THIAMINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Thiamine Hydrochloride, and when can generic versions of Thiamine Hydrochloride launch?

Thiamine Hydrochloride is a drug marketed by Abraxis Pharm, Aspiro, Bel Mar, Caplin, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Luitpold, Mylan Institutional, Parke Davis, Sagent Pharms Inc, Steriscience Speclts, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst. and is included in nineteen NDAs.

The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Thiamine Hydrochloride

A generic version of THIAMINE HYDROCHLORIDE was approved as thiamine hydrochloride by WEST-WARD PHARMS INT on December 31^st, 1969.

Summary for THIAMINE HYDROCHLORIDE

US Patents:	0
Applicants:	18
NDAs:	19
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	83
Patent Applications:	3,627
DailyMed Link:	THIAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for THIAMINE HYDROCHLORIDE

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

Sponsor	Phase
Population Health Research Institute	Phase 3
Canadian Institutes of Health Research (CIHR)	Phase 3
Hamilton Health Sciences Corporation	Phase 3

See all THIAMINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for THIAMINE HYDROCHLORIDE

Vitamin B Complex

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
Hospira	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	040079-001	May 3, 1996		DISCN	No	No
Abraxis Pharm	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	080509-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Dr Reddys	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	080571-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
West-ward Pharms Int	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	080575-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Bel Mar	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	080712-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	083534-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Thiamine Hydrochloride

Introduction

Thiamine hydrochloride, a vital form of vitamin B1, is a crucial micronutrient with a wide range of applications in the food, beverage, pharmaceutical, and animal feed industries. The market for thiamine is experiencing significant growth, driven by various factors including increasing demand for fortified foods, rising awareness of nutritional deficiencies, and expanding uses in health and wellness.

Market Size and Growth Projections

The global thiamine market is anticipated to witness substantial growth over the coming years. As of 2024, the market size is estimated to be around USD 1,238.2 million and is projected to reach USD 2,497 million by 2034, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during this period[1].

Regional Dynamics

North America is expected to play a significant role in the global thiamine market, accounting for around 25% of the global value share. This is largely due to the well-established food and beverage industry in the United States, where the Food and Drug Administration (FDA) mandates the fortification of staple foods like bread and cereals with essential vitamins, including thiamine[1].

South Asia is also set to record a dominant CAGR of 12.2% through 2034, indicating a rapid growth trajectory in this region[1].

Product Types and Preferences

Thiamine mononitrate is anticipated to be the leading product type, showcasing a high CAGR of 7.5% during the forecast period. Its high stability and solubility make it a preferred choice for inclusion in dietary supplements and fortified foods, ensuring prolonged shelf life and consistent potency[1].

End-Use Segmentation

The thiamine market is segmented into several end-use categories:

• Food and Beverages: This segment includes fortified cereals and nutritional supplements. The mandatory fortification of staple foods in many countries drives significant demand here.
• Animal Feed: This includes livestock feed, pet food, and aquaculture feed. Thiamine is essential for the health and development of animals.
• Pharmaceuticals: Thiamine hydrochloride is used in various pharmaceutical formulations, including treatments for conditions caused by vitamin B1 deficiency.
• Personal Care: Skincare and hair care products also utilize thiamine for its nutritional benefits[1].

Drivers of Growth

Several factors are driving the growth of the thiamine market:

• Increasing Demand for Fortified Foods: The need to combat nutritional deficiencies has led to a surge in the demand for fortified foods, which is a key driver for thiamine sales[1].
• Rising Cases of Beriberi and Wernicke-Korsakoff Syndrome: These conditions, caused by severe vitamin B1 deficiency, are increasing the demand for thiamine[1].
• Expanding Use in Mental Health: Thiamine's role in mental health, beyond just physical health, is also driving market growth[3].
• Energy Metabolism and Cell Growth: The product's importance in energy metabolism and the development and growth of healthy cells further boosts demand[3][4].

Challenges and Limitations

Despite the positive growth trajectory, there are some challenges:

• Lack of Awareness: Limited public awareness about thiamine deficiency can hinder market growth.
• Health Issues: The shortage of thiamine can lead to serious health issues, which may also impact market dynamics[3].

Competitive Landscape

The thiamine market is characterized by a few key players who dominate the market:

• DSM Nutritional Products
• BASF SE
• Lonza Group
• Archer Daniels Midland Company (ADM)
• Jiangsu Jubang Pharmaceutical Co. Ltd

These companies are engaged in various strategic actions such as research programs, price adjustments, and expansion initiatives to maintain their market positions[1][3].

Recent Developments and Innovations

Recent developments include:

• Product Launches: Companies like Hikma Pharmaceuticals have introduced new thiamine hydrochloride injection products, expanding the market offerings[3].
• Regulatory Approvals: The US FDA has approved new thiamine products, such as Aurobindo Pharma Limited's Thiamine HCl Injection[3].

Financial Performance and Projections

The financial performance of the thiamine market is robust:

• Revenue Growth: The market is expected to grow from USD 1,166.2 million in 2023 to USD 2,497 million by 2034, with a CAGR of 7.3%[1].
• Segmental Growth: The pharmaceutical segment is expected to register a high growth rate due to its increasing use as an immunity booster and promoter of natural growth and development[4].

Key Takeaways

• The thiamine market is projected to grow significantly, driven by increasing demand for fortified foods and rising awareness of nutritional deficiencies.
• North America and South Asia are key regions driving market growth.
• Thiamine mononitrate is the preferred product type due to its stability and solubility.
• The market faces challenges such as lack of awareness and health issues related to thiamine deficiency.

FAQs

Q: What is the projected market size of the thiamine market by 2034? A: The global thiamine market is projected to reach USD 2,497 million by 2034[1].

Q: Which region is expected to dominate the thiamine market growth? A: South Asia is set to record the dominant CAGR of 12.2% through 2034[1].

Q: What are the primary drivers of the thiamine market growth? A: The primary drivers include increasing demand for fortified foods, rising cases of Beriberi and Wernicke-Korsakoff syndrome, and expanding use in mental health and energy metabolism[1][3].

Q: Which product type is anticipated to lead the market? A: Thiamine mononitrate is expected to be the leading product type due to its high stability and solubility[1].

Q: What are the key segments of the thiamine market? A: The key segments include food and beverages, animal feed, pharmaceuticals, and personal care[1].

Citations

1. Future Market Insights, Thiamine Market Size, Share, Demand & Forecast to 2034.
2. NYAS Publications, Thiamine fortification strategies in low‐ and middle‐income settings.
3. GlobeNewswire, Thiamine Market is slated to Witness Tremendous Revenue Growth of US$ 715.32 Mn by 2032.
4. Grand View Research, Thiamine Market Size Worth $549.9 Million By 2030.