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 Pharma Ltd, Luitpold, Lyphomed, Mankind Pharma, Mylan Institutional, Mylan Labs Ltd, 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, Lupin, Padagis Israel, West Ward, Ge Healthcare, and Armour Pharm, and is included in forty-five NDAs. There are six patents protecting this compound and one Paragraph IV challenge. 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:	6
Tradenames:	15
Applicants:	40
NDAs:	45
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	39
Patent Applications:	3,563
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
Fundação Educacional Serra dos Órgãos	Phase 4
University of Kansas Medical Center	Phase 2
Tanta University	Phase 3

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
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005		DISCN	Yes	No	8,003,353
Bel Mar	RUBIVITE	cyanocobalamin	INJECTABLE;INJECTION	010791-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Savage Labs	RUVITE	cyanocobalamin	INJECTABLE;INJECTION	080570-002	Approved Prior to Jan 1, 1982		DISCN	No	No
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
Mylan Labs Ltd	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	204829-001	Jun 5, 2017	AP	RX	No	No
Watson Labs	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	083120-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bel Mar	RUBIVITE	cyanocobalamin	INJECTABLE;INJECTION	010791-005	Approved Prior to Jan 1, 1982		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	9,415,007
Endo Operations	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996	4,724,231
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	8,940,714
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	8,003,353
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,879,349
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,229,636
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,404,489

Cyanocobalamin Market Analysis and Financial Projection Experimental

Cyanocobalamin Market Dynamics and Financial Trajectory

Introduction

Cyanocobalamin, a synthetic form of vitamin B12, is a crucial compound in the treatment of vitamin B12 deficiencies and various related health conditions. The market for cyanocobalamin is experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics, financial trajectory, and the various elements influencing the cyanocobalamin market.

Market Size and Growth

The global vitamin B12 market, which includes cyanocobalamin, is projected to exhibit substantial growth. By 2032, the market is expected to grow from $205.0 million in 2024 to $346.6 million, with a Compound Annual Growth Rate (CAGR) of 6.8%[4].

Key Drivers of Market Growth

Several factors are driving the growth of the cyanocobalamin market:

Increasing Health Awareness

Growing health awareness among the population, particularly regarding the importance of vitamin B12, is a significant driver. As people become more conscious of their health, the demand for dietary supplements and treatments for vitamin B12 deficiencies increases[4].

Rise in Chronic Diseases

The rising prevalence of chronic diseases such as diabetes, Alzheimer's, and pernicious anemia is contributing to the increased demand for cyanocobalamin. These conditions often require vitamin B12 supplementation, thereby boosting market demand[4].

Growing Trend of Veganism

The increasing trend of veganism is another key driver. Vegans are more likely to suffer from vitamin B12 deficiencies due to the absence of animal products in their diet, which are natural sources of vitamin B12. This has led to a higher demand for cyanocobalamin supplements[1].

Favorable Outlook on Medical Nutrition

There is a favorable outlook towards medical nutrition, which includes the use of cyanocobalamin in fortified foods and dietary supplements. This trend is expected to continue, driving market growth[1].

Market Segmentation

The cyanocobalamin market is segmented based on several criteria:

By Type

The market is segmented into cyanocobalamin injection, oral, and spray forms. The cyanocobalamin injection segment holds a major share due to its wide availability and cost-effectiveness[2][4].

By Application

The market is segmented by application into hospitals, clinics, and other settings. The demand from hospitals and clinics is significant due to the use of cyanocobalamin in treating various medical conditions[2].

By Geography

Geographically, the market is divided into North America, Europe, Asia-Pacific, and other regions. North America and Europe are significant markets due to advanced healthcare sectors and high demand for dietary supplements. The Asia-Pacific region, particularly India and other Asian nations with a large vegetarian population, also presents substantial opportunities[1][2][4].

Key Market Trends

Dominance of North America and Europe

North America and Europe are expected to continue their dominance in the market due to the advanced healthcare infrastructure and high awareness about health issues. The use of products with high dietary substance and diminished calorie levels is also a trend in these regions[1].

Growing Opportunities in Asia-Pacific

India and other Asian countries offer significant opportunities due to the large vegetarian population, which increases the demand for cyanocobalamin supplements[1].

Slow Growth in Africa and Middle East

Africa and the Middle East are expected to witness slow growth due to misconceptions about veganism and its benefits, as well as limited healthcare infrastructure in some areas[1].

Challenges and Restraints

High Dependency on China for Supply

The global market is heavily dependent on China for the supply of cyanocobalamin, which can lead to supply chain disruptions and increased costs. China produces around 90% of the world's cyanocobalamin, making it a critical but vulnerable link in the supply chain[4].

High Production Costs

The production of cyanocobalamin through fermentation is a costly and time-consuming process. This, combined with the dominance of a few key manufacturers, results in high market prices that can hinder growth[4].

Key Market Players

Several pharmaceutical and biotech companies are key players in the cyanocobalamin market, including:

• Bristol-Myers Squibb
• Endo International
• Luitpold Pharmaceuticals
• Pfizer
• Teva (Actavis)
• Merck
• Mylan
• Sanofi-Aventis
• Bayer HealthCare
• Huaxin Pharmaceutical
• Hebei Huarong Pharmaceutical[1][2][4]

Financial Trajectory

Market Size Projections

The global vitamin B12 market, including cyanocobalamin, is projected to reach $346.6 million by 2032, growing at a CAGR of 6.8% from 2024 to 2032[4].

Revenue Growth

The revenue growth is expected to be driven by increasing demand from the pharmaceutical and food industries, as well as the growing awareness of health issues. The market is quantitatively analyzed to highlight the growth scenario, with a focus on revenue projections throughout the forecast period[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical and biotechnology industries. The increased demand for COVID-19 management drugs and vaccines has presented opportunities for manufacturers, which in turn has affected the cyanocobalamin market. The pandemic has accelerated the development and supply chain management of essential drugs, including cyanocobalamin[1].

Conclusion

The cyanocobalamin market is poised for significant growth driven by increasing health awareness, the rising prevalence of chronic diseases, and the growing trend of veganism. Despite challenges such as high dependency on China for supply and high production costs, the market is expected to expand substantially over the forecast period.

Key Takeaways

• The global vitamin B12 market, including cyanocobalamin, is projected to grow to $346.6 million by 2032.
• Key drivers include increasing health awareness, the rise in chronic diseases, and the growing trend of veganism.
• The market is heavily dependent on China for supply, which poses a risk of supply chain disruptions.
• High production costs through fermentation are a significant challenge.
• North America and Europe are dominant markets, while Asia-Pacific presents growing opportunities.

FAQs

Q: What are the primary drivers of the cyanocobalamin market? A: The primary drivers include increasing health awareness, the rise in chronic diseases, and the growing trend of veganism.

Q: Which region dominates the cyanocobalamin market? A: North America and Europe currently dominate the market, but the Asia-Pacific region is expected to grow significantly.

Q: What are the challenges facing the cyanocobalamin market? A: High dependency on China for supply and high production costs are significant challenges.

Q: How is the COVID-19 pandemic affecting the cyanocobalamin market? A: The pandemic has accelerated the development and supply chain management of essential drugs, including cyanocobalamin, presenting both opportunities and challenges.

Q: What is the projected market size of the vitamin B12 market by 2032? A: The global vitamin B12 market, including cyanocobalamin, is projected to reach $346.6 million by 2032.

Sources

1. Allied Market Research - Cyanocobalamin Injection Market Size and Growth Analysis By 2030
2. Market Research Intellect - Global Vitamin B12 (Cobalamin, Cyanocobalamin) Market Size ...
3. OpenPR - Global Vitamin B12 (Cobalamin, Cyanocobalamin) Market Size
4. Fortune Business Insights - Vitamin B12 Market Size, Share, Growth | Industry Report [2032]
5. NCBI Bookshelf - Cyanocobalamin - StatPearls