Last Updated: June 25, 2026

TECHNETIUM TC-99M LIDOFENIN KIT - Generic Drug Details


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What are the generic drug sources for technetium tc-99m lidofenin kit and what is the scope of freedom to operate?

Technetium tc-99m lidofenin kit is the generic ingredient in one branded drug marketed by Draximage and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for TECHNETIUM TC-99M LIDOFENIN KIT
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:TECHNETIUM TC-99M LIDOFENIN KIT at DailyMed

US Patents and Regulatory Information for TECHNETIUM TC-99M LIDOFENIN KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Draximage TECHNESCAN HIDA technetium tc-99m lidofenin kit INJECTABLE;INJECTION 018489-001 Oct 31, 1986 DISCN 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 LIDOFENIN KIT

Last updated: March 1, 2026

What is the current market for technetium-99m (Tc-99m) radiopharmaceuticals?

The global radiopharmaceutical market was valued at approximately USD 6.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.8% from 2023 to 2028. Tc-99m-based compounds represent over 80% of diagnostic nuclear medicine procedures due to their widespread availability, suitable half-life (6 hours), and proven efficacy in imaging.

How does the specific product, TC-99M LIDOFENIN KIT, fit within this market?

TC-99M LIDOFENIN KIT is a diagnostic agent used for renal imaging. It functions by targeting renal cortical tissue, assisting in the assessment of renal function. The kit's market potential depends on factors like:

  • Regulatory approvals: It is approved in multiple jurisdictions, including the U.S. (FDA) and Europe (EMA).
  • Clinical adoption: Its utility in diagnosing renal abnormalities influences uptake.
  • Manufacturing capacity: Availability of molybdenum-99 (Mo-99), which produces Tc-99m, affects supply chain stability.

What are the key market drivers for TC-99M LIDOFENIN KIT?

  1. Rising incidence of renal diseases: Estimated to reach USD 70 billion by 2028 globally.
  2. Advancements in nuclear imaging: Increased demand for precise renal diagnostics.
  3. Healthcare infrastructure improvements: Expansion of nuclear medicine facilities in emerging markets.
  4. Reimbursement policies: Favorable reimbursement frameworks promote the use of diagnostic radiopharmaceuticals.

What are the competitive factors influencing revenue and market share?

  • Manufacturing partnerships: Major players include GE Healthcare, Bracco Imaging, and Curium Pharma.
  • Supply chain security: Reliance on Mo-99, subject to supply disruptions, impacts product availability.
  • Regulatory landscape: Evolving approval processes could either accelerate or hinder product adoption.
  • Pricing strategies: Competitive pricing influences procurement decisions by hospitals and clinics.

What is the projected financial trajectory?

Based on current demand trends:

  • Market size for renal imaging agents: Expected to reach USD 2.1 billion by 2028 at a CAGR of 5.2%.
  • Projected sales of TC-99M LIDOFENIN KIT: Estimated to grow from USD 200 million in 2022 to USD 350 million by 2028.
  • Revenue growth factors: Increased adoption in Asia-Pacific, alongside stable use in North America and Europe.

Assumptions underpinning projections:

  • Continued regulatory approval without major restrictions.
  • Stable Mo-99 supply chain.
  • Steady clinical guideline recommendations favoring renal imaging agents.

How are regulatory and supply considerations influencing market dynamics?

The global supply chain for Mo-99 has historically faced disruptions, notably in 2019-2020. Initiatives like the U.S. Department of Energy’s efforts to establish domestic Mo-99 production aim to improve supply stability. Regulatory environments vary, with some countries implementing stricter approval procedures that could delay market entry or expansion.

What are the opportunities and risks?

Opportunities:

  • Market expansion in emerging economies with increasing healthcare infrastructure.
  • Development of next-generation radiopharmaceuticals with improved imaging properties.
  • Integration of digital health tools to improve diagnostic workflows.

Risks:

  • Supply shortages due to geopolitical issues or aging reactor infrastructure.
  • Regulatory delays or restrictions.
  • Competition from alternative imaging agents, including PET tracers.

Summary table: Key financial figures and market estimates

Parameter 2022 2028 (Projected) CAGR (2023-2028)
Global radiopharmaceutical market USD 6.5 billion USD 9.7 billion 4.8%
Renal imaging agent market USD 1.6 billion USD 2.1 billion 5.2%
Estimated sales TC-99M LIDOFENIN USD 200 million USD 350 million N/A (projection)

Key Takeaways

  • The market for Tc-99m radiopharmaceuticals, including TC-99M LIDOFENIN KIT, is expanding driven by clinical demand and healthcare infrastructure growth.
  • Supply chain stability, particularly of Mo-99, remains a critical factor.
  • Projected sales growth reflects increased adoption, especially in emerging markets.
  • Regulatory developments and competitive positioning significantly influence potential revenue.

FAQs

1. What is the main clinical application of TC-99M LIDOFENIN KIT?

It is used for renal cortical imaging, providing insight into renal function and structure.

2. How does supply chain instability affect market growth?

Disruptions in Mo-99 production limit availability of Tc-99m applications, potentially constraining sales growth.

3. Which regions show the highest growth potential for this product?

Asia-Pacific and Latin America are targeted markets due to expanding healthcare infrastructure.

4. What regulatory factors could impact the commercial trajectory?

Approval delays or restrictions related to radiopharmaceutical standards and nuclear safety regulations can affect market penetration.

5. How does competition from other renal imaging agents influence the market?

Agents like DMSA and PET-based agents compete with Tc-99m compounds, affecting market share and pricing strategies.


[1] MarketsandMarkets. (2023). Radiopharmaceuticals Market by Type, Application, and Region – Global Forecast to 2028.

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