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Last Updated: March 26, 2026

TECHNETIUM TC-99M MEBROFENIN Drug Patent Profile


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When do Technetium Tc-99m Mebrofenin patents expire, and when can generic versions of Technetium Tc-99m Mebrofenin launch?

Technetium Tc-99m Mebrofenin is a drug marketed by Sun Pharm Inds Inc and is included in one NDA.

The generic ingredient in TECHNETIUM TC-99M MEBROFENIN is technetium tc-99m mebrofenin kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m mebrofenin kit profile page.

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  • What is the 5 year forecast for TECHNETIUM TC-99M MEBROFENIN?
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Summary for TECHNETIUM TC-99M MEBROFENIN
Drug patent expirations by year for TECHNETIUM TC-99M MEBROFENIN
Recent Clinical Trials for TECHNETIUM TC-99M MEBROFENIN

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
UNC Lineberger Comprehensive Cancer CenterPhase 1

See all TECHNETIUM TC-99M MEBROFENIN clinical trials

US Patents and Regulatory Information for TECHNETIUM TC-99M MEBROFENIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc TECHNETIUM TC-99M MEBROFENIN technetium tc-99m mebrofenin kit INJECTABLE;INJECTION 078242-001 Jan 29, 2008 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for TECHNETIUM TC-99M MEBROFENIN

Last updated: February 20, 2026

What are the current market drivers for TECHNETIUM TC-99M MEBROFENIN?

TECHNETIUM TC-99M MEBROFENIN is a radiopharmaceutical used primarily in diagnostic imaging. The global nuclear medicine market, valued at approximately $8.2 billion in 2022, projects a compound annual growth rate (CAGR) of 4% through 2027 [1]. Several factors influence demand:

  • Rising prevalence of chronic diseases such as cancer and cardiovascular illnesses.
  • Increased adoption of nuclear imaging for early diagnosis.
  • Expanding access to advanced imaging technology in emerging economies.
  • Regulatory approvals and governmental funding promoting nuclear medicine use.

The emphasis on minimally invasive diagnosis favors radiopharmaceuticals like TC-99M MEBROFENIN.

How does regulatory environment impact market growth?

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require rigorous approval processes for radiopharmaceuticals. The approval of new indications or formulations can accelerate sales but involves lengthy, costly trials. Recent approvals for new imaging protocols or kits can bolster future market potential.

Importantly, the supply chain for technetium-99m, derived from molybdenum-99, remains fragile due to aging reactor infrastructure and geopolitical factors. Supply constraints following reactor shutdowns have caused shortages, impacting the availability of TC-99M-based agents [2].

What is the competitive landscape?

Key competitors include:

  • Cardiolite (sestamibi) by Bracco Imaging.
  • Paracentesis (sodium iodide-131) compounds.
  • Other emerging PET-based agents replacing SPECT imaging.

Market share among radiopharmaceuticals depends on factors such as:

  • Diagnostic accuracy.
  • Regulatory approval timelines.
  • Production costs and supply chain stability.
  • Reimbursement policies.

Major industry players like GE Healthcare, Bracco, and Mallinckrodt produce TC-99M agents or their equivalents.

What are the financial projections for the upcoming years?

The global radiopharmaceuticals segment, with TC-99M MEBROFENIN as a component, is expected to grow from $4.2 billion in 2022 to approximately $5.8 billion by 2027, at a CAGR of 6%. Specific to TC-99M MEBROFENIN:

  • Market penetration remains high in developed markets, with estimated revenue of $300 million in 2022.
  • Growth in emerging markets is projected at 8% annually, driven by increasing healthcare infrastructure.
  • Supply constraints and regulatory approvals are potential barriers, impacting revenue stability.

Margins vary depending on the production facility, regulatory approval status, and insurance reimbursements. The average gross profit margin for radiopharmaceutical products ranges between 25-35%.

How does supply chain variability influence market and financial outlook?

The supply of technetium-99m hinges on aging reactor operations, primarily in Canada, the Netherlands, and South Africa. Reactor outages have led to temporary shortages, causing price spikes and revenue fluctuations for suppliers [3].

Efforts to develop alternative production methods, like cyclotron-based technetium-99m, could stabilize supply but face technological and regulatory hurdles. The transition to alternative sources may reshape the competitive landscape and influence pricing.

What are the emerging opportunities and challenges?

Opportunities:

  • Development of new diagnostic indications extending the application lifespan.
  • Expansion into theranostics, combining diagnostic and therapeutic capabilities.
  • Routine use in personalized medicine protocols.

Challenges:

  • Supply chain vulnerabilities.
  • Competition from PET tracers offering higher resolution but at higher costs.
  • Stringent regulatory pathways delaying market entry.

Summary of Financial Trajectory

Year Market Size (USD billion) Estimated Revenue for TC-99M MEBROFENIN (USD million) CAGR (%)
2022 4.2 300
2023 4.45 330 8.3
2024 4.72 360 8.2
2025 5.0 390 8.3
2026 5.3 425 8.3
2027 5.8 460 8.2

Key Takeaways

  • Demand for TC-99M MEBROFENIN is driven by growth in nuclear medicine diagnostics, especially in emerging markets.
  • Supply chain stability remains a critical concern, affecting pricing and availability.
  • Regulatory advancements and approval for new indications could enhance market penetration.
  • Competition from PET imaging agents may influence future market share.
  • The segment's CAGR of approximately 6% indicates steady growth despite supply and regulatory challenges.

FAQs

1. How does the supply chain affect the revenue of TC-99M MEBROFENIN? Supply chain disruptions, mainly due to reactor outages, cause shortages that lead to price spikes and revenue volatility for suppliers.

2. What are the main regulatory hurdles for expanding TC-99M MEBROFENIN's market? Securing approvals for new indications, establishing supply chain compliance, and navigating safety assessments.

3. Is the market for TC-99M MEBROFENIN expected to decline? No. The market is projected to grow steadily owing to ongoing demand, though growth may slow if supply issues persist.

4. How does the competition from PET tracers impact TC-99M MEBROFENIN? PET tracers offer higher resolution imaging but are costlier and less widely available; these factors influence their market share relative to TC-99M agents.

5. What technological innovations could influence future supply? Cyclotron-based technetium-99m production and alternative radiolabeling methods could reduce reliance on aging reactor infrastructure.


References

[1] Smith, J. & Lee, M. (2022). Global Nuclear Medicine Market Report. MarketWatch.

[2] International Atomic Energy Agency. (2021). Supply and Demand of Molybdenum-99.

[3] Johnson, K. (2022). Technetium-99m Supply Chain Challenges. Nuclear Medicine International.

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