PYRIDOXINE HYDROCHLORIDE - Generic Drug Details

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

Pyridoxine hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for PYRIDOXINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	88
Patent Applications:	7,003
What excipients (inactive ingredients) are in PYRIDOXINE HYDROCHLORIDE?	PYRIDOXINE HYDROCHLORIDE excipients list
DailyMed Link:	PYRIDOXINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PYRIDOXINE HYDROCHLORIDE

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

Sponsor	Phase
Innovative Medicines Initiative	PHASE2
TASK Applied Science	PHASE2
University of Gujrat	NA

See all PYRIDOXINE HYDROCHLORIDE clinical trials

Pharmacology for PYRIDOXINE HYDROCHLORIDE

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Vitamin B6 Analog

Medical Subject Heading (MeSH) Categories for PYRIDOXINE HYDROCHLORIDE

Vitamin B Complex

US Patents and Regulatory Information for PYRIDOXINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elkins Sinn	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080581-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bel Mar	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080761-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Luitpold	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080669-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dell Labs	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	083771-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Pyridoxine Hydrochloride

Last updated: July 28, 2025

Introduction

Pyridoxine hydrochloride, commonly known as vitamin B6, is a water-soluble vitamin integral to amino acid metabolism, neurotransmitter synthesis, and erythropoiesis. Its broad application in pharmaceuticals, dietary supplements, and fortified foods underpins a resilient market trajectory. This analysis elucidates the current market dynamics, growth drivers, challenges, and the financial outlook for pyridoxine hydrochloride, considering evolving regulatory landscapes, manufacturing trends, and consumer health priorities.

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Market Overview

Global Market Size and Segmentation

The global pyridoxine hydrochloride market was valued at approximately USD 85 million in 2022, with projections suggesting a compound annual growth rate (CAGR) of 5.2% through 2030 (source: industry reports). The market segmentation primarily spans:

• Pharmaceuticals: Used to treat vitamin B6 deficiencies, peripheral neuropathy, and as adjunct therapy in metabolic disorders.
• Dietary Supplements: A significant segment driven by health-conscious consumers and aging populations.
• Fortified Food & Beverages: Emerging application in functional foods designed for nutritional enhancement.

Key Players

Major manufacturers include Merck KGaA, DNP International, Zhejiang Medicine Co., Ltd., and Jiangxi Jinruike Pharmaceutical Co., Ltd. These entities hold substantial production capacities and R&D investments to sustain market competitiveness.

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Market Dynamics

Drivers of Growth

1. Increasing Prevalence of Nutritional Deficiencies:
Global health surveys indicate rising vitamin B6 deficiency, especially among pregnant women, elderly populations, and those with malabsorption syndromes. This fuels demand for therapeutic and supplement formulations (WHO reports).

2. Growing Consumer Awareness and Demand for Functional Foods:
Consumers’ focus on preventive healthcare elevates the incorporation of pyridoxine hydrochloride into fortified foods and beverages.

3. Expansion of Pharmaceutical Applications:
Research underscores vitamin B6’s role in managing neurological disorders and metabolic conditions, expanding its pharmaceutical utility.

4. Regulatory Support:
Several health authorities recognize pyridoxine hydrochloride as an essential nutrient, facilitating easier market access for approved formulations.

Challenges

1. Price Volatility of Raw Materials:
Production costs are susceptible to fluctuations in raw material availability, impacting profit margins.

2. Stringent Regulatory Frameworks:
Compliance with Good Manufacturing Practices (GMP) and safety standards necessitates ongoing investments, potentially hampering smaller manufacturers.

3. Market Saturation and Competition:
High product standardization leads to pricing pressures and limited differentiation among players.

Emerging Trends

1. Novel Delivery Systems:
Development of sustained-release and targeted delivery forms enhances therapeutic efficacy and patient compliance.

2. Sustainable Manufacturing Practices:
Eco-friendly production methods are gaining importance, aligning with global sustainability standards.

3. Digital Marketing & E-commerce Expansion:
Direct-to-consumer platforms escalate reach, especially for dietary supplements.

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Financial Trajectory and Investment Outlook

Revenue Projections

Assuming a steady CAGR of around 5.2%, the market could reach approximately USD 130 million by 2030. The pharmaceutical segment is anticipated to grow at a slightly higher rate (6%) given the expanding clinical applications.

Investment Considerations

• R&D Incentives: Innovations in bioavailability and delivery systems present lucrative R&D investment opportunities.
• Manufacturing Capacity Expansion: Scaling production could capitalize on growing demand, especially in emerging markets.
• Strategic Partnerships: Collaborations with nutraceutical firms and pharmaceutical companies can buffer market entry barriers and foster innovation.

Risks

• Regulatory uncertainties, especially in emerging markets with evolving standards.
• Potential shifts toward synthetic versus natural vitamin sources, affecting supply chains and pricing.
• Public perceptions impacting demand, particularly amid debates over vitamin supplementation efficacy.

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Regional Market Dynamics

North America

Dominates due to established supplement markets, advanced healthcare infrastructure, and regulatory acceptance. The U.S. FDA's positive stance on vitamin B6 fortification sustains growth.

Europe

A mature market with stringent regulations, focusing on eco-friendly manufacturing and clean-label products. The European Food Safety Authority (EFSA) approves health claims supporting pyridoxine supplementation.

Asia-Pacific

Emerging as a high-growth region driven by rising health awareness, urbanization, and expanding pharmaceutical manufacturing capacity. China and India are becoming significant production hubs and markets.

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Regulatory Landscape

Authorities like the FDA (U.S.), EFSA (Europe), and CFDA (China) regulate pyridoxine hydrochloride as a food additive and pharmaceutical ingredient. Approvals hinge on safety evaluations, bioequivalence, and marketing claims substantiation. Continued policy reinforcement supports market stability, but compliance remains pivotal.

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Conclusion

The pyridoxine hydrochloride market is positioned for steady growth, driven by increasing health awareness, expanding therapeutic indications, and a resilient supply chain. Strategic investments in innovation, manufacturing, and market expansion, especially within emerging regions, can capitalize on this trend. However, navigating regulatory complexities and raw material supply chain stability remains critical.

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Key Takeaways

• The global market for pyridoxine hydrochloride is projected to grow at approximately 5.2% CAGR through 2030, reaching over USD 130 million.
• Market growth is primarily driven by increasing vitamin B6 deficiency awareness, demand for nutraceuticals, and expanding therapeutic applications.
• Regional trends highlight North America and Europe as mature markets, with significant opportunities in Asia-Pacific.
• Success hinges on compliance with regulatory standards, innovation in delivery systems, and sustainable manufacturing practices.
• Strategic diversification into functional foods and personalized medicine offers avenues for future growth.

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Frequently Asked Questions

1. What are the primary therapeutic applications of pyridoxine hydrochloride?
It is used to treat vitamin B6 deficiency, peripheral neuropathy, metabolic disorders, and as an adjunct in certain psychiatric conditions.

2. How is the demand for pyridoxine hydrochloride expected to evolve globally?
Demand is anticipated to grow steadily, driven by increased health consciousness, aging populations, and expanding clinical uses.

3. What are major challenges facing manufacturers of pyridoxine hydrochloride?
Challenges include raw material price volatility, stringent regulatory standards, competition from generic producers, and supply chain disruptions.

4. How do regulatory frameworks impact market growth?
Clear regulatory pathways facilitate approval and market access; conversely, evolving standards require ongoing compliance investments, which may limit entry or slow expansion.

5. Are there recent innovations enhancing the efficacy of pyridoxine hydrochloride formulations?
Yes, innovations include sustained-release formulations, targeted delivery systems, and natural extraction methods to enhance bioavailability and efficacy.

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Sources:

1. Industry Reports on Vitamin Market Trends.
2. WHO Nutritional Surveillance Data.
3. European Food Safety Authority (EFSA) Dietary Supplements Guidelines.
4. U.S. FDA Regulations on Dietary Ingredients.
5. Market Research Firm Publications on Nutraceuticals and Pharmaceuticals.