HYDROXOCOBALAMIN - Generic Drug Details

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

Hydroxocobalamin is the generic ingredient in four branded drugs marketed by Merck, Btg Intl, Abraxis Pharm, Actavis, Watson Labs, and Bel Mar, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for hydroxocobalamin. Two suppliers are listed for this compound.

Summary for HYDROXOCOBALAMIN

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	870
Drug Prices:	Drug price trends for HYDROXOCOBALAMIN
What excipients (inactive ingredients) are in HYDROXOCOBALAMIN?	HYDROXOCOBALAMIN excipients list
DailyMed Link:	HYDROXOCOBALAMIN at DailyMed

See drug prices for HYDROXOCOBALAMIN

Recent Clinical Trials for HYDROXOCOBALAMIN

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

Sponsor	Phase
Mayo Clinic	Phase 4
General Oncology, Inc.	Phase 1
Joshua Korzenik	Phase 2

See all HYDROXOCOBALAMIN clinical trials

Pharmacology for HYDROXOCOBALAMIN

Drug Class

Antidote

Medical Subject Heading (MeSH) Categories for HYDROXOCOBALAMIN

Hematinics

Vitamin B Complex

Anatomical Therapeutic Chemical (ATC) Classes for HYDROXOCOBALAMIN

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

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for HYDROXOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abraxis Pharm	HYDROXOCOBALAMIN	hydroxocobalamin	INJECTABLE;INJECTION	084921-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Actavis	HYDROXOCOBALAMIN	hydroxocobalamin	INJECTABLE;INJECTION	085998-001	Approved Prior to Jan 1, 1982		RX	No	Yes
Merck	ALPHAREDISOL	hydroxocobalamin	INJECTABLE;INJECTION	080778-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bel Mar	HYDROXOMIN	hydroxocobalamin	INJECTABLE;INJECTION	084629-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011		RX	Yes	Yes
Watson Labs	HYDROXOCOBALAMIN	hydroxocobalamin	INJECTABLE;INJECTION	085528-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006		DISCN	No	No

Expired US Patents for HYDROXOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006	5,834,448
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011	5,834,448

EU/EMA Drug Approvals for HYDROXOCOBALAMIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
SERB SA	Cyanokit	hydroxocobalamin	EMEA/H/C/000806 Treatment of known or suspected cyanide poisoning.Cyanokit is to be administered together with appropriate decontamination and supportive measures.	Authorised	no	no	no	2007-11-23

HYDROXOCOBALAMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydroxocobalamin

Introduction

Hydroxocobalamin, a form of vitamin B12, is a crucial medication used in the management and treatment of vitamin B12 deficiency and acute cyanide toxicity. Here, we delve into the market dynamics and financial trajectory of hydroxocobalamin, highlighting key factors driving its growth and challenges it faces.

Global Vitamin B12 Market Overview

The global vitamin B12 market, which includes hydroxocobalamin, is projected to experience significant growth. The market size is expected to increase from $205.0 million in 2024 to $346.6 million by 2032, at a Compound Annual Growth Rate (CAGR) of 6.8% during the forecast period[1].

Market Segmentation

The vitamin B12 market is segmented by type, application, and geography.

By Type

• Hydroxocobalamin: While cyanocobalamin holds the majority share due to its stability and cost-effectiveness, hydroxocobalamin is gaining traction for its specific medical applications. It is particularly useful in treating vitamin B12 deficiency secondary to conditions that impair GI tract absorption, such as malabsorption and pernicious anemia[2].

By Application

• Pharmaceutical Industry: Hydroxocobalamin is widely used in the pharmaceutical industry for treating macrocytic anemia, Leber optic atrophy, and as an antidote for cyanide poisoning. The growing demand for these treatments is a key driver for the segment[2].
• Food & Nutraceuticals Industry: Although hydroxocobalamin is not as commonly used in food fortification as other forms of vitamin B12, the overall growth in the food & nutraceuticals industry contributes to the broader market dynamics[1].

Key Drivers of Growth

Several factors are driving the growth of the hydroxocobalamin market:

Increasing Prevalence of Vitamin B12 Deficiency

The rising prevalence of chronic diseases, pernicious anemia, and vitamin B12 deficiency are significant drivers. As the global population ages and the incidence of these conditions increases, the demand for hydroxocobalamin is expected to rise[1].

Growing Health Awareness

Increased health awareness among consumers is leading to a higher demand for vitamin B12 supplements, including hydroxocobalamin. This trend is particularly pronounced in regions with advanced healthcare sectors focusing on preventative care[1].

Medical Applications

Hydroxocobalamin's unique medical applications, such as treating cyanide poisoning and neurological conditions, make it an essential product in the pharmaceutical industry. The FDA-approved form of intravenous hydroxocobalamin for cyanide poisoning further solidifies its market position[2].

Regional Market Dynamics

The market for hydroxocobalamin varies significantly across different regions:

Europe

Europe is anticipated to grow rapidly due to advancements in research and innovation in the healthcare and nutrition industries. The high prevalence of pernicious anemia in this region also contributes to the demand for hydroxocobalamin[1].

North America

North America holds a considerable share in the market, driven by the advanced healthcare sector, the availability of a wide range of products, and the growing prevalence of neural conditions and gastrointestinal issues[1].

Asia Pacific

The Asia Pacific region, particularly China, plays a crucial role in the production of vitamin B12, including hydroxocobalamin. However, the market growth in this region is also influenced by the increasing awareness and rising prevalence of Neglected Tropical Diseases (NTDs) and micronutrient malnourishment[1].

Challenges

Despite the growth potential, the hydroxocobalamin market faces several challenges:

High Production Costs

The commercial production of cobalamin, including hydroxocobalamin, is primarily through fermentation, which increases production costs. The dominance of a few key manufacturers and the large dependence on China for supply further exacerbate these costs[1].

Market Concentration

The market is dominated by a few key players such as EUROAPI, CSPC Pharmaceutical Group Co., Ltd., and Ningxia Kingvit Pharmaceutical. This concentration can lead to higher prices and reduced competition[1].

Financial Trajectory

The financial trajectory of the hydroxocobalamin market is closely tied to the overall vitamin B12 market:

Market Size and Growth

The global vitamin B12 market, including hydroxocobalamin, is valued at around $288 million in 2024 and is projected to register a CAGR of around 9.19% during the forecast period of 2024-2030[4].

Revenue Segments

The revenue from hydroxocobalamin is expected to grow significantly due to its increasing use in pharmaceutical applications. The segment's growth is driven by the demand for treatments of vitamin B12 deficiency and cyanide poisoning[2].

Key Players

Major players in the vitamin B12 market, including hydroxocobalamin, are:

• EUROAPI
• CSPC Pharmaceutical Group Co., Ltd.
• Ningxia Kingvit Pharmaceutical
• Hebei Yuxing

These companies are investing in research and development to enhance production technologies and expand their product portfolios[1].

Conclusion

The market for hydroxocobalamin is poised for significant growth driven by increasing health awareness, rising prevalence of vitamin B12 deficiency, and its unique medical applications. However, the market faces challenges such as high production costs and market concentration. As the global demand for vitamin B12 supplements continues to rise, hydroxocobalamin is expected to play a crucial role in the pharmaceutical and healthcare sectors.

Key Takeaways

• The global vitamin B12 market, including hydroxocobalamin, is projected to grow at a CAGR of 6.8% from 2024 to 2032.
• Hydroxocobalamin is used in treating vitamin B12 deficiency and cyanide poisoning.
• The market is driven by growing health awareness and the increasing prevalence of chronic diseases.
• Europe and North America are significant regions for the market due to advanced healthcare sectors and high prevalence of pernicious anemia.
• High production costs and market concentration are key challenges.

FAQs

Q: What are the primary medical applications of hydroxocobalamin? A: Hydroxocobalamin is used in the prevention and treatment of macrocytic anemia associated with vitamin B12 deficiency, Leber optic atrophy, and as an antidote for cyanide poisoning[2].

Q: Which regions are expected to drive the growth of the hydroxocobalamin market? A: Europe and North America are anticipated to drive the growth due to advancements in healthcare and the high prevalence of pernicious anemia[1].

Q: What are the challenges facing the hydroxocobalamin market? A: High production costs due to fermentation and market concentration among a few key manufacturers are significant challenges[1].

Q: Who are the major players in the vitamin B12 market, including hydroxocobalamin? A: Major players include EUROAPI, CSPC Pharmaceutical Group Co., Ltd., and Ningxia Kingvit Pharmaceutical[1].

Q: What is the projected CAGR for the global vitamin B12 market from 2024 to 2032? A: The global vitamin B12 market is projected to grow at a CAGR of 6.8% from 2024 to 2032[1].

Sources

1. Fortune Business Insights - Vitamin B12 Market Size, Share, Growth | Industry Report [2032][1]
2. NCBI Bookshelf - Hydroxocobalamin - StatPearls[2]
3. Market Research Intellect - Global vitamin b12 cyanocobalamin market size forecast[3]
4. MarkNtel Advisors - Vitamin B12 Market Share, Industry Size, Forecast 2030[4]