Last Updated: August 2, 2026

cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 - Profile


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What are the generic drug sources for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 and what is the scope of patent protection?

Cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare DICOPAC KIT cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58 N/A;N/A 017406-001 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

Investment Analysis for Cyanocobalamin and Its Isotopic Variants

Last updated: March 13, 2026

What is Cyanocobalamin and How Is It Marketed?

Cyanocobalamin is a synthetic form of vitamin B12 used to treat and prevent B12 deficiency. It is a standard ingredient in pharmaceuticals, supplements, and fortification products. Its global market size was valued at approximately USD 2.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-6% over the next five years [1].

The molecule is a stable, inexpensive, and widely approved form of vitamin B12. It is supplied mainly as injectable, oral, or sublingual formulations. Major manufacturers include institutions in North America, Europe, and Asia, with India and China emerging as significant producers of bulk cyanocobalamin [2].

What Are Cyanocobalamin Co-57 and Co-58?

Cyanocobalamin Co-57 and Co-58 are isotopically labeled variants incorporating cobalt isotopes Co-57 and Co-58. These isotopes serve primarily in pharmaceutical and research contexts such as:

  • Diagnostic imaging
  • Radioactive tracer studies
  • Pharmacokinetic research

Neither isotope-enriched forms are widely commercialized for therapeutic purposes, but their potential applications include radiopharmaceutical development, which could position them as niche high-value products.

Market and Investment Fundamentals

Aspect Cyanocobalamin (Standard) Cyanocobalamin Co-57 Cyanocobalamin Co-58
Market Size (2022) USD 2.5 billion Not widely estimated Not widely estimated
Growth Drivers Vitamin deficiency awareness Research and diagnostic use Research and niche radiopharmaceuticals
Manufacturing Complexity Low Moderate (requires isotope procurement) Moderate (requires isotope procurement)
Regulatory Environment Well-established Complex (radioactive handling) Complex (radioactive handling)
Key Players Pfizer, Merck, local producers N/A N/A
Pricing Low ($10–$50 per gram) High (hundreds to thousands of dollars per dose/radio-pharmaceutical) High

Investment Considerations

Cyanocobalamin Market

  • Mature but consistent demand influenced by health supplements and deficiency treatment.
  • Commodity status means margins are compressed but stable.
  • Potential growth from increasing elderly population and nutritional deficiencies.

Isotope-Enriched Variants (Co-57 and Co-58)

  • Limited market, primarily research and specialized diagnostics.
  • Suppliers include isotope producers such as Isotope Technologies Gera (Germany), and international radiopharmaceutical firms.
  • Revenue potential hinges on regulatory approvals, research funding, and hospital adoption of nuclear medicine procedures.

Supply Chain and Regulatory Risks

  • Cyanocobalamin production depends on raw materials like cyanide, cobalt salts, and stabilizers.
  • Isotopic variants require access to cobalt isotopes, which are limited and costly.
  • Radioactive isotopes face strict regulation, limited shelf life, and handling requirements that affect production and distribution.

Investment Opportunities

  • Companies producing bulk cyanocobalamin have stable cash flows.
  • Development of isotope-labeled variants can provide margins with high entry barriers.
  • Future growth depends on adoption by nuclear medicine, regulatory approval pathways, and R&D funding.

Comparative Outlook

Factor Cyanocobalamin Co-57 & Co-58 Variants
Market Size Large, mature Small, niche
Margins Low, steady High, volatile
Technology Complexity Low High (radioactive handling)
Regulatory Stringency Moderate High
Growth Potential Moderate High (if diagnostic applications expand)

Key Risks

  • Market saturation for standard cyanocobalamin.
  • Regulatory barriers and safety issues for isotopic forms.
  • Supply chain disruptions for cobalt isotopes.
  • Shift to alternative vitamin B12 forms or delivery systems.

Strategic Recommendations

  • For investors interested in established markets, focus on companies with efficient manufacturing aligned with global demand.
  • For speculative plays, target organizations involved in radiopharmaceutical development and isotope supply chains.
  • Monitor technological advances and regulatory changes influencing nuclear medicine applications.

Key Takeaways

  • Cyanocobalamin remains a low-margin, high-volume pharmaceutical product.
  • Isotope variants (Co-57, Co-58) have high-reward potential in diagnostics but carry significant regulatory and technical risks.
  • Growth in the sector depends on aging populations, research funding, and nuclear medicine adoption.
  • Limited competition exists for isotope-enriched forms due to high barriers to entry.
  • Long-term value hinges on biotech innovation and regulatory pipeline progress.

FAQs

1. What is the primary use of cyanocobalamin?
Treating vitamin B12 deficiency and preventing anemia.

2. How does the market for isotopic Co-57 and Co-58 differ from standard cyanocobalamin?
The isotopic variants serve diagnostic and research purposes, with limited commercial demand compared to the large, steady market for non-radioactive forms.

3. What are the main risks for investing in radiolabeled cyanocobalamin?
Regulatory hurdles, supply chain limitations for cobalt isotopes, safety concerns, and uncertain adoption in clinical settings.

4. Which regions dominate cyanocobalamin production?
North America and Europe dominate manufacturing; India and China are growing producers for bulk material.

5. What future trends could affect this market?
Advancements in nuclear medicine, new radiopharmaceuticals, alternate forms of vitamin B12, and regulatory changes.


References

[1] MarketWatch. (2023). Vitamin B12 Market Size, Share & Trends. Retrieved from https://www.marketwatch.com/

[2] GlobalData. (2022). Cyanocobalamin production and supply analysis. Marketed by pharmaceutical companies.

[3] IAEA. (2022). Radionuclide Production and Applications. International Atomic Energy Agency.

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