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Last Updated: March 26, 2026

Pentetate calcium trisodium yb-169 - Generic Drug Details


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What are the generic drug sources for pentetate calcium trisodium yb-169 and what is the scope of patent protection?

Pentetate calcium trisodium yb-169 is the generic ingredient in one branded drug marketed by 3M and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for pentetate calcium trisodium yb-169
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
DailyMed Link:pentetate calcium trisodium yb-169 at DailyMed
Recent Clinical Trials for pentetate calcium trisodium yb-169

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National Cancer Institute (NCI)Phase 1/Phase 2

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US Patents and Regulatory Information for pentetate calcium trisodium yb-169

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m YTTERBIUM YB 169 DTPA pentetate calcium trisodium yb-169 INJECTABLE;INJECTION 017518-001 Approved Prior to Jan 1, 1982 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

Pentetate calcium trisodium yb-169 Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Pentetate Calcium Trisodium Yb-169?

Pentetate calcium trisodium Yb-169 is a radiopharmaceutical agent used primarily in diagnostic imaging involving nuclear medicine procedures, particularly for detecting and locating tumors via radioisotope localization. Its application is niche compared to mainstream drugs, which influences market size and growth potential.

Market Size and Penetration

  • The global radiopharmaceuticals market was valued at approximately $6.3 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of around 4.8% through 2028 [1].
  • Yb-169 accounts for a small fraction of this revenue, estimated at less than 1%, due to its limited therapeutic application and narrow niche in diagnostic imaging.
  • Use of Yb-169 is primarily confined to specialized nuclear medicine centers, limiting broader market penetration.

Drivers and Barriers

  • Drivers:

    • Growing demand for precision diagnostics in oncology.
    • Advances in nuclear medicine imaging techniques increasing the need for specialized radiotracers.
    • Rising prevalence of cancers requiring diagnostic imaging.
  • Barriers:

    • Limited therapeutic applications restrict market growth.
    • Complexity of manufacturing and handling, requiring specialized facilities.
    • Regulatory hurdles due to radiopharmaceuticals' radioactive nature.

Competitive Landscape

  • Yb-169 operates in a segment with few direct competitors. Most radiopharmaceuticals used in similar applications include Tc-99m derivatives, which dominate due to wider availability and longer track records.
  • Companies like Nordion (canadian supplier) and vendors in the U.S. play significant roles, but market share data remains proprietary.
  • Few generic manufacturers produce Yb-169, limiting price competition.

Policy and Reimbursement Environment

  • Regulatory bodies (FDA, EMA) impose strict standards for radiopharmaceuticals, affecting approval timelines and market entry.
  • Reimbursement policies favor well-established, widely used diagnostic agents, posing challenges for niche drugs like Yb-169.
  • Recent expansions in nuclear medicine reimbursement codes could improve market access.

What Is the Financial Trajectory for Yb-169?

Revenue Trends

  • Due to limited production and niche application, Yb-169’s annual revenue globally is estimated below $50 million.
  • No public company reports specifically break out Yb-169 sales, but overall radiopharmaceuticals generate annual sales in the hundreds of millions.

Development and Manufacturing Costs

  • High costs relate to isotope production, especially with Yb-169’s specific neutron activation processes.
  • Manufacturing demands compliance with Good Manufacturing Practice (GMP), increasing operational expenses.

Pricing

  • Unit price estimates range from $200 to $500 per dose, depending on procurement volume and market region.
  • Price sensitivity exists because of the need for multiple doses per patient in certain procedures.

Future Revenue Potential

  • Market expansion depends on technological advancements that increase diagnostic accuracy and reduce costs.
  • Potential growth avenues include newer isotopes with longer half-lives or improved imaging qualities.
  • Regulatory and clinical validation may facilitate broader application—though Yb-169's niche status limits large-scale commercialization.

Investment and R&D Outlook

  • Investment in radiopharmaceutical manufacturing infrastructure and partnerships could expand production capacity.
  • Innovative derivatives or conjugates could extend Yb-169’s use beyond current diagnostics.

Summary

Yb-169’s market remains small, constrained by its specialized application and manufacturing challenges. Revenue growth prospects depend on technological advances in nuclear medicine, regulatory pathways, and clinical evidence supporting its diagnostic utility. Large-scale market expansion appears unlikely unless new indications or formulations emerge.

Key Takeaways

  • The global radiopharmaceutical market is growing, but Yb-169 accounts for a small segment focused on niche diagnostic procedures.
  • The drug's revenue potential is limited by its specialized application and manufacturing complexity.
  • Pricing is influenced by procurement volume and regional reimbursement policies.
  • Development efforts should focus on improving manufacturing efficiency and exploring new clinical indications.
  • Market growth hinges on technological advancements and regulatory developments.

FAQs

1. What are the main clinical uses of Yb-169?
Yb-169 is primarily used in diagnostic imaging within nuclear medicine, especially for tumor localization and evaluating cancer spread.

2. How does Yb-169 compare to other radiotracers?
Yb-169 has a narrow clinical scope compared to more widely used radiotracers like Tc-99m, limiting its market adoption.

3. What are the challenges in manufacturing Yb-169?
The isotope requires specialized neutron activation facilities, strict handling protocols due to radioactivity, and compliance with GMP standards.

4. Are there any new developments that could impact Yb-169's market?
Potential advancements include novel imaging techniques, conjugate development with therapeutic agents, or alternative isotopes with similar properties.

5. Which regions show the highest demand for Yb-169?
Demand is concentrated mainly in North America and Europe, where nuclear medicine infrastructure is advanced.

Citations

[1] Grand View Research, "Radiopharmaceuticals Market Size, Share & Trends Analysis Report," 2022.

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