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:	146
Clinical Trials:	80
Patent Applications:	6,515
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
Anahuac University	N/A
Valenta Pharm JSC	N/A
All India Institute of Medical Sciences, New Delhi	Phase 2/Phase 3

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
Dell Labs	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	083772-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dr Reddys	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080572-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	HEXA-BETALIN	pyridoxine hydrochloride	INJECTABLE;INJECTION	080854-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	087967-001	Oct 1, 1982		DISCN	No	No
Luitpold	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080669-001	Approved Prior to Jan 1, 1982		DISCN	No	No

PYRIDOXINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pyridoxine Hydrochloride

Market Overview

Pyridoxine hydrochloride, a water-soluble vitamin B6, is a crucial component in various industries, including pharmaceuticals, food and beverages, and animal feed. The market for pyridoxine hydrochloride is driven by several key factors that influence its growth and financial trajectory.

Market Growth and Forecast

The global pyridoxine hydrochloride market is projected to experience significant growth over the coming years. According to Reports and Data, the market is forecasted to reach USD 731.5 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 8.0% during the forecast period from 2018 to 2028[1].

Another forecast by IndustryARC indicates that the vitamin B6 (pyridoxine) market is expected to reach $712.36 million by 2030, with a CAGR of 5.80% during the period from 2024 to 2030[3].

Drivers of Market Growth

Increasing Demand in Pharmaceutical Sector

The pharmaceutical sector is a major driver of the pyridoxine hydrochloride market. Pyridoxine hydrochloride is used to treat various conditions, including vitamin B6 deficiency, nausea and vomiting during pregnancy, and certain inborn errors of metabolism. The FDA has approved specific formulations of pyridoxine hydrochloride for these uses, contributing to its market growth[2].

Fortification of Food and Animal Feed

Mandatory fortification of food with vitamins, including vitamin B6, is a significant driver. This practice is widespread in many countries, leading to increased demand for pyridoxine hydrochloride. Additionally, the use of pyridoxine hydrochloride in animal feeds to ensure nutritional adequacy for livestock further boosts the market[3][4].

Impact of COVID-19

The COVID-19 pandemic has accelerated the trend of consumers adopting proactive health and wellness strategies, leading to an increased demand for dietary supplements, including vitamin B6. This surge in demand has positively impacted the market for pyridoxine hydrochloride[3].

Regional Market Dynamics

Asia Pacific Dominance

The Asia Pacific region is expected to lead the market due to the presence of major manufacturing countries like China and high demand for animal feeds in this region. The region's dominance is attributed to its large manufacturing capacity and growing demand for nutritional supplements[1].

North America Market Share

North America holds a significant share in the vitamin B6 market, driven by the rising geriatric population and increasing awareness about healthy eating habits and supplementation. The presence of major players in this region also contributes to its market growth[3].

Challenges and Restraints

Adverse Effects and Toxicity

Long-term use of pyridoxine hydrochloride can result in adverse effects such as changes in blood electrolytes, muscle weakness, heart function disorders, and liver damage. These risks can negatively impact market growth if not managed properly[1].

Supply Chain Disruptions

The COVID-19 pandemic has caused supply chain disruptions, which can impact the availability and pricing of pyridoxine hydrochloride. Such disruptions can act as restraints to the market growth if they persist[3].

Financial Trajectory

Revenue Growth

The market for pyridoxine hydrochloride is expected to see substantial revenue growth. With a projected market size of USD 731.5 million by 2028 and $712.36 million by 2030, the financial trajectory indicates a steady and significant increase in revenue over the forecast periods[1][3].

Key Strategies by Market Players

Companies in the pyridoxine hydrochloride market are adopting various strategies to retain their market share and drive growth. These include new product launches, partnerships, acquisitions, and mergers. Key players such as DSM Tianxin Pharmaceutical, Hegno, Huazhong Pharmaceutical, and BASF Human Nutrition are actively engaging in these strategies to maintain their competitive edge[1].

Pharmaceutical and Industrial Applications

Pharmaceutical Uses

Pyridoxine hydrochloride is used in various pharmaceutical applications, including the treatment of vitamin B6 deficiency, nausea and vomiting during pregnancy, and certain inborn errors of metabolism. Its use in medication, both orally and through injection, contributes significantly to the market revenue[2].

Food and Animal Feed

The compound is also used in the food and beverage industry for fortification purposes and in animal feeds to ensure nutritional adequacy. These applications are crucial for the market's financial health and growth[4].

Market Segmentation

The global pyridoxine hydrochloride market is segmented based on form, grade, end-user, and region. Understanding these segments helps in tailoring strategies to meet specific market needs and capitalize on growth opportunities[1][4].

Key Takeaways

• The pyridoxine hydrochloride market is forecasted to grow significantly, reaching USD 731.5 million by 2028 and $712.36 million by 2030.
• The Asia Pacific region is expected to dominate the market due to its large manufacturing capacity and high demand for animal feeds.
• The pharmaceutical sector, food fortification, and animal feed industries are major drivers of the market.
• COVID-19 has accelerated the demand for dietary supplements, positively impacting the market.
• Adverse effects and supply chain disruptions are potential restraints to market growth.

FAQs

1. What is the forecasted growth rate of the pyridoxine hydrochloride market?

The pyridoxine hydrochloride market is forecasted to grow at a CAGR of 8.0% from 2018 to 2028 and 5.80% from 2024 to 2030[1][3].

2. Which region is expected to lead the pyridoxine hydrochloride market?

The Asia Pacific region is expected to lead the market due to its major manufacturing countries and high demand for animal feeds[1].

3. What are the primary drivers of the pyridoxine hydrochloride market?

The primary drivers include increasing demand in the pharmaceutical sector, mandatory fortification of food, and the impact of COVID-19 on health and wellness trends[1][3].

4. What are the potential restraints to the market growth?

Potential restraints include adverse effects associated with long-term use and supply chain disruptions caused by events like the COVID-19 pandemic[1][3].

5. How is pyridoxine hydrochloride used in different industries?

Pyridoxine hydrochloride is used in the pharmaceutical industry for treating various conditions, in the food industry for fortification, and in animal feeds to ensure nutritional adequacy[2][4].

Cited Sources:

1. Reports and Data, "Pyridoxine Hydrochloride Market | Demand & Growth, 2020-2028"
2. NCBI Bookshelf, "Vitamin B6 (Pyridoxine) - StatPearls"
3. IndustryARC, "Vitamin B6 (Pyridoxine) Market Size Report, 2024-2030"
4. Coherent Market Insights, "Pyridoxine Hydrochloride Vitamin B6 Market Size & Share Analysis"