Introduction
Hydroxocobalamin, with the NDC code 0591-2888, is a vital medication used primarily for the treatment of vitamin B12 deficiency and pernicious anemia. Here, we will delve into the market dynamics and financial trajectory of this drug.
Market Overview
Hydroxocobalamin is a generic version of the drug, which has been on the market since 2010, following the approval of the Abbreviated New Drug Application (ANDA) by the FDA[3][4].
Key Players
The market for hydroxocobalamin is dominated by several pharmaceutical companies, including Actavis Pharma, Inc. (now part of Teva Pharmaceuticals), which is the primary labeler and distributor of the drug[1][3].
Demand and Usage
The demand for hydroxocobalamin is driven by the prevalence of vitamin B12 deficiency, which can arise from various factors including dietary deficiencies, particularly in strict vegetarians and their breast-fed infants, and pernicious anemia.
Clinical Indications
- Pernicious Anemia: Hydroxocobalamin is indicated for both uncomplicated and nervous system-involved pernicious anemia.
- Dietary Deficiency: It is used to treat dietary deficiencies of vitamin B12[3].
Supply Chain and Availability
The supply chain for hydroxocobalamin has faced some challenges, particularly in recent years.
Drug Shortages
There have been intermittent shortages of hydroxocobalamin solution for intramuscular injection, with Teva Pharmaceuticals experiencing backorders due to insufficient supply. The exact reason for these shortages has not been disclosed by the company[4].
Pricing and Cost
The pricing of hydroxocobalamin can vary depending on the region, insurance coverage, and the specific product formulation.
Generic Competition
As a generic drug, hydroxocobalamin benefits from lower production costs compared to branded drugs. This makes it more affordable for patients and contributes to its market competitiveness. Teva's generic version, for example, is designed to save patients money on their prescriptions[2].
Financial Performance
The financial performance of hydroxocobalamin is influenced by several factors, including market demand, competition, and supply chain stability.
Revenue Generation
Given its widespread use and the large patient base, hydroxocobalamin generates significant revenue for its manufacturers. Teva Pharmaceuticals, for instance, is a global leader in generics and biopharmaceuticals, with around 200 million people worldwide using one of their medicines every day[2].
Impact of Shortages
Drug shortages can negatively impact the financial trajectory by reducing available supply and potentially increasing costs due to the need for alternative treatments or expedited shipping. However, companies like Teva continue to release supplies as they become available to mitigate these effects[4].
Regulatory Environment
The regulatory environment plays a crucial role in the market dynamics of hydroxocobalamin.
FDA Approval and Oversight
Hydroxocobalamin is approved under an ANDA, which allows for the marketing of a generic version of the drug. The FDA oversees the manufacturing, labeling, and distribution of the drug to ensure compliance with safety and efficacy standards[1][3].
Patient Access and Affordability
Patient access and affordability are key considerations in the market dynamics of hydroxocobalamin.
Accessibility
Teva Pharmaceuticals emphasizes making healthcare more accessible, which includes ensuring that quality medicines like hydroxocobalamin are available to a wide range of patients. This commitment to accessibility is a significant factor in the drug's market success[2].
Future Outlook
The future outlook for hydroxocobalamin is generally positive, driven by ongoing demand and the continued need for effective treatments for vitamin B12 deficiency.
Market Growth
The market for hydroxocobalamin is expected to grow as the global population ages and the prevalence of conditions requiring vitamin B12 supplementation increases.
Addressing Shortages
Efforts to address drug shortages, such as improving manufacturing capacity and supply chain resilience, will be crucial in maintaining a stable market for hydroxocobalamin.
Key Takeaways
- Market Demand: Driven by the prevalence of vitamin B12 deficiency and pernicious anemia.
- Supply Chain: Faces intermittent shortages, but companies are working to release supplies as they become available.
- Pricing: Competitive due to generic status.
- Financial Performance: Significant revenue generation despite challenges from shortages.
- Regulatory Environment: Approved under ANDA with FDA oversight.
- Patient Access: Emphasis on making the drug accessible and affordable.
FAQs
-
What is the primary use of hydroxocobalamin?
Hydroxocobalamin is primarily used to treat vitamin B12 deficiency and pernicious anemia.
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Who are the key manufacturers of hydroxocobalamin?
Key manufacturers include Actavis Pharma, Inc. (now part of Teva Pharmaceuticals).
-
Why are there shortages of hydroxocobalamin?
The exact reason for the shortages has not been disclosed by the company, but it is related to insufficient supply.
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How does the generic status of hydroxocobalamin affect its pricing?
The generic status makes hydroxocobalamin more affordable compared to branded drugs.
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What is the regulatory status of hydroxocobalamin?
Hydroxocobalamin is approved under an Abbreviated New Drug Application (ANDA) and is subject to FDA oversight.
Sources
- FDA.report - NDC 0591-2888 - FDA.report
- Teva Pharmaceuticals USA - Hydroxocobalamin Injection, USP
- DailyMed - HYDROXOCOBALAMIN injection, solution
- ASHP - Hydroxocobalamin Solution for Intramuscular Injection
- NDC List - NDC Package Code: 0591-2888-30 Hydroxocobalamin
