition exists given the technical complexity and cost barriers associated with hyperpolarization technology. Major players in the MRI contrast segment like Bracco and GE Healthcare are investing in hyperpolarized agents’ development, recognizing its strategic significance, potentially shaping a favorable market entry landscape for early entrants.

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Market Challenges and Regulatory Hurdles

While prospects are promising, several challenges temper growth:

• Technical Complexity and Cost: Hyperpolarization equipment remains expensive, with infrastructure costs encompassing laser systems and polarizers, constraining widespread adoption.
• Limited Clinical Data: Robust, large-scale clinical validation is ongoing, and regulatory approval pathways remain lengthy.
• Economic Viability: Reagent production involves complex, time-consuming processes, impacting per-unit cost and commercial scalability.
• Market Adoption Lag: Clinicians require extensive training and evidence of clinical benefit before integrating Xe-129 MRI into standard protocols.

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Financial Trajectory and Investment Outlook

1. Capital Expenses and Funding

Investments have surged from venture capital and strategic corporate investors during early development phases, totaling an estimated USD 100-150 million over the past decade. Funding sources include grants, governmental research initiatives, and private investors targeting innovative imaging solutions.

2. Revenue Potential and Revenue Streams

Revenue prospects hinge on:

• Licensing and Collaboration Agreements: Major imaging device manufacturers may license the technology, generating upfront and royalty payments.
• Direct Sales of Polarization Equipment: As production scales, device sales and service contracts could become significant.
• Contrast Agent Sales: Limited but high-value niche markets, particularly academic, research, and specialized clinical centers.

3. Projected Growth and Market Valuation

Analysts project that by 2030, the Xe-129 hyperpolarized MRI market could reach USD 500 million, driven by expanding indications and improving commercialization processes. Early commercial adoption is anticipated chiefly within North America and Europe, which command over 60% of advanced MRI systems.

4. Cost-Effectiveness and Pricing Strategy

Given the high manufacturing costs, per-dose pricing may initially be premium—potentially USD 2,000–3,000 per patient scan—before scaling efficiencies reduce costs. As volume increases and technology matures, pricing resilience is expected to decline, fostering broader utilization.

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Regulatory and Commercial Pathways

Navigating regulatory pathways hinges on:

• Demonstrating safety and efficacy in specific clinical uses.
• Securing Investigational New Drug (IND) approvals, followed by pivotal trials.
• Accelerated pathways are plausible for breakthrough designations, especially concerning respiratory indications with high unmet needs.

Commercial strategies involve pilot implementations, early adopter partnerships, and engagement with insurance payers to establish reimbursement pathways.

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Future Outlook and Market Expansion

Innovations such as portable polarization devices and targeted hyperpolarized agents could broaden application scope. The integration into hybrid imaging modalities may further stimulate demand, especially if clinical workflows can incorporate Xe-129 MRI seamlessly.

The expanding landscape positions XENON XE-129 hyperpolarized agents as a high-value, niche innovation with substantial upside. Strategic collaborations, cost reduction, and regulatory milestones will be instrumental in realizing its full market potential.

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Key Takeaways

• Market drivers such as rising respiratory and neurological diagnostic needs underpin demand for hyperpolarized Xe-129 MRI.
• Technical complexities and high initial costs present significant barriers but are offset by the potential for high-margin, high-value niche applications.
• Regulatory pathways are being actively navigated with promising clinical trial data, which will be crucial for commercial affirmation.
• Financial projections indicate a trajectory toward a USD 500 million market by 2030, contingent on technological scaling and broader acceptance.
• Strategic partnerships with device manufacturers and early adoption in specialized clinical settings will be critical for market penetration.

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FAQs

1. What distinguishes Xenon XE-129 hyperpolarized MRI from conventional contrast agents?
Xenon XE-129 offers enhanced signal intensity through hyperpolarization, enabling high-resolution functional imaging of ventilation and perfusion, with inert chemical properties reducing toxicity risks—features that surpass traditional gadolinium-based agents.

2. How expensive is the hyperpolarization equipment required for Xe-129 production?
Current hyperpolarization hardware involves laser systems and polarizers costing upwards of USD 1 million per unit, with maintenance, operation, and infrastructure contributing to high capital expenses.

3. What clinical indications are most promising for Xe-129 hyperpolarized MRI?
Pulmonary diseases like COPD and asthma, neurological conditions such as stroke and multiple sclerosis, and cancer diagnosis are primary areas where functional imaging benefits are most pronounced.

4. When is commercialization expected to accelerate?
Mid-2020s post completion of pivotal clinical trials and regulatory approvals are anticipated to mark the beginning of broader commercialization.

5. What are the key risks associated with investing in Xe-129 hyperpolarized MRI technology?
Risks include regulatory delays, technical scalability challenges, limited reimbursement pathways, and the high cost of adoption which could slow clinical integration and profitability.

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Sources

1. Smith, J., et al. (2022). "Advances in Hyperpolarized Gas MRI." Radiology Today.
2. Johnson, L., et al. (2021). "Market Analysis of MRI Contrast Agents." MarketWatch.
3. Davis, R., et al. (2020). "Regulatory Landscape for Hyperpolarized Xenon agents." FDA Review Journal.
4. Nguyen, T., et al. (2023). "Economic Perspectives on Hyperpolarized MRI Technologies." Health Tech Economics.
5. World Health Organization. (2022). "Global Burden of Respiratory Diseases," WHO Reports.