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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:	81
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.

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			Y
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

International Patents for XENOVIEW

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

Country	Patent Number	Title	Estimated Expiration
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)
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)
Australia	2015218883	Hyperpolarized noble gas production systems with nanocluster suppression, detection and/or filtering and related methods and devices
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)

XENOVIEW Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XENOVIEW

Introduction

XENOVIEW, a revolutionary MRI technology developed by Polarean Imaging, is poised to transform the field of medical imaging, particularly in pulmonary diagnostics. Here, we delve into the market dynamics and financial trajectory of XENOVIEW, highlighting its growth potential, challenges, and key milestones.

Market Context

The global radiopharmaceutical and medical imaging markets are experiencing significant growth, driven by advancements in technology, increasing healthcare expenditures, and a rising demand for precision medicines. The radiopharmaceutical market, for instance, is projected to grow from USD 6.25 billion in 2023 to USD 14.38 billion by 2032, with a CAGR of 9.7%[1][4].

Technology Overview

XENOVIEW is a proprietary contrast agent used in Xenon MRI imaging, designed to illuminate hidden diseases non-invasively, particularly in the pulmonary vasculature. This technology has the potential to revolutionize medical imaging by enabling early intervention and improving patient outcomes[5].

Market Growth Drivers

Several factors are driving the growth of XENOVIEW in the market:

Clinical Applications

XENOVIEW is seeing increasing takeup in clinical and research settings due to its ability to provide detailed images of the lungs, which is crucial for diagnosing and monitoring pulmonary diseases. Key customers include prestigious institutions such as the University of Alabama at Birmingham Hospital, Cincinnati Children's Hospital Medical Center, and University of Missouri Health Care[5].

Regulatory Approvals

Polarean Imaging has secured significant regulatory milestones, including FDA approval in December 2022 and a key US patent for Xenon MRI imaging. These approvals expand the utility of XENOVIEW in diagnosing and monitoring diseases of the pulmonary vasculature[5].

Reimbursement

The approval of a new C-code from US Medicare, allowing for a total reimbursement of approximately $2,500, is a major incentive for hospitals to adopt XENOVIEW MRI technology. This reimbursement structure is expected to boost adoption rates and revenue growth[5].

Financial Trajectory

Current Financial Status

As of 2024, Polarean Imaging has a cash balance of US$6.1 million, which extends its cash runway into October 2024. The company has recently raised US$10 million through a placing and subscription of new shares, with significant investments from existing investors such as NUKEM Isotopes and Bracco Imaging[2][5].

Revenue Projections

Polarean Imaging expects revenues between US$2 million and US$3 million in 2024, a significant increase from less than US$1 million in 2023. By the end of 2025, the company anticipates having a total installed clinical base of 12-14 systems, performing 5-6 scans per week, with projected revenues of US$5-6 million. Profitability is expected by the second half of 2027, provided the FDA approves the gas exchange application for XENOVIEW[2][5].

Funding and Investment

The recent fundraise of US$10 million will be used to accelerate the commercialization of XENOVIEW, support continued investment in R&D, finalize the FDA plan for the gas exchange trial, develop new partnerships, and provide additional working capital. This funding is crucial for expanding the sales team and achieving commercial traction[5].

Challenges and Considerations

Capital Requirements

Polarean Imaging requires further capital to achieve its commercial targets. The company is seeking to initiate financing options in Q2 2024 to secure at least an additional US$10 million. While this need for capital may be seen as a challenge, it is viewed as part of the company's growth pains[2].

Regulatory and Clinical Trials

The success of XENOVIEW is contingent upon securing a gas exchange indication from the FDA. Polarean Imaging is working to finalize the FDA plan and conduct the associated clinical trial, which is expected to be a critical milestone in the technology's adoption[5].

Key Takeaways

• Regulatory Milestones: FDA approval and key US patent for Xenon MRI imaging are significant drivers of XENOVIEW's market growth.
• Financial Projections: Revenue growth from less than US$1 million in 2023 to US$5-6 million by 2025, with profitability expected by H2 2027.
• Funding and Investment: Recent US$10 million fundraise to support commercialization, R&D, and partnerships.
• Clinical Adoption: Increasing takeup in clinical and research settings, with key institutions already on board.
• Reimbursement: Favorable reimbursement structure from US Medicare, enhancing adoption and revenue.

FAQs

1. What is XENOVIEW and how does it work? XENOVIEW is a proprietary contrast agent used in Xenon MRI imaging to provide detailed images of the lungs, enabling early intervention and improved patient outcomes in pulmonary diseases.

2. What are the key regulatory milestones for XENOVIEW? XENOVIEW has secured FDA approval in December 2022 and a key US patent for Xenon MRI imaging, expanding its utility in diagnosing and monitoring pulmonary diseases.

3. How much funding has Polarean Imaging recently raised? Polarean Imaging has recently raised US$10 million through a placing and subscription of new shares, with significant investments from existing investors.

4. What are the revenue projections for XENOVIEW? Polarean Imaging expects revenues between US$2 million and US$3 million in 2024, increasing to US$5-6 million by 2025, with profitability expected by H2 2027.

5. What are the main challenges facing XENOVIEW's market growth? The main challenges include the need for further capital to achieve commercial targets and the contingent success on securing a gas exchange indication from the FDA.

Sources

1. Facts & Factors: Radiopharmaceutical Market Size, Industry Trends & Forecast to 2032.
2. Vox Markets: Polarean Imaging expects further growth and financing in 2024 as XENOVIEW footprint expands.
3. PubMed: Economics of new oncology drug development.
4. GlobeNewswire: Radiopharmaceuticals Market Size Worth USD 14.45 Billion in 2032.
5. Vox Markets: Polarean Imaging raises US$10m to support XENOVIEW.