CYANOCOBALAMIN - Generic Drug Details

What are the generic sources for cyanocobalamin and what is the scope of patent protection?

Cyanocobalamin is the generic ingredient in fifteen branded drugs marketed by Endo Operations, Pharmacia And Upjohn, Lilly, Watson Labs, Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Luitpold, Lyphomed, Mankind Pharma, Meitheal, Mylan Institutional, Pharmobedient, Sagent Pharms Inc, Sandoz, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Accord Hlthcare, Merck, Bel Mar, Bristol Myers Squibb, Savage Labs, Bayer Hlthcare, Ph Health, Lupin, Padagis Israel, West Ward, Ge Healthcare, and Armour Pharm, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cyanocobalamin. Twenty-four suppliers are listed for this compound.

Summary for CYANOCOBALAMIN

US Patents:	0
Tradenames:	15
Applicants:	42
NDAs:	46
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Drug Prices:	Drug price trends for CYANOCOBALAMIN
Drug Sales Revenues:	Drug sales revenues for CYANOCOBALAMIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYANOCOBALAMIN
What excipients (inactive ingredients) are in CYANOCOBALAMIN?	CYANOCOBALAMIN excipients list
DailyMed Link:	CYANOCOBALAMIN at DailyMed

See drug prices for CYANOCOBALAMIN

See drug sales revenues for CYANOCOBALAMIN

Recent Clinical Trials for CYANOCOBALAMIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Laboratorios Silanes S.A. de C.V.	PHASE3
Fundação Educacional Serra dos Órgãos	Phase 4
University of Kansas Medical Center	Phase 2

See all CYANOCOBALAMIN clinical trials

Pharmacology for CYANOCOBALAMIN

Drug Class

Vitamin B12

Anatomical Therapeutic Chemical (ATC) Classes for CYANOCOBALAMIN

B03BA	Vitamin B12 (cyanocobalamin and analogues)
B03B	VITAMIN B12 AND FOLIC ACID
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for CYANOCOBALAMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASCOBAL	Nasal Spray	cyanocobalamin	500 mcg/spray	021642	1	2017-04-28

US Patents and Regulatory Information for CYANOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Luitpold	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	080668-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	083120-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Solopak	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	087551-001	Feb 29, 1984		DISCN	No	No
Bristol Myers Squibb	RUBRAMIN PC	cyanocobalamin	INJECTABLE;INJECTION	006799-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Eugia Pharma	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	213874-001	Dec 8, 2020	AP	RX	No	No
Sagent Pharms Inc	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	215107-001	Nov 15, 2022	AP	RX	No	No
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996		DISCN	No	No

Expired US Patents for CYANOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005

Market Dynamics and Financial Trajectory for Cyanocobalamin

Last updated: July 27, 2025

Introduction

Cyanocobalamin, a synthetic form of vitamin B12, serves as a critical therapeutic agent in the management of vitamin B12 deficiency, pernicious anemia, and certain neurological disorders. Predominantly administered via injections or oral supplements, cyanocobalamin’s well-established clinical efficacy and broad application spectrum ensure its sustained demand within global healthcare markets. This article analyzes the evolving market dynamics and projects financial trajectories for cyanocobalamin, highlighting factors influencing growth, competitive landscape, regulatory considerations, and future revenue prospects.

Market Landscape and Key Drivers

Global Prevalence of Vitamin B12 Deficiency

The expanding prevalence of vitamin B12 deficiency underpins the robust demand for cyanocobalamin. According to the World Health Organization (WHO), this deficiency affects approximately 6-20% of various population groups worldwide, driven by factors including malnutrition, malabsorption syndromes, vegetarian and vegan diets, and aging populations [1]. As the global population ages, age-related malabsorption and neurological complications elevate the prominence of cyanocobalamin therapy.

Healthcare Infrastructure and Screening Programs

Growing awareness and screening initiatives for nutrient deficiencies facilitate early diagnosis and treatment, bolstering cyanocobalamin demand. Countries investing in healthcare infrastructure are more proficient at integrating deficiency screenings, further promoting therapeutic use.

Therapeutic Application Expansion

Beyond deficiency correction, cyanocobalamin’s role in managing neurological conditions, metabolic disorders, and as a supportive therapy in chemotherapy-induced anemia broadens its market scope. Development of combination therapies involving cyanocobalamin signals potential for increased indications and formulation innovations.

Patent and Market Exclusivity

Cyanocobalamin’s status as a generic drug ensures widespread availability and affordability, fostering consumption. However, patent expirations for branded formulations open opportunities for generic manufacturers to capture larger market segments at reduced prices.

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Market Challenges and Constraints

Competition from Alternative Forms

Emerging vitamin B12 formulations, notably methylcobalamin and hydroxocobalamin, compete with cyanocobalamin. Certain studies suggest methylcobalamin may have enhanced bioavailability or neurological efficacy, which could influence prescribing patterns [2]. The choice of formulation depends on clinical indications and regional preferences.

Regulatory and Quality Standards

Harmonization of manufacturing standards and regulatory approvals impacts market access. Stringent quality controls, especially in emerging markets, are critical to meet international standards, affecting production costs and pricing strategies.

Supply Chain and Raw Material Availability

The global supply chain for raw materials such as cyanide and cobalt—integral to cyanocobalamin synthesis—can influence production costs and volume. Disruptions due to geopolitical or environmental factors pose potential risks to supply stability.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance

The global cyanocobalamin market has experienced steady growth driven by increasing prevalence of deficiency and aging demographics. Market estimates place the global vitamin B12 supplement market—dominated by cyanocobalamin—at approximately USD 1.4 billion in 2022, with an annual compound growth rate (CAGR) of around 5% over the past five years [3].

Market Segmentation and Regional Analysis

• Developed Markets: North America and Western Europe account for significant shares, driven by high awareness, advanced healthcare infrastructure, and reimbursement support. The U.S. leads with extensive screening programs and Medicare coverage for deficiency management.
• Emerging Markets: Asia-Pacific and Latin America are witnessing rapid growth, propelled by rising healthcare access, increasing prevalence of deficiency, and affordability of generic formulations.

Projecting Future Financial Trends

Market analysts predict augmented growth trajectories for cyanocobalamin, with projections indicating a CAGR of approximately 5-7% from 2023 to 2030. Key factors include:

• Population Aging: The global elderly population is expected to reach nearly 1.5 billion by 2030 [4], escalating demand.
• Enhanced Awareness: Increasing public and healthcare provider awareness fosters early intervention.
• Product Innovations: Development of sustained-release formulations and improved delivery methods may optimize treatment outcomes and expand application scopes.
• Regulatory Incentives: Supportive policies for supplement fortification can open new revenue streams, particularly in developing countries.

Impact of COVID-19 Pandemic

The pandemic underscored the vulnerability of supply chains and accelerated telehealth adoption. While immediate impacts include disruptions in supply and distribution, the overall market demonstrated resilience due to continued demand for deficiency management. Furthermore, COVID-19-associated neurological or hematological complications have positioned cyanocobalamin as a supportive therapeutic option.

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Competitive Landscape

Major players in the cyanocobalamin market encompass both pharmaceutical giants and generic manufacturers. Companies such as Pfizer, Novartis, and local producers in emerging markets hold significant manufacturing, distribution, and R&D capacities.

Generic manufacturers benefit from the expiration of patents, enabling proliferation of low-cost formulations. Strategic alliances, mergers, and investments in production capacity are prevalent to maintain market share.

Innovation is primarily focused on improving bioavailability and ease of administration — including injectable, oral, and sublingual delivery systems. Patent protections for novel formulations and delivery devices could generate premium pricing and market exclusivity.

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Regulatory Environment and Market Access

Regulatory authorities such as the FDA (U.S.), EMA (Europe), and MHRA (UK) regulate cyanocobalamin products, emphasizing manufacturing quality, efficacy, and safety. While cyanocobalamin is generally recognized as safe (GRAS), regulatory hurdles can influence market entry timelines and costs.

In developing markets, approval processes may be lengthier, but government-led initiatives for supplementation and deficiency screening increase product demand.

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Environmental and Ethical Considerations

Sustainability concerns related to raw material sourcing, especially cobalt and cyanide derivatives, influence manufacturing practices. Ethical sourcing and environmental responsibility are increasingly important to consumers and regulators, impacting product acceptance and corporate reputation.

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Key Success Factors and Recommendations

• Focus on Product Differentiation: Innovate delivery systems, formulations, or combination therapies to improve patient compliance and therapeutic efficacy.
• Expand Access in Emerging Markets: Regulatory strategies aligned with local policies, affordable pricing models, and robust distribution channels can unlock substantial growth.
• Enhance Supply Chain Resilience: Diversify raw material sources and optimize manufacturing processes to mitigate disruptions.
• Invest in Education and Awareness: Collaborate with healthcare providers and public health agencies to promote early detection and treatment.
• Align with Regulatory Changes: Stay abreast of evolving standards and participate in shaping policies conducive to product approval and market penetration.

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Key Takeaways

• Growing Demand: The prevalence of vitamin B12 deficiency, aging populations, and expanded therapeutic indications underpin sustained demand for cyanocobalamin globally.
• Market Growth Trajectory: Forecasts indicate a CAGR of approximately 5-7% through 2030 driven by demographic trends, product innovation, and increased healthcare awareness.
• Competitive Dynamics: The market is characterized by a mix of branded and generic players, with price sensitivity in emerging markets and innovation serving as key differentiators.
• Regulatory and Supply Considerations: Stringent quality standards, raw material sourcing, and regulatory approvals substantially influence market accessibility and costs.
• Emerging Opportunities: Product innovation, market expansion strategies, and sustainable manufacturing practices can offer competitive advantage and growth momentum.

FAQs

1. What are the main therapeutic applications of cyanocobalamin?
   Cyanocobalamin is primarily used to treat vitamin B12 deficiency, pernicious anemia, and neurological disorders associated with deficiency. It is also employed as supportive therapy in certain chemotherapy regimens.

2. How does cyanocobalamin compare with alternative vitamin B12 forms?
   Cyanocobalamin is stable, cost-effective, and widely used. Alternative forms like methylcobalamin and hydroxocobalamin may offer better absorption or neurological benefits but are often more expensive and less routinely prescribed.

3. What factors influence the price fluctuations of cyanocobalamin?
   Raw material costs, manufacturing costs, regulatory compliance expenses, and market competition significantly impact pricing. Patent expirations of branded formulations also introduce price competition in the generic market.

4. What are the prevalent regulatory challenges for cyanocobalamin manufacturers?
   Manufacturers must meet stringent quality standards set by authorities like the FDA and EMA, which include demonstrating safety, efficacy, and manufacturing quality. Navigating diverse regional approval processes can be complex and time-consuming.

5. What future innovations could impact cyanocobalamin's market?
   Developments include sustained-release formulations, novel delivery devices for improved adherence, combination therapies, and sustainable sourcing practices. Advances in nanotechnology and bioengineering may further expand therapeutic applications.

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References

[1] WHO. Micronutrient Deficiency. World Health Organization. 2020.

[2] K. S. S. Sai et al., "Bioavailability and clinical efficacy of methylcobalamin versus cyanocobalamin," Journal of Clinical Nutrition, 2019.

[3] MarketsandMarkets. Vitamin B12 Market by Form, Application, and Region — Global Forecast to 2027. 2022.

[4] United Nations. World Population Ageing 2020 Highlights. 2020.