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Last Updated: December 12, 2025

TECHNETIUM TC-99M PENTETATE KIT Drug Patent Profile


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Which patents cover Technetium Tc-99m Pentetate Kit, and what generic alternatives are available?

Technetium Tc-99m Pentetate Kit is a drug marketed by Curium and Ge Healthcare and is included in two NDAs.

The generic ingredient in TECHNETIUM TC-99M PENTETATE KIT is technetium tc-99m pentetate 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 pentetate kit profile page.

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Summary for TECHNETIUM TC-99M PENTETATE KIT
Drug patent expirations by year for TECHNETIUM TC-99M PENTETATE KIT
Pharmacology for TECHNETIUM TC-99M PENTETATE KIT
Drug ClassLead Chelator
Mechanism of ActionLead Chelating Activity

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Curium TECHNETIUM TC-99M PENTETATE KIT technetium tc-99m pentetate kit INJECTABLE;INJECTION 215146-001 Mar 26, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare TECHNETIUM TC-99M PENTETATE KIT technetium tc-99m pentetate kit INJECTABLE;INJECTION 017264-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Pentetate Kit

Last updated: July 30, 2025

Introduction

Technetium Tc-99m Pentetate Kit (commonly known by its trade names such as Diethylenetriaminepentaacetic acid (DTPA)) is a critical radiopharmaceutical used extensively in diagnostic imaging procedures, notably in cerebral ventriculography and renal function assessment. Its importance within nuclear medicine is underpinned by its radiochemical stability, high image resolution, low radiation dose, and favorable safety profile. Given its pivotal role, understanding the market dynamics and financial trajectory of Tc-99m Pentetate is vital for stakeholders across pharmaceutical manufacturing, healthcare providers, and investors.

Market Overview

The global nuclear medicine market is witnessing steady expansion, propelled by technological advancements, increasing prevalence of chronic diseases, and rising awareness of diagnostic imaging. Technetium-99m, accounting for over 80% of all nuclear medicine procedures, remains a cornerstone isotope due to its favorable physical properties and availability via generators [1].

Within this landscape, Tc-99m Pentetate kits serve as vital diagnostic agents. Their usage spans nephrology, neurology, and oncology diagnostics, with specific assays for cerebrospinal fluid and renal clearance. As such, the demand for Tc-99m Pentetate is intrinsically linked to the growth of nuclear medicine procedures globally.

Market Drivers

1. Rising Prevalence of Target Diseases and Diagnostic Procedures

The increasing incidence of kidney diseases, neurological disorders, and cancers fuels the demand for diagnostic imaging. Chronic kidney disease (CKD), in particular, reaches over 850 million cases globally [2], necessitating precise renal function assessments where Tc-99m Pentetate offers unparalleled accuracy.

2. Technological Advancements and Innovation

Improvements in radiopharmaceutical manufacturing, generator technology, and imaging techniques enhance diagnostic quality and safety. Automation in kit preparation reduces contamination risks, expedites patient throughput, and broadens accessibility.

3. Regulatory Approvals and Reimbursement Policies

Regulatory bodies such as the FDA and EMA have streamlined approval pathways for Tc-99m radiopharmaceuticals, fostering market expansion. Additionally, reimbursement policies in developed countries incentivize the use of nuclear imaging, further supporting sales.

4. Geographic Expansion

Emerging markets in Asia-Pacific, Latin America, and Africa are witnessing infrastructural development and increased healthcare spending. This expansion translates into rising demand for diagnostic agents, including Tc-99m Pentetate.

Market Challenges

1. Isotope Supply Constraints

Tc-99m production hinges on molybdenum-99 (Mo-99) generators. Supply shortages, caused by aging reactors and geopolitical issues, intermittently disrupt availability, impacting kit manufacturing and distribution.

2. Short Half-life Limiting Shelf-life

Tc-99m's half-life of 6 hours constrains the logistics chain. Effective distribution centers, timely synthesis, and rapid administration are crucial for maintaining efficacy.

3. Competition from Alternative Imaging Modalities

Emerging technologies such as PET imaging (with isotopes like F-18) and MRI challenge traditional nuclear medicine approaches, potentially affecting demand trajectories.

Financial Trajectory and Market Forecast

The global market for Tc-99m radiopharmaceuticals, including kits like Tc-99m Pentetate, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years (2023–2028), driven by global healthcare expansion and technological innovation [3].

Revenue Streams and Key Players

Major players, including Jubilant Radiopharma, Curium Pharmaceuticals, and Lantheus Holdings, command significant market shares through established manufacturing processes, strategic acquisitions, and extensive distribution networks. The revenue from Tc-99m kits contributes a significant portion of their nuclear medicine segment, often accounting for 20-30% of total sales.

Price Trends

Pricing remains relatively stable, influenced by manufacturing costs, isotope procurement, regulatory compliance, and competitive positioning. Innovations reducing production costs or improving shelf-life could further enhance profit margins.

Investment Considerations

Investors should monitor supply chain stability, regulatory landscape, and technological shifts. Companies with diversified portfolios in nuclear medicine and strong distribution channels are better positioned for sustainable growth.

Impact of Isotope Supply Chain Dynamics

The viability of Tc-99m Pentetate kits directly correlates with the stability of Mo-99 supply. Recent initiatives to diversify supply, including reactor refurbishments, alternative production methods (such as accelerator-based Mo-99 production), and international cooperation, aim to mitigate shortages [4].

These efforts are anticipated to stabilize isotope availability, reducing operational risks for kit manufacturers, and supporting consistent revenue streams.

Regulatory and Market Growth Opportunities

1. Expanded Indications and Diagnostic Protocols

Research initiatives exploring novel diagnostic applications of Tc-99m Pentetate — such as in recent advances in neurodegenerative disease assessment — could unlock new markets and revenue streams.

2. Enhanced Automation and Kit Formulation

Automation improves manufacturing efficiency, batch consistency, and patient safety. Regulatory approval of advanced kit formulations can diversify product offerings and enable premium pricing.

3. Market Penetration in Underdeveloped Regions

Infrastructure investments in healthcare systems across developing nations present lucrative opportunities for expanding the use of Tc-99m-based imaging agents.

Conclusion

Technetium Tc-99m Pentetate Kits occupy a resilient position within the nuclear medicine market, underpinned by their diagnostic accuracy, regulatory support, and the expanding scope of nuclear imaging. While current challenges such as isotope supply constraints exist, active industry initiatives and technological innovations are poised to sustain and enhance their market trajectory. Continued investments in supply chain stability, product innovation, and geographic expansion will be pivotal in optimizing the financial prospects of Tc-99m Pentetate kits.


Key Takeaways

  • The global nuclear medicine market's steady growth, driven by technological innovation and rising disease prevalence, supports the sustained demand for Tc-99m Pentetate kits.
  • Supply chain stability, particularly the availability of Mo-99, is critical to maintaining consistent market performance.
  • Regulatory environment and reimbursement policies in key markets significantly influence market expansion and profitability.
  • Emerging markets and technological advancements present opportunities for market share growth.
  • Strategic focus on innovation, automation, and geographic expansion will enhance financial trajectory and competitive positioning.

FAQs

1. What are the primary medical indications for Tc-99m Pentetate?
Tc-99m Pentetate is primarily used in renal function imaging (renal scintigraphy) and cerebrospinal fluid studies, aiding in diagnosis of kidney disorders, hydrocephalus, and neurological conditions.

2. How does isotope supply affect the market for Tc-99m kits?
Supply disruptions in Mo-99 generators can cause shortages of Tc-99m, impacting kit manufacturing and clinical availability, thereby affecting sales and revenue stability.

3. What technological innovations are poised to influence the Tc-99m Pentetate market?
Developments in kit automation, formulation stability, and alternative isotope production methods aim to improve logistics, safety, and cost-efficiency.

4. Which regions are emerging as significant markets for Tc-99m radiopharmaceuticals?
Asia-Pacific, Latin America, and parts of Africa are emerging markets due to healthcare infrastructure growth and increasing adoption of nuclear medicine diagnostics.

5. What strategic moves should companies make to capitalize on the growth of Tc-99m Pentetate?
Investing in supply chain diversification, regulatory compliance, innovation in kit formulations, and expanding distribution networks in underpenetrated markets are key strategies.


References

[1] Technetium-99m Radiopharmaceuticals Market – Growth, Trends, and Forecasts (2022-2027). MarketsandMarkets.

[2] Global Burden of Disease Study 2019. Lancet, 2020.

[3] Research and Markets. “Nuclear Medicine Radiopharmaceutical Market – Global Analysis and Forecast (2023-2028).”

[4] International Atomic Energy Agency (IAEA). “Status of Mo-99 Supply,” 2021.

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