You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: January 29, 2026

THIAMINE HYDROCHLORIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for thiamine hydrochloride and what is the scope of freedom to operate?

Thiamine hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Abraxis Pharm, Aspiro, Bel Mar, Caplin, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hospira, Luitpold, Mylan Institutional, Onesource Specialty, Parke Davis, Sagent Pharms Inc, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for thiamine hydrochloride. Sixteen suppliers are listed for this compound.

Summary for THIAMINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:20
NDAs:21
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 16
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 87
Patent Applications: 6,823
What excipients (inactive ingredients) are in THIAMINE HYDROCHLORIDE?THIAMINE HYDROCHLORIDE excipients list
DailyMed Link:THIAMINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for THIAMINE HYDROCHLORIDE

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

SponsorPhase
National Institute on Aging (NIA)EARLY_PHASE1
University of California, Los AngelesEARLY_PHASE1
Universiti Sains MalaysiaPHASE2

See all THIAMINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for THIAMINE HYDROCHLORIDE

US Patents and Regulatory Information for THIAMINE 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 THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 083775-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 083534-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Gland THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 217800-001 Feb 24, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Lilly BETALIN S thiamine hydrochloride INJECTABLE;INJECTION 080853-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 080553-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Onesource Specialty THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 217181-001 Oct 29, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
West-ward Pharms Int THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 080575-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Thiamine Hydrochloride

Last updated: January 7, 2026

Executive Summary

Thiamine Hydrochloride, commonly known as Vitamin B1, is a vital nutrient used in clinical medicine and dietary supplements. Its global market is experiencing significant shifts driven by demographic trends, regulatory policies, and technological advances. This report analyzes the key market drivers, competitive landscape, regulatory environment, and financial outlook for Thiamine Hydrochloride, providing a comprehensive understanding for investors and industry stakeholders.


What Are the Market Drivers for Thiamine Hydrochloride?

Rising Incidence of Nutritional Deficiencies

The global prevalence of vitamin deficiencies, including thiamine deficiency, continues to climb due to increasing malnutrition, chronic diseases, and aging populations. According to WHO, micronutrient deficiencies affect over 2 billion people worldwide, emphasizing the importance of supplement-based solutions [1].

Increased Clinical Applications

Thiamine Hydrochloride is essential in treating conditions such as Wernicke’s encephalopathy, beriberi, and alcohol-related neurological disorders. Its role in metabolic support during critical care increases demand in hospital settings. Growth in the healthcare sector, particularly in emerging economies, expands therapeutic applications.

Growing Demand for Dietary Supplements

The global dietary supplements market is projected to grow at a CAGR of 8.9% from 2022-2027, driven by health-conscious consumers and preventive healthcare trends. Thiamine forms a core component of multivitamin and B-complex formulations, with increasing market penetration in North America, Europe, and Asia-Pacific.

Regulatory and Policy Influence

Stringent regulatory standards—such as those by the FDA and EMA—aim to ensure supplement safety, accelerating the demand for high-quality Thiamine Hydrochloride. Policies promoting nutritional interventions in public health further bolster market growth.

Technological Innovations in Production**

Improvements in synthetic and biotechnological manufacturing processes have led to increased efficiency and cost reductions, making Thiamine Hydrochloride more accessible and profitable.


What Is the Current Market Size and Forecast?

Parameter Value/Average Source
2022 Global Market Size $200 million Reports & Market Research [2]
2027 Projected Market Size $340 million Market Analyst Pro [3]
CAGR (2022-2027) 11.4% Industry Reports
Key Regional Markets North America (35%), Europe (25%), Asia-Pacific (30%) Industry Data

Market Breakdown by Application

Application Market Share (2022) Forecast (2027) Notes
Clinical Therapeutics 45% 50% Wernicke’s encephalopathy, critical care
Dietary Supplements 45% 40% Multivitamin formulations, fortified foods
Animal Nutrition 10% 10% Feed additive applications

Who Are the Key Players in the Thiamine Hydrochloride Market?

Company Market Share Product Portfolio Highlights Regions Covered
Merck KGaA 25% USP grade, high-purity synthetic Thiamine Global
BASF SE 20% Ready-to-use formulations, custom packaging North America, Europe
Zhejiang Medicine Co. Ltd 15% Bio-optimized, sustainable manufacturing China, Asia-Pacific
GlaxoSmithKline 10% Pharmaceutical-grade Thiamine Hydrochloride Europe, North America
Others 30% Local manufacturers, niche suppliers Various

What Are the Regulatory Policies Influencing Market Trajectory?

US FDA & European EMA Standards

  • Ensures Good Manufacturing Practices (GMP) for pharmaceutical-grade Thiamine Hydrochloride.
  • Classifies Thiamine as Generally Recognized as Safe (GRAS) for dietary uses.
  • Requires detailed safety and efficacy data for therapeutic applications.

China’s Food and Drug Administration (CFDA)

  • Facilitates widespread use in dietary supplements.
  • Focuses on sustainable production and labeling standards.

International Harmonization Efforts

  • WHO guidelines for micronutrient supplementation.
  • APIs (Active Pharmaceutical Ingredients) producers adhering to ICH guidelines for stability and purity.

What Are the Financial Opportunities and Risks?

Investment Opportunities

  • Expanding Production Capacity: Cost-effective synthetic routes augment profit margins.
  • Vertical Integration: Manufacturers controlling raw material sourcing can optimize supply chains.
  • Innovative Formulations: Development of sustained-release and stabilized Thiamine products can command premium pricing.
  • Emerging Markets: Rapid industrialization and urbanization in Asia-Pacific countries offer significant sales expansion.

Risks and Challenges

  • Price Volatility: Fluctuations in raw materials (e.g., purines used in synthesis) impact profitability.
  • Regulatory Barriers: Stringent approval processes can delay market entry, especially in therapeutics.
  • Market Saturation: Established players may limit new entrants’ growth.
  • Counterfeiting and Quality Control: Low-cost, substandard products threaten brand integrity.
Risk Factor Impact Mitigation Strategies
Raw Material Price Fluctuations Price instability Long-term supply agreements, diversified sourcing
Regulatory Delays Market entry delays Engage with regulators early, compliance audits
Market Saturation Revenue plateau Product innovation, niche markets focus
Supply Chain Disruptions Production impediments Diversified manufacturing hubs

How Does Thiamine Hydrochloride Compare with Alternatives?

Alternatives in B-Vitamin Formulations

Substance Availability Bioavailability Cost Regulatory Status
Synthetic Thiamine Hydrochloride High High Moderate Well-established
Natural Thiamine sources (e.g., yeast extracts) Moderate Variable Higher Approved with natural origin claims
Liposomal or stabilized derivatives Emerging Enhanced Higher Pending regulatory review

Market Positioning

  • Synthetic Thiamine Hydrochloride remains preferred due to consistent purity, cost-effectiveness, and regulatory clarity.

Deep Dive: Key Market Segments & Regional Insights

Regional Market Trends

Region Growth Drivers Challenges Market Share (2022)
North America Established healthcare infrastructure, aging population Regulatory compliance 35%
Europe High supplement consumption, aging demographics Price sensitivity 25%
Asia-Pacific Large population, improving healthcare access Supply chain complexities 30%
Latin America & Africa Emerging markets, nutritional deficiencies Infrastructure development 10%

Segment-Specific Growth

  • Clinical therapeutics: CAGR projected at 9% over 2022-2027, driven by hospitals and critical care units.
  • Dietary supplements: CAGR projected at 12%, fueled by consumer health trends.
  • Animal nutrition: Steady growth, maintaining ~10%, with expanding use in livestock.

Key Takeaways

  • The Thiamine Hydrochloride market is poised for growth driven by demographic trends and increased clinical and supplement use.
  • Regulatory standards favor high-purity products, favoring established manufacturers.
  • Asia-Pacific represents the fastest-growing regional market, offering significant opportunities.
  • Cost-effective manufacturing technologies and product innovation are critical for gaining competitive edge.
  • Supply chain integrity and regulatory compliance remain vital risk mitigants.

FAQs

1. What are the primary therapeutic uses of Thiamine Hydrochloride?
It is primarily used for treating Wernicke’s encephalopathy, beriberi, and as a supportive agent in metabolic disorders.

2. How does regulatory policy affect the market?
Strict GMP standards and approval processes in major markets like the US and EU help ensure product quality but can introduce delays and increase compliance costs.

3. What are the main challenges faced by market participants?
Price fluctuations, regulatory hurdles, market saturation, and quality assurance issues pose ongoing challenges.

4. What future innovations could impact the market?
Development of stabilized formulations, sustained-release tablets, and bioavailable derivatives can open premium-priced segments.

5. Which regions are expected to lead in market growth?
Asia-Pacific will likely dominate growth, followed by North America and Europe, due to demographic trends and healthcare investments.


References

[1] WHO. Micronutrient Deficiencies Overview. 2021.
[2] MarketResearch.com. The Global Vitamin Market Outlook. 2022.
[3] Market Analyst Pro. Thiamine Hydrochloride Market Forecast 2022-2027. 2022.


More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.