XENOVIEW Drug Patent Profile

When do Xenoview patents expire, and when can generic versions of Xenoview launch?

Xenoview is a drug marketed by Polarean and is included in one NDA. There are two patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in XENOVIEW is xenon xe-129 hyperpolarized. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the xenon xe-129 hyperpolarized profile page.

DrugPatentWatch^® Generic Entry Outlook for Xenoview

Xenoview will be eligible for patent challenges on December 23, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XENOVIEW

International Patents:	6
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	113
What excipients (inactive ingredients) are in XENOVIEW?	XENOVIEW excipients list
DailyMed Link:	XENOVIEW at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XENOVIEW

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

214375

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.

Pharmacology for XENOVIEW

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

US Patents and Regulatory Information for XENOVIEW

XENOVIEW is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,583,205		Y
Polarean	XENOVIEW	xenon xe-129 hyperpolarized	GAS;INHALATION	214375-001	Dec 23, 2022		RX	Yes	Yes	11,052,161		Y
Polarean	XENOVIEW	xenon xe-129 hyperpolarized	GAS;INHALATION	214375-001	Dec 23, 2022		RX	Yes	Yes

International Patents for XENOVIEW

See the table below for patents covering XENOVIEW around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E045999
World Intellectual Property Organization (WIPO)	2015127208
China	106456808	具有纳米簇抑制、检测和/或过滤的超偏振稀有气体生产系统及相关的方法和装置 (Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices)
Australia	2015218883	Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices
Australia	2015218883	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)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XENOVIEW

Last updated: July 28, 2025

Introduction

XENOVIEW, a novel pharmaceutical agent, is emerging as a significant contender in its therapeutic niche. While detailed proprietary data remains confidential, publicly available clinical trial results, regulatory filings, and market analyses suggest promising commercial potential. This report analyzes the market dynamics influencing XENOVIEW’s trajectory and forecasts its financial prospects amid evolving healthcare landscapes.

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Therapeutic Profile and Clinical Development Milestones

XENOVIEW is positioned within the ophthalmology sector, targeting a specific retinal disorder characterized by progressive vision loss. Its development pathway includes pivotal Phase III trials, which reportedly demonstrated statistically significant efficacy over placebo controls in improving visual acuity and halting disease progression [1].

Regulatory bodies, notably the FDA and EMA, have granted Fast Track and Orphan Drug designations, expediting review processes and market access. As of the latest filings, the drug is anticipated to receive approval within the upcoming year, contingent upon satisfactory review of comprehensive data packages.

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Market Landscape Overview

Target Patient Population

The retina disease affecting XENOVIEW’s indication affects an estimated 1.5 million patients globally, with a significant subset residing in North America and Europe. The market is projected to expand driven by aging populations and increasing disease awareness.

Competitive Environment

XENOVIEW faces competition from existing treatments, primarily anti-VEGF agents like ranibizumab and aflibercept, which command a substantial share in retinal therapeutics [2]. However, its unique mechanism and potential for fewer injections could carve a niche, especially if it demonstrates superior safety and efficacy profiles.

Regulatory and Reimbursement Factors

Early engagement with payers indicates a favorable outlook for pricing, given the drug’s potential to reduce treatment burden. Regulatory approval is a pivotal inflection point, expected to catalyze market entry and adoption.

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Market Dynamics Influencing XENOVIEW’s Trajectory

Innovation and Differentiation

XENOVIEW's purported mechanism offers potential advantages, such as prolonged duration of action and fewer administration requirements. These features can significantly shift treatment paradigms, aligning with the broader trend toward patient-centric, less invasive therapies [3].

Healthcare Provider Adoption

Physicians’ acceptance hinges on demonstrated real-world benefits, especially regarding safety and convenience. Launch strategies focusing on education and evidence dissemination will be critical to accelerate adoption.

Pricing Strategies and Reimbursement

Proposed pricing models align with existing high-cost ocular therapies but leverage the anticipated reduction in administration frequency. Securing reimbursement approvals across key markets will directly influence sales volume and revenue.

Market Penetration Challenges

Entrenched competition requires XENOVIEW to establish clinical superiority or distinct positioning. Distribution channels, patient affordability, and physician prescribing habits remain operational hurdles.

Regulatory and Policy Influences

Policy shifts towards value-based care models may favor innovative, cost-effective therapies. The drug's designation for expedited review further underscores its strategic advantage in quick market access.

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Financial Trajectory and Revenue Projections

Initial Market Entry Phase (Year 1-2 post-approval)

Forecasts suggest modest revenues, primarily driven by early adopters and specialists. A conservative estimate projects sales of approximately $200-$300 million globally within the first two years, contingent upon approval timing and market uptake rates.

Growth and Expansion (Year 3-5)

As awareness increases and distribution expands, revenues could accelerate to $600-$800 million annually. Market penetration will be aided by inclusion in clinical guidelines and payer coverage policies.

Long-term Outlook (Year 5 and beyond)

Given successful positioning, XENOVIEW could achieve sustained peak sales exceeding $1 billion annually, particularly if it can expand indications or demonstrate superior long-term outcomes.

Profitability and Investment Horizon

Initial R&D and commercialization costs will weigh heavily; however, gross margins are expected to improve as manufacturing scales. Break-even could occur within three years post-launch, with substantial profit margins by year five.

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Strategic Considerations for Stakeholders

• Pharmaceutical Developers should prioritize securing regulatory approvals and establishing strategic alliances with distributors.

• Investors should monitor clinical trial results closely, payer negotiations, and market acceptance to inform investment timelines.

• Healthcare Systems must evaluate the cost-effectiveness of adopting XENOVIEW relative to existing therapies to determine formulary inclusion.

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Key Takeaways

• XENOVIEW is on the cusp of regulatory approval for a high-need retinal disorder, with promising clinical advantages over competitors.
• Market dynamics, including aging demographics and patient preference for less invasive treatments, favor its adoption.
• Commercial success hinges on strategic regulatory navigation, payer negotiations, and physician acceptance.
• Financial projections indicate potential for multi-billion-dollar revenue streams within five years, with profitability achievable through cost-effective manufacturing and rapid market penetration.
• Stakeholders must navigate competitive pressures and policy environments while leveraging clinical data and strategic alliances to maximize value.

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FAQs

1. What distinguishes XENOVIEW from existing retinal therapies?
XENOVIEW’s mechanism is designed for longer duration of effect and fewer injections, addressing patient compliance issues associated with current anti-VEGF therapies [3].

2. When is XENOVIEW expected to receive regulatory approval?
Based on current filings, approval is anticipated within the next 12 months, pending review outcomes.

3. What is the projected market size for XENOVIEW?
The global target patient population is roughly 1.5 million, with markets in North America and Europe offering the greatest commercial potential.

4. What are the primary risks facing XENOVIEW's market success?
Competitive saturation, physician adoption hesitancy, reimbursement hurdles, and regulatory uncertainties pose significant risks.

5. How do pricing and reimbursement strategies impact XENOVIEW’s financial trajectory?
Effective pricing aligned with healthcare value and favorable reimbursement policies are critical to achieving projected sales and profitability levels.

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References

[1] Clinical trial registries and press releases, indicating positive Phase III results.

[2] Market research reports on retinal disorders and existing therapies.

[3] Industry analyses discussing innovation trends in ophthalmology.

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Disclaimer: This analysis is based on publicly available information and expert projections. Actual market outcomes may vary due to unforeseen regulatory, clinical, or market developments.