MYOVIEW 30ML Drug Patent Profile

Which patents cover Myoview 30ml, and when can generic versions of Myoview 30ml launch?

Myoview 30ml is a drug marketed by Medi-physics and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in MYOVIEW 30ML is technetium tc-99m tetrofosmin kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tetrofosmin kit profile page.

DrugPatentWatch^® Generic Entry Outlook for Myoview 30ml

Myoview 30ml was eligible for patent challenges on February 9, 2000.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYOVIEW 30ML

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
DailyMed Link:	MYOVIEW 30ML at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYOVIEW 30ML

NDA:

020372

Dosage:

INJECTABLE;INJECTION

^*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 MYOVIEW 30ML

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

Sponsor	Phase
Astellas Pharma Inc	Phase 2
GE Healthcare	Phase 4

See all MYOVIEW 30ML clinical trials

US Patents and Regulatory Information for MYOVIEW 30ML

MYOVIEW 30ML is protected by one US patents.

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
Medi-physics	MYOVIEW 30ML	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372-002	Jul 7, 2005		RX	Yes	Yes			Y

International Patents for MYOVIEW 30ML

When does loss-of-exclusivity occur for MYOVIEW 30ML?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Hong Kong

Japan

Spain

United Kingdom

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

See the table below for additional patents covering MYOVIEW 30ML around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	171416
Japan	H0222286	LIGAND AND CATION COMPLEX THEREOF WITH TECNETIUM-99M
Denmark	163289
South Korea	0149439
China	1079746

Supplementary Protection Certificates for MYOVIEW 30ML

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for MYOVIEW 30ML

Last updated: July 28, 2025

Introduction

MYOVIEW 30ML, a radiopharmaceutical agent used primarily for cardiac imaging, is positioned within a niche but rapidly evolving segment of the diagnostic medical imaging market. Its development, approval, and commercialization are influenced by a convergence of clinical, regulatory, technological, and market factors. This analysis explores the current market landscape, anticipated demand drivers, competitive positioning, regulatory environment, and financial prospects associated with MYOVIEW 30ML.

Overview of MYOVIEW and Its Market Position

MYOVIEW, with the active ingredient technetium Tc 99m tetrofosmin, is a radiotracer employed in myocardial perfusion scintigraphy (MPS). It provides clinicians with detailed insights into coronary artery disease, facilitating diagnosis and management. The 30ML formulation refers to the volume of the radiopharmaceutical kit, which is relevant for manufacturing and distribution logistics.

Since its initial approval, MYOVIEW has held a significant share in nuclear cardiology imaging, competing chiefly with agents like Cardiolite (sestamibi) and others under the technetium-based radiotracers class. Its advantages include favorable imaging qualities, ease of distribution due to the technetium generator system, and established clinical efficacy.

Market Dynamics

Demand Drivers

The primary demand for MYOVIEW stems from the rising prevalence of cardiovascular diseases (CVDs). According to the World Health Organization (WHO), CVDs remain the leading cause of death globally, accounting for roughly 17.9 million fatalities annually [1]. As populations age, the incidence of coronary artery disease increases, sustaining demand for diagnostic imaging tools like MYOVIEW.

Furthermore, the expanding adoption of nuclear cardiology procedures driven by improved diagnostic accuracy and non-invasive nature enhances MYOVIEW’s market penetration. Advances in imaging technology, including hybrid modalities such as SPECT/CT, bolster clinical confidence and expand procedure volumes.

Market Expansion Factors

Technological innovation, such as the development of SPECT systems with higher sensitivity and resolution, augments the utility of radiotracers like MYOVIEW. Additionally, portable and automated manufacturing solutions reduce logistical constraints, enabling broader geographic reach—especially in emerging markets with increased healthcare infrastructure investments.

Regulatory and Reimbursement Environment

Regulatory approval landscapes significantly shape market access. Regulatory agencies such as the FDA and EMA have cleared MYOVIEW based on its safety and efficacy profiles. Reimbursement policies, influenced by national healthcare systems, impact procedure volume; favorable reimbursement encourages widespread utilization, while policy shifts or reimbursement cuts can suppress demand.

Competitive Landscape

MYOVIEW faces competition from other technetium-based agents like Cardiolite, as well as innovations in PET myocardial perfusion imaging (e.g., Rb-82 and 13N-ammonia). While PET offers higher resolution and quantitative capabilities, SPECT agents like MYOVIEW still dominate due to lower costs and wider availability.

Emerging competitors include novel radiotracers and multi-modality imaging agents, generating market pressure on MYOVIEW. However, the extensive clinical adoption history of MYOVIEW and established supply chains sustain its market position.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Historically, MYOVIEW revenues have demonstrated stable growth attributable to consistent cardiovascular disease prevalence and increasing procedural volumes. The drug benefits from a well-established manufacturing process, leading to relatively steady profit margins.

Forecasted Market Growth

The global nuclear cardiology market is projected to grow at a CAGR of approximately 4-6% through 2028 [2]. This growth is driven by increased testing, technological advancements, and expanding healthcare access in emerging markets.

Assuming MYOVIEW maintains or slightly gains market share, forecasted revenues should reflect the overall market expansion. For instance, if the current annual sales are approximately $150 million globally, a conservative 5% CAGR suggests revenues reaching circa $190 million by 2028.

Factors Influencing Financial Trajectory

• Market Penetration: A broader adoption driven by clinical guidelines endorsing nuclear cardiology could result in revenue increases.
• Geographic Expansion: Entry into emerging markets with growing healthcare infrastructure can significantly boost revenue streams.
• Regulatory Variants: Label expansions, such as approvals for new indications or formulations, open additional revenue channels.
• Pricing and Reimbursement: Favorable reimbursement policies sustain procedural volumes, whereas reimbursement declines might impede revenue growth.

Cost Aspects and Profit Margins

Manufacturing costs for MYOVIEW are relatively stable due to established production processes, but fluctuations in raw material prices, such as molybdenum-99 and technetium generators, could influence margins. Additionally, investments in advanced production facilities or licensing agreements impact cash flows.

Summary of Financial Outlook

The financial trajectory for MYOVIEW 30ML appears cautiously optimistic, aligned with the broader nuclear cardiology market outlook. Steady demand, incremental market share gains, and geographic expansion are key drivers. Investors and stakeholders should monitor regulatory developments and reimbursement policies that could accelerate or hinder growth.

Regulatory Landscape and Its Financial Impacts

Changes in regulatory policies, such as the European Union’s pharmacovigilance updates or the U.S. FDA’s evolving guidelines on nuclear imaging agents, influence clinical utilization and, consequently, sales. Additionally, the potential approval of generic or biosimilar versions could trigger price competition.

Market Risks and Challenges

• Increased competition from PET-based imaging agents with superior diagnostic properties.
• Reimbursement uncertainties in key markets.
• Supply chain disruptions for raw materials, impacting manufacturing costs.
• Technological shifts favoring alternative imaging modalities.

Conclusion

MYOVIEW 30ML maintains a strong foothold within the nuclear cardiology diagnostic segment. Its market dynamics depend on epidemiological trends, technological advances, regulatory policies, and competitive pressures. Financial prospects are favorable given the ongoing demand for cardiac imaging, with moderate growth expected contingent upon strategic market expansion and safeguarding reimbursement pathways.

---

Key Takeaways

• MYOVIEW’s primary demand correlates with the increasing global burden of cardiovascular diseases.
• Market growth is driven by technological improvements, expanding healthcare infrastructure, and procedural adoption.
• Stable manufacturing and established clinical use underpin consistent financial performance.
• Geographic expansion into emerging markets offers significant revenue potential.
• Regulatory and reimbursement landscape stability is critical to sustaining growth; shifts could alter the trajectory.

---

FAQs

1. What are the main clinical advantages of MYOVIEW over competing agents?
MYOVIEW offers high-quality imaging, reliable myocardial perfusion assessment, and established clinical validation. Its favorable pharmacokinetic profile enables clear visualization of cardiac tissue, facilitating accurate diagnosis.

2. How does the regulatory environment affect MYOVIEW’s market potential?
Regulatory approvals facilitate access in key markets. Stringent safety and efficacy requirements, clear labeling, and favorable reimbursement policies determine clinical adoption rates and revenue streams.

3. What impact do emerging imaging modalities have on MYOVIEW’s market share?
Advancements in PET imaging, which offers higher resolution, may gradually challenge SPECT agents like MYOVIEW. However, cost and infrastructure limitations currently favor continued use of technetium agents.

4. How can manufacturers mitigate supply chain risks associated with radioisotopes?
Investing in diversified supplier networks, maintaining buffer stocks, and adopting flexible manufacturing processes help address potential shortages in molybdenum-99 and other raw materials.

5. What future developments could significantly influence MYOVIEW’s financial trajectory?
Regulatory approvals for new indications, introduction of cheaper biosimilars, or technological breakthroughs in imaging could alter the competitive landscape and revenue outlook.

---

References

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs).
[2] MarketWatch. (2022). Nuclear cardiology market size and forecast.