MYOVIEW 30ML Drug Patent Profile

When do Myoview 30ml patents expire, and what generic alternatives are available?

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
Spain	2082771
United Kingdom	0718386
China	1079746
Japan	5764328

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

Myoview 30ml Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Myoview 30ml, a radiopharmaceutical contrast agent for myocardial perfusion imaging, faces a market shaped by evolving diagnostic standards, competition from alternative imaging modalities, and patent expiry timelines. Its financial trajectory is intrinsically linked to its market penetration, pricing strategies, and the R&D investment in its lifecycle management.

What is Myoview 30ml and Its Clinical Application?

Myoview 30ml is a technetium-Tc-99m sestamibi injectable solution. It is indicated for use in myocardial perfusion imaging to evaluate patients with suspected or known coronary artery disease. The agent allows for the assessment of blood flow to the heart muscle, aiding in the diagnosis of myocardial infarction and ischemia.

The administration involves intravenous injection, followed by imaging with a gamma camera to detect the distribution of the radioisotope within the heart. This diagnostic information is crucial for risk stratification and guiding therapeutic decisions in cardiology.

What are the Key Market Drivers for Myoview 30ml?

The market for Myoview 30ml is influenced by several key drivers:

• Prevalence of Cardiovascular Disease: The persistent and increasing global burden of cardiovascular diseases, including coronary artery disease, directly fuels demand for diagnostic tools like myocardial perfusion imaging. According to the World Health Organization, cardiovascular diseases remain the leading cause of death globally, accounting for an estimated 17.9 million deaths annually [1].
• Diagnostic Imaging Guidelines: Inclusion and emphasis within established clinical practice guidelines for the diagnosis and management of coronary artery disease support the sustained use of myocardial perfusion imaging. Organizations such as the American College of Cardiology (ACC) and the European Society of Cardiology (ESC) provide recommendations that often feature this diagnostic modality.
• Aging Population: An increasing global geriatric population is associated with a higher incidence of cardiovascular conditions, thereby expanding the patient pool requiring diagnostic assessments. The United Nations projects that the number of people aged 65 and over will increase from 703 million in 2019 to 1.5 billion in 2050 [2].
• Technological Advancements in Imaging Equipment: Improvements in gamma camera technology, including higher resolution and faster acquisition times, enhance the diagnostic accuracy and efficiency of myocardial perfusion imaging, indirectly supporting demand for agents like Myoview.

What are the Key Market Restraints for Myoview 30ml?

Several factors act as restraints on the market growth and revenue generation for Myoview 30ml:

• Competition from Alternative Imaging Modalities: Myoview faces competition from other diagnostic imaging techniques.
  • Echocardiography: Stress echocardiography, particularly dobutamine stress echocardiography, is a widely used alternative for assessing myocardial function and perfusion, often without the use of ionizing radiation.
  • Cardiac Magnetic Resonance Imaging (CMR): CMR offers superior soft tissue contrast and functional assessment capabilities, with stress CMR emerging as a powerful tool for evaluating myocardial ischemia. While often more expensive, its diagnostic yield is increasing.
  • Coronary Computed Tomography Angiography (CCTA): CCTA provides detailed anatomical information about coronary arteries and can also infer functional significance in some cases. Its use is growing for ruling out coronary artery disease in select patient populations.
• Radiation Exposure Concerns: As a radiopharmaceutical, Myoview involves exposure to ionizing radiation, which can be a deterrent for both physicians and patients, especially in the context of repeated imaging or when alternative non-ionizing modalities are available.
• Reimbursement Landscape: Changes in reimbursement policies by government and private payers can significantly impact the adoption and utilization of myocardial perfusion imaging, potentially limiting access to Myoview.
• Cost-Effectiveness Considerations: The overall cost of performing a myocardial perfusion imaging study, including the radiopharmaceutical, equipment, and personnel, is a factor in clinical decision-making, particularly in resource-constrained healthcare systems.

What is the Intellectual Property Landscape for Myoview 30ml?

The intellectual property surrounding Myoview 30ml is critical to its market exclusivity and pricing power.

• Primary Patents: The original patents covering the composition of matter and methods of use for technetium-99m sestamibi have long since expired. These foundational patents were essential for the initial market entry and establishment of the product.
• Formulation and Manufacturing Patents: Pharmaceutical companies often seek to extend market exclusivity through patents covering specific formulations, manufacturing processes, or improved delivery methods. Analyzing the patent portfolio of the primary manufacturer (GE HealthCare, formerly Bracco Diagnostics) and potential generic manufacturers is crucial.
• Patent Expiry Dates: The primary patent expiry dates for the core technology of Tc-99m sestamibi have passed. This opens the door for generic competition.
• Generic Competition: The entry of generic versions of Tc-99m sestamibi, if available and approved by regulatory bodies, would significantly impact the market share and pricing of branded Myoview. Generic products typically enter the market at a substantially lower price point.
• Regulatory Exclusivity: Beyond patent protection, regulatory exclusivity periods granted by agencies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) can provide additional market protection. However, for older molecules like Tc-99m sestamibi, these periods are generally not a significant factor for sustained exclusivity.

What is the Competitive Landscape for Myoview 30ml?

The competitive landscape for Myoview 30ml is characterized by the presence of other radiopharmaceuticals and the aforementioned alternative imaging modalities.

• Direct Competitors (Radiopharmaceuticals):
  • Technetium-99m Tetrofosmin (e.g., Myolight): Another technetium-99m based myocardial perfusion agent that competes directly with sestamibi. It shares similar pharmacokinetic and diagnostic properties.
  • Thallium-201: An older radiopharmaceutical for myocardial perfusion imaging. While less commonly used than Tc-99m agents due to lower energy and longer imaging times, it still holds a niche in specific clinical scenarios.
• Indirect Competitors (Non-Radiopharmaceuticals):
  • Stress Echocardiography
  • Cardiac Magnetic Resonance Imaging (CMR)
  • Coronary Computed Tomography Angiography (CCTA)
  • Fractional Flow Reserve (FFR) – While an invasive physiological assessment, it competes for the diagnostic pathway for intermediate lesions.

The market share of Myoview is influenced by physician preference, historical usage patterns, cost, availability, and the specific diagnostic questions being addressed.

What is the Financial Trajectory and Revenue Generation for Myoview 30ml?

The financial trajectory of Myoview 30ml is a function of its market position, pricing, sales volume, and the timing of generic entry.

• Historical Sales Performance: Historically, Myoview has been a significant product in the myocardial perfusion imaging market. Its revenue generation would have peaked during its patent-protected period.
• Current Revenue: Current revenue is likely influenced by the volume of procedures performed using Tc-99m sestamibi, its pricing, and the extent of generic competition. As patents have expired, pricing pressures from generic alternatives or lower-cost alternatives would be expected.
• Pricing Strategy: Branded Myoview typically commands a premium price. However, post-patent expiry, manufacturers may need to adjust pricing to remain competitive against generics or adopt market segmentation strategies.
• Sales Volume: Sales volume is directly correlated with the number of myocardial perfusion imaging procedures performed globally. This, in turn, is affected by guideline recommendations, competitive modality adoption, and healthcare economics.
• Generic Impact: The entry and market penetration of generic Tc-99m sestamibi agents will lead to a significant decline in the average selling price (ASP) of the product. Revenue for the branded product will be compressed, with the overall market volume potentially increasing due to lower costs.
• Lifecycle Management: Manufacturers may attempt to extend the financial life of Myoview through strategies such as developing new formulations, combination therapies, or focusing on specific patient populations where its value proposition remains strong. However, for older radiopharmaceuticals, such strategies are often limited.
• Projected Revenue: Projections would likely show a decline in revenue for branded Myoview due to generic erosion, potentially offset by increased overall procedural volumes at lower ASPs for the radiopharmaceutical class.

What is the Market Size and Growth Potential for Myoview 30ml?

Estimating the precise market size for Myoview 30ml as a single product is challenging due to proprietary sales data. However, the broader market for myocardial perfusion imaging agents provides context.

• Global Market for Myocardial Perfusion Imaging Agents: This market is estimated to be in the hundreds of millions of dollars annually. While specific figures for Tc-99m sestamibi alone are not publicly disclosed, it represents a significant segment.
• Growth Rate: The growth rate for myocardial perfusion imaging agents is likely to be modest, driven by the increasing prevalence of CVD and aging populations, but constrained by the rise of alternative imaging technologies and the availability of lower-cost generics. Projected growth might range from 1-3% annually.
• Regional Variations: Market size and growth will vary by region, influenced by healthcare infrastructure, reimbursement policies, and the adoption rates of new technologies. Developed markets in North America and Europe may see slower growth due to established competition, while emerging markets could offer higher growth potential.
• Impact of Generic Entry on Market Value: The entry of generics will decrease the overall dollar value of the branded Myoview market but may increase the volume of sestamibi used if price reductions encourage more procedures. The overall market value for Tc-99m sestamibi as a class will likely plateau or decline due to price erosion.

Key Takeaways

Myoview 30ml operates in a mature diagnostic imaging market. Its future financial performance is characterized by declining revenues for the branded product due to patent expiries and increasing generic competition. While the underlying demand for myocardial perfusion imaging is supported by cardiovascular disease prevalence and an aging population, growth is tempered by the availability of alternative imaging modalities and reimbursement pressures. Strategic pricing adjustments and lifecycle management efforts by the manufacturer are critical to navigating this evolving landscape.

Frequently Asked Questions

1. What is the primary indication for Myoview 30ml? Myoview 30ml is indicated for myocardial perfusion imaging to assess blood flow to the heart muscle in patients with suspected or known coronary artery disease.
2. When did the main patents for Myoview 30ml expire? The foundational patents covering the composition of matter and primary methods of use for technetium-99m sestamibi have expired.
3. How does Myoview 30ml compare to cardiac MRI for diagnosing coronary artery disease? Cardiac MRI offers higher spatial resolution and avoids ionizing radiation, providing detailed functional and structural information. Myoview utilizes ionizing radiation but is often more widely accessible and can be more cost-effective in certain settings.
4. What is the impact of generic Tc-99m sestamibi on the Myoview 30ml market? Generic Tc-99m sestamibi will lead to significant price erosion for the branded Myoview, reducing its revenue and market share.
5. Are there any new clinical applications being explored for Myoview 30ml? While Myoview is established for its primary indication, significant new clinical application development for older radiopharmaceuticals like Tc-99m sestamibi is uncommon, with a greater focus on lifecycle management and cost optimization in existing uses.

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Citations

[1] World Health Organization. (2021). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) [2] United Nations, Department of Economic and Social Affairs, Population Division. (2019). World Population Prospects 2019: Highlights. Retrieved from https://population.un.org/wpp/Publications/Files/WPP2019_Highlights.pdf