SODIUM CHROMATE CR-51 - Generic Drug Details

What are the generic drug sources for sodium chromate cr-51 and what is the scope of freedom to operate?

Sodium chromate cr-51 is the generic ingredient in two branded drugs marketed by Bracco and Curium, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for SODIUM CHROMATE CR-51

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	7
DailyMed Link:	SODIUM CHROMATE CR-51 at DailyMed

US Patents and Regulatory Information for SODIUM CHROMATE CR-51

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	SODIUM CHROMATE CR 51	sodium chromate cr-51	INJECTABLE;INJECTION	016708-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bracco	CHROMITOPE SODIUM	sodium chromate cr-51	INJECTABLE;INJECTION	013993-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bracco	CHROMITOPE SODIUM	sodium chromate cr-51	INJECTABLE;INJECTION	013993-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Sodium Chromate Cr-51: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Sodium chromate Cr-51 (CAS No. 10170-71-1) is a radioisotope used primarily for diagnostic medical imaging and select therapeutic applications. Its market is characterized by a niche demand driven by its radioactive properties, leading to specific manufacturing and handling requirements. The financial trajectory is influenced by the steady but limited use in healthcare, coupled with the costs associated with radioisotope production and regulatory compliance.

Market Size and Key Applications

The global market for sodium chromate Cr-51 is a segment within the broader radiopharmaceutical industry. Precise market sizing is challenging due to the specialized nature of its production and limited public reporting by most manufacturers. However, estimates place the annual global market value in the low tens of millions of U.S. dollars.

Diagnostic Imaging

The primary application of sodium chromate Cr-51 is in diagnostic nuclear medicine. It is utilized in tests to assess organ function, particularly the red blood cell mass and survival studies [1]. This involves injecting a small dose of the radioisotope, which binds to red blood cells, allowing physicians to track their lifespan and distribution within the body. This is crucial for diagnosing and monitoring conditions such as:

• Anemia: Determining if anemia is caused by red blood cell destruction (hemolytic anemia) or impaired production.
• Splenic Sequestration: Identifying if red blood cells are being prematurely destroyed in the spleen.
• Gastrointestinal Bleeding: Locating sources of occult gastrointestinal bleeding by tracking red blood cells.

Therapeutic Applications

While less common than diagnostic uses, sodium chromate Cr-51 has also found limited application in radiotherapy. Historically, it was investigated for treating certain types of tumors due to its beta-emitting properties, which can deliver localized radiation. However, advancements in more targeted and effective radiotherapeutic agents have reduced its prevalence in this area.

Supply Chain and Manufacturing

The production of sodium chromate Cr-51 involves the irradiation of stable chromium isotopes in a nuclear reactor to produce the radioactive Cr-51. This process requires specialized facilities with stringent safety protocols and regulatory oversight.

Key Manufacturers

The supply of sodium chromate Cr-51 is concentrated among a limited number of global radiopharmaceutical manufacturers. These companies possess the necessary infrastructure for radioisotope production, purification, and distribution. Notable entities in this sector include:

• Curium Pharma
• ITM Radiopharma
• Nordion (part of Sterigenics)
• GE Healthcare (though their focus has shifted to newer isotopes)

The production capacity is often linked to the availability of suitable nuclear reactors and the demand cycles for other radioisotopes produced in the same facilities.

Regulatory Landscape

The handling, production, and distribution of radioactive materials like sodium chromate Cr-51 are subject to strict regulations by national and international bodies. In the United States, the Nuclear Regulatory Commission (NRC) governs its use. Similar agencies exist in other countries, such as the European Medicines Agency (EMA) in Europe. These regulations pertain to:

• Radiation Safety: Ensuring minimal radiation exposure to workers and the public.
• Quality Control: Maintaining the purity and specific activity of the radioisotope.
• Transportation: Adhering to specific guidelines for transporting radioactive materials.
• Waste Disposal: Managing radioactive waste generated during production and use.

Compliance with these regulations represents a significant cost factor for manufacturers and users.

Pricing and Revenue Streams

The pricing of sodium chromate Cr-51 is influenced by manufacturing complexity, regulatory compliance, and the relatively low but consistent demand. It is typically sold by the millicurie (mCi) or gigabecquerel (GBq) of radioactivity.

Price Structure

• Unit Price: The cost per unit of radioactivity can range from approximately $50 to $150 per mCi, depending on the supplier, purity, and quantity purchased.
• Bulk Purchasing: Larger orders from major medical institutions or distributors may secure volume discounts.
• Service Contracts: Some suppliers may offer service contracts that include delivery, dose preparation, and waste disposal, adding to the overall cost.

The total annual revenue generated by sodium chromate Cr-51 is therefore a function of the volume of doses administered and their associated prices.

Competitive Landscape and Future Outlook

The competitive landscape for sodium chromate Cr-51 is stable, with established players dominating the market. However, the long-term outlook is influenced by the emergence of alternative diagnostic and therapeutic modalities.

Competition from Newer Isotopes

While sodium chromate Cr-51 remains a valuable tool for specific studies, newer radioisotopes and imaging technologies are increasingly being adopted. For instance, Technetium-99m (Tc-99m) is the most widely used radioisotope in diagnostic nuclear medicine due to its favorable imaging characteristics and shorter half-life. Furthermore, advancements in Positron Emission Tomography (PET) imaging with isotopes like Fluorine-18 (F-18) offer higher resolution and sensitivity for certain applications.

Impact on Demand

The increasing availability and utility of these newer isotopes may lead to a gradual decline in the demand for sodium chromate Cr-51 for some of its traditional applications. However, its established protocols, specific diagnostic capabilities, and cost-effectiveness for certain patient populations ensure its continued, albeit limited, use.

Potential for Niche Growth

Despite competition, there may be opportunities for sustained demand in specific geographical regions or for particular patient cohorts where access to newer technologies is limited, or where the established efficacy of Cr-51 is sufficient for clinical needs. The ongoing need for red blood cell mass and survival studies, particularly in the context of managing chronic anemias and complex hematological disorders, supports a baseline demand.

Financial Projections

Financial projections for sodium chromate Cr-51 are based on a mature market with slow growth.

Revenue Growth

• Current Trajectory: The market is expected to experience low single-digit annual growth (0-2%) over the next five years, primarily driven by the consistent demand in specific diagnostic procedures and the established patient populations requiring these tests.
• Factors Influencing Growth:
  • Aging Population: An increasing elderly population in many developed countries may lead to a higher incidence of conditions requiring diagnostic imaging, indirectly supporting demand.
  • Healthcare Access: Expanding healthcare infrastructure in emerging economies could create new markets, although adoption may favor newer technologies.
  • Technological Obsolescence: The primary risk to revenue growth is the continued development and adoption of superior imaging techniques and radiopharmaceuticals.

Profitability

Profitability for manufacturers is contingent on optimizing production costs, maintaining regulatory compliance, and managing supply chain efficiencies.

• Operating Margins: Operating margins for radiopharmaceutical production can be substantial due to the specialized nature of the product and high barriers to entry. However, these are offset by significant capital expenditure on production facilities and ongoing R&D for safety and efficacy.
• Cost Drivers:
  • Raw Material Costs: The price of stable chromium isotopes and the cost of nuclear reactor time are key variables.
  • Regulatory Compliance: Ongoing investment in safety, licensing, and quality assurance.
  • Logistics: Specialized transportation and cold-chain management.

Investment Considerations

Investment in sodium chromate Cr-51-focused ventures is a niche strategy. Investors would need to consider:

• Market Stability: The market is unlikely to experience explosive growth but offers stability for established products.
• Technological Risk: The potential for disruptive technologies to displace current applications.
• Regulatory Environment: The impact of evolving safety and environmental regulations.
• Supply Chain Resilience: Dependence on a limited number of production facilities.

Key Takeaways

• Sodium chromate Cr-51 is a niche radioisotope with stable but limited market demand, primarily for diagnostic red blood cell studies.
• The market value is estimated in the low tens of millions of U.S. dollars annually.
• Production is concentrated among a few specialized radiopharmaceutical manufacturers adhering to stringent regulations.
• Pricing is per unit of radioactivity, influenced by production costs and safety compliance.
• The market faces competition from newer isotopes and advanced imaging technologies, suggesting a trajectory of slow growth or decline in some applications.
• Profitability for manufacturers depends on operational efficiency and regulatory adherence.
• Investment in this sector requires consideration of technological obsolescence and market stability.

Frequently Asked Questions

1. What are the primary diagnostic applications of sodium chromate Cr-51 currently? Sodium chromate Cr-51 is primarily used for red blood cell mass determination and red blood cell survival studies, aiding in the diagnosis and monitoring of various anemias and gastrointestinal bleeding.

2. Who are the main competitors or alternatives to sodium chromate Cr-51 in diagnostic imaging? Key alternatives include Technetium-99m (Tc-99m) for general SPECT imaging and various isotopes used in Positron Emission Tomography (PET) scans, such as Fluorine-18 (F-18), offering higher sensitivity and resolution for certain conditions.

3. What are the most significant regulatory hurdles for manufacturers of sodium chromate Cr-51? Significant regulatory hurdles include stringent requirements from bodies like the Nuclear Regulatory Commission (NRC) concerning radiation safety, quality control, licensing for production and handling, transportation of radioactive materials, and radioactive waste disposal.

4. What is the typical shelf-life of a dose of sodium chromate Cr-51 once it is manufactured? The shelf-life of a sodium chromate Cr-51 dose is limited by its half-life, which is approximately 27.7 days. Doses are manufactured and shipped with a specific "date of use" to ensure adequate radioactivity for diagnostic procedures.

5. Are there any emerging therapeutic applications for sodium chromate Cr-51? Currently, there are no significant emerging therapeutic applications for sodium chromate Cr-51. Its historical use in radiotherapy has largely been superseded by more advanced and targeted radiotherapeutic agents.

Citations

[1] National Center for Biotechnology Information. (n.d.). PubChem Compound Summary for CID 3083760, Chromium-51 chromate. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Chromium-51-chromate