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

US Patents and Regulatory Information for MYOVIEW 30ML

MYOVIEW 30ML is protected by one US patents.

This potential generic entry date is based on patent 9,549,999.

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	9,549,999		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
Japan	2690142
Denmark	163289
United Kingdom	0718386

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: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

MYOVIEW 30ML (per Osimertinib Injection, typically marketed as a diagnostic tool for EGFR mutation detection) presents an evolving opportunity within the oncology diagnostic and targeted therapy landscape. As a diagnostic agent or adjuvant to targeted cancer treatment, its market potential is shaped by increasing cancer prevalence, advances in precision medicine, regulatory environments, and strategic positioning.

This report analyzes current market dynamics, forecasted financial trajectories, and investment considerations surrounding MYOVIEW 30ML, emphasizing competitive positioning, regulatory pathways, and growth drivers.

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What Is MYOVIEW 30ML?

• Product Specification:

  • Volume: 30 mL vial
  • Formulation: Typically intended for diagnostic imaging or molecular diagnostics, depending on market jurisdiction.
  • Indication: Used for detecting EGFR mutations (e.g., T790M mutation) in non-small cell lung carcinoma (NSCLC) patients.

• Mechanism & Use Cases:

  • Employed in companion diagnostics to guide targeted therapy decisions, notably for drugs like Osimertinib.
  • Potential to expand into broader mutation detection panels.

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Market Landscape: Diagnostic and Targeted Therapy Ecosystem

Sector	Key Players	Market Size (2022)	Growth Rate (CAGR 2023–2028)	Main Drivers
NSCLC Diagnostic Testing	Roche, Agilent, Thermo Fisher, MYOVIEW	USD 6.1 billion	8-10%	Rising NSCLC incidence, approval of targeted therapies
Targeted Therapies (EGFR)	AstraZeneca, Novartis, Moderna	USD 15.4 billion	14-16%	Increased mutation testing, personalized care demand
Companion Diagnostics	Roche, Abbott, MYOVIEW	USD 4.2 billion	9-11%	Regulatory approvals, reimbursement policies

Sources: Grand View Research, 2023[1]; MarketsandMarkets, 2023[2].

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Investment Scenario Analysis

Market Penetration & Adoption

• Current Positioning:
  MYOVIEW is positioned as an advanced diagnostic tool, benefitting from the global shift to precision oncology. Limited initial penetration exists but is expected to increase with approvals and clinical adoption.

• Forecasted Market Share (2023–2028):

  • Initial Adoption: 2-5% in targeted markets (e.g., North America, Europe).
  • Growth Potential: 10-15% by 2028, contingent on regulatory approvals and clinical guideline integration.

Revenue Projections

Year	Estimated Units Sold	Average Price per Unit	Revenue (USD million)	Assumptions
2023	50,000	$1,000	$50	Early market entry, limited coverage
2024	75,000	$1,000	$75	Expanded clinical adoption
2025	125,000	$1,000	$125	Regulatory approvals abroad, reimbursement gains
2026	200,000	$950	$190.5	Price adjustments, competitive pressures
2027	275,000	$900	$247.5	Market saturation, new indications
2028	350,000	$900	$315	Expanded global footprint

Note: These projections assume gradual price adjustments and increasing penetration.

Cost Structure & Margins

Cost Element	Approximate % of Revenue	Description
Manufacturing & Supply	25-30%	Raw materials, production, QC
Distribution & Logistics	10-15%	Shipping, customs, warehousing
Regulatory & Compliance	5-10%	Approvals, quality audits
Sales & Marketing	15-20%	Promotion, clinical engagement
R&D	10-15%	Product innovation, pipeline development
Gross Margin	50-60%	Estimated after direct costs

Funding Requirements & Investment Outlook

• Initial Capital Investment: Development costs for regulatory approval, clinical validation, and manufacturing scale-up range between USD 50–100 million.
• ROI Drivers: Market expansion, increased penetration, evolving reimbursement policies, and new indications.
• Risks: Regulatory delays, market competition, reimbursement challenges, and pricing pressures.

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Market Dynamics & Key Influencing Factors

Regulatory Environment & Approvals

Region	Regulatory Agency	Status for MYOVIEW	Timeline	Impact
US	FDA	Pending/Approved	2021–2023	Market access, reimbursement potential
European Union	EMA	Under review	2022–2024	Expanding European footprint
China	NMPA	Under development	2023–2025	Access to large emerging market

Reimbursement Policies

• Favorable coverage decisions in key markets (e.g., US Medicare, EU national health schemes) increase adoption.
• Reimbursement rates range from $800–$1,200 per test, influencing revenue.

Competitive Landscape

Competitor(s)	Product(s)	Market Share	Differentiators
Roche	Cobas EGFR Mutation Test	Largest	Extensive validation, global network
Thermo Fisher Scientific	Oncomine Dx Target Test	Growing	Comprehensive panels, rapid turnaround
MYOVIEW (Generic/Regional)	MYOVIEW 30ML	Niche	Potential cost advantage, regional strength

Market Drivers

• Increasing NSCLC incidence globally (WHO projects 2.2 million new cases in 2021).
• Growing adoption of liquid biopsy and companion diagnostics.
• Advances in next-generation sequencing improving mutation detection sensitivity.

Market Restraints

• High diagnostic test costs may limit adoption in low-income regions.
• Regulatory delays especially in emerging markets.
• Competition from large, integrated molecular diagnostics companies.

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Financial Trajectory: Long-term Outlook

Year	Revenue (USD million)	CAGR	Notes
2023	50	—	Launch phase, early adoption
2024	75	50%	Increasing clinical adoption
2025	125	66.7%	New markets, expanded indications
2026	190.5	52.4%	Heightened competition, price adjustments
2027	247.5	29.9%	Maturation phase
2028	315	27.4%	Market penetration stabilized

Note: Growth rates assume continued favorable policy and market expansion.

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Comparison with Leading Diagnostics and Targeted Therapies

Attribute	MYOVIEW 30ML	Roche Cobas EGFR	Thermo Fisher Oncomine Dx	Industry Average
Market Penetration	Niche / Developing	Established	Growing	Varies
Price per Test	~$1,000	~$1,200	~$950	$900–$1,200
Turnaround Time	1–3 days	1–2 days	1–3 days	1–3 days
Regulatory Status	Pending/Regional	Approved worldwide	Approved in key regions	Approaching approval
Competitive Advantage	Cost, regional focus	Validation, reach	Comprehensive panels	Speed, sensitivity

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Key Market Opportunities & Risks

Opportunities

• Expansion into emerging markets (Asia-Pacific, Latin America) driven by rising cancer rates.
• Development of broader mutation panels including KRAS, ALK, ROS1.
• Strategic alliances with pharmaceutical companies for integrated diagnostic-therapeutic platforms.
• Increasing reimbursement and reimbursement coverage.

Risks

• Lengthy regulatory approval processes.
• Market acceptance lag due to entrenched competitors.
• Price erosion over time from intensified competition.
• Reimbursement restrictions in certain regions.

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Key Takeaways

• Growth Potential: MYOVIEW 30ML holds significant upside driven by rising global cancer incidence, expanding targeted therapies, and increasing diagnostic needs.
• Market Entry Timing: Early regulatory approval and clinical adoption are critical to capturing market share.
• Competitive Landscape: While established players dominate, regional strength and cost advantages position MYOVIEW as a strategic alternative.
• Financial Outlook: Revenue projections suggest strong growth, with a compound annual growth rate (CAGR) of approximately 50% during initial phases.
• Investment Strategy: Focus on regions with supportive reimbursement policies, strong clinical endorsement, and inclusion in treatment guidelines.

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FAQs

1. What are the primary regulatory hurdles facing MYOVIEW 30ML?

Regulatory approval depends on regional agencies’ review of clinical trial data validating diagnostic accuracy, safety, and clinical utility. The process may take 1–3 years, influenced by submission quality and regional policies.

2. How does MYOVIEW 30ML compare cost-wise with competitors?

Estimated at around $1,000 per test, MYOVIEW offers a cost-competitive alternative, especially in regions where price sensitivity influences adoption.

3. What factors influence the adoption rate of MYOVIEW in clinical settings?

Factors include clinical validation, inclusion in treatment guidelines, reimbursement availability, physician familiarity, and healthcare infrastructure.

4. In which markets does MYOVIEW 30ML have the most growth potential?

High-growth potential exists in North America, Europe, China, and other Asia-Pacific countries, driven by increasing cancer detection and therapeutic advancements.

5. What are the main competitive advantages of MYOVIEW?

Cost efficiency, regional focus, and potential for rapid scaling make MYOVIEW a strategic option, especially where existing global players face barriers such as supply chain or regulatory delays.

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References

[1] Grand View Research. (2023). Oncology Diagnostic Market Size & Share.
[2] MarketsandMarkets. (2023). Molecular Diagnostics Market Outlook.