VALPROIC ACID - Generic Drug Details

What are the generic sources for valproic acid and what is the scope of freedom to operate?

Valproic acid is the generic ingredient in three branded drugs marketed by Bionpharma, Abbvie, Catalent, Hibrow Hlthcare, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Upsher Smith Labs, Ani Pharms, Chartwell Rx, Hikma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Pharmobedient Cnsltg, and Quagen, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for valproic acid. Seventeen suppliers are listed for this compound.

Summary for VALPROIC ACID

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	189
Patent Applications:	7,168
Drug Prices:	Drug price trends for VALPROIC ACID
What excipients (inactive ingredients) are in VALPROIC ACID?	VALPROIC ACID excipients list
DailyMed Link:	VALPROIC ACID at DailyMed

See drug prices for VALPROIC ACID

Recent Clinical Trials for VALPROIC ACID

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

Sponsor	Phase
Sohag University	Phase 2/Phase 3
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4

See all VALPROIC ACID clinical trials

Pharmacology for VALPROIC ACID

Drug Class	Anti-epileptic Agent Mood Stabilizer
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for VALPROIC ACID

Anticonvulsants

Antimanic Agents

Enzyme Inhibitors

GABA Agents

Anatomical Therapeutic Chemical (ATC) Classes for VALPROIC ACID

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for VALPROIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	VALPROIC ACID	valproic acid	SYRUP;ORAL	074060-001	Jan 13, 1995		DISCN	No	No
Chartwell Rx	VALPROIC ACID	valproic acid	SYRUP;ORAL	075782-001	Dec 22, 2000	AA	RX	No	No
Abbvie	DEPAKENE	valproic acid	CAPSULE;ORAL	018081-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ani Pharms	VALPROIC ACID	valproic acid	SYRUP;ORAL	073178-001	Aug 25, 1992	AA	RX	No	No

VALPROIC ACID Market Analysis and Financial Projection Experimental

Valproic Acid Market Dynamics and Financial Trajectory

Market Overview

The valproic acid market is experiencing significant growth, driven by several key factors including its versatile applications, cost-effectiveness, and the ongoing trend of drug repurposing.

Market Growth and Projections

The valproic acid market has seen considerable expansion in recent years and is expected to continue this trend. Analysts predict substantial market size increases between 2024 and 2031, with the global market valued to expand at a notable CAGR[1][4].

Key Drivers

Therapeutic Applications

Valproic acid is widely used as an antiepileptic drug and also has applications in treating bipolar disorder, major depressive disorder, and for the prevention of migraine headaches. Its effectiveness in these therapeutic areas contributes significantly to its market growth[2][5].

Cost-Effectiveness

Replacing divalproex sodium with valproic acid has been shown to be economically advantageous, with a 56% decrease in total direct costs observed in one study. This cost-effectiveness is a major driver for its adoption[2].

Drug Repurposing

Valproic acid is a prime example of a drug that has been repurposed. The drug repurposing market, which includes valproic acid, is expected to grow at a CAGR of 4.5% from 2024 to 2033, reaching a market size of USD 51.8 billion by 2033. This trend highlights the potential for valproic acid to be used in new therapeutic areas, further boosting its market[3].

Market Competition

Key Players

The valproic acid market is competitive, with several key players such as Sun Pharmaceutical Industries, Anjan Drug, The Nippon Synthetic Chemical Industry, Katwijk Chemie BV, PCAS, Sanofi Chimie, Assurgen Pharma, and Harman Finochem. These companies are profiled in market reports, which also include their market shares, product portfolios, and growth prospects[1].

Regional Analysis

The market is geographically fragmented, with North America being a dominant region due to heightened research and development activities focused on drug repurposing. The Asia Pacific region is also poised for significant growth, driven by increasing demand and research initiatives[1][3].

Economic Impact

Global and Chinese Macroeconomic Environment

The global and Chinese macroeconomic environments play a crucial role in the valproic acid market. Factors such as economic growth, unemployment rates, and overall market conditions influence the demand and supply of valproic acid. A stable macroeconomic environment is expected to support the market's growth[4].

Cost and Profit Estimation

Market reports provide detailed cost and profit estimations for the valproic acid market. These include production costs, market share, and revenue generated by key players. The reports also analyze the supply and consumption patterns, import and export status, and the overall industry chain structure[4].

Manufacturing and Supply Chain

Manufacturing Processes

The manufacturing process of valproic acid involves several stages, including raw material sourcing, production, and quality control. Market reports offer insights into the manufacturing processes, cost analysis, and rates of consumption and production[1][4].

Supply Chain Assessment

The supply chain assessment is critical for understanding the market dynamics. This includes evaluating the raw materials, production capacity, and distribution networks. A robust supply chain ensures consistent supply and meets the growing demand for valproic acid[1].

Regulatory Framework

Guidelines and Regulations

The valproic acid market is subject to various regulatory frameworks and guidelines. Market reports highlight the regulatory environment, which is essential for manufacturers and stakeholders to navigate the market effectively[1][4].

Consumer Preferences and Behavior

Inclination in Consumer Preferences

The market insights indicate a shift in consumer preferences towards cost-effective and efficient treatments. Valproic acid, being a cost-effective alternative, aligns well with these preferences, contributing to its market growth[1].

Challenges and Opportunities

Industry Development Challenges

Despite the growth, the valproic acid market faces challenges such as intense competition, regulatory hurdles, and the need for continuous innovation. Addressing these challenges is crucial for maintaining a competitive edge[4].

Industry Development Opportunities

The market also presents several opportunities, including the potential for new therapeutic applications, expansion into new geographies, and strategic collaborations. These opportunities can help stakeholders to further grow their business in the valproic acid market[4].

SWOT Analysis

Strengths, Weaknesses, Opportunities, and Threats

A SWOT analysis of key market players helps in understanding their internal and external environments. This analysis is essential for identifying the strengths, weaknesses, opportunities, and threats that could impact the growth of the industry[1].

Financial Trajectory

Revenue and Market Size

The valproic acid market is projected to achieve significant revenue growth, driven by increasing demand and new applications. The market size is expected to expand substantially between 2024 and 2031, making it a lucrative segment for investors and stakeholders[1][4].

Cost Savings and Economic Benefits

The economic benefits of using valproic acid, such as the 56% decrease in total direct costs observed in one study, make it an attractive option for both patients and healthcare providers. This cost-effectiveness contributes to its financial trajectory and market appeal[2].

Key Takeaways

• The valproic acid market is experiencing significant growth driven by its therapeutic applications, cost-effectiveness, and the trend of drug repurposing.
• Key players in the market include Sun Pharmaceutical Industries, Anjan Drug, and others, with North America being a dominant region.
• The market is influenced by global and Chinese macroeconomic environments and is subject to various regulatory frameworks.
• Consumer preferences towards cost-effective treatments and the potential for new therapeutic applications present opportunities for growth.
• A SWOT analysis helps in understanding the strengths, weaknesses, opportunities, and threats of key market players.

FAQs

1. What are the primary therapeutic applications of valproic acid?

Valproic acid is primarily used as an antiepileptic drug and also has applications in treating bipolar disorder, major depressive disorder, and for the prevention of migraine headaches[2][5].

2. How does the cost of valproic acid compare to divalproex sodium?

The cost difference between valproic acid and divalproex sodium can be small, but over time, it can add up to a significant amount. Replacing divalproex sodium with valproic acid has been shown to be economically advantageous[2][5].

3. What is the projected market size of the valproic acid market by 2031?

The valproic acid market is expected to achieve significant growth, with substantial market size increases predicted between 2024 and 2031. However, exact figures vary by report[1][4].

4. Which regions are dominant in the valproic acid market?

North America is currently the dominant region in the valproic acid market, driven by heightened research and development activities. The Asia Pacific region is also expected to show significant growth[1][3].

5. What are the key factors influencing the supply chain of valproic acid?

The supply chain of valproic acid is influenced by factors such as raw material sourcing, production capacity, distribution networks, and regulatory environments. A robust supply chain is crucial for meeting the growing demand[1][4].

Cited Sources:

1. Market Research Pulse: Valproic Acid Market Trends, Scope And Outlook[1]
2. PubMed: Clinical and economic impact of replacing divalproex sodium with valproic acid[2]
3. Market.US: Drug Repurposing Market Outlook, Assessment | CAGR of 4.5%[3]
4. Prof-Research: Valproic Acid Market Size, Share, Trend and Forecast to 2025[4]
5. Medical News Today: Valproic acid cost 2024: Coupons and more[5]