Sodium benzoate; sodium phenylacetate - Generic Drug Details

What are the generic sources for sodium benzoate; sodium phenylacetate and what is the scope of patent protection?

Sodium benzoate; sodium phenylacetate is the generic ingredient in three branded drugs marketed by Bausch, Ailex Pharms Llc, Maia Pharms Inc, Navinta Llc, and B Braun, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for sodium benzoate; sodium phenylacetate

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Patent Applications:	2
DailyMed Link:	sodium benzoate; sodium phenylacetate at DailyMed

Recent Clinical Trials for sodium benzoate; sodium phenylacetate

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

Sponsor	Phase
Takeda	Phase 1
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 2
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 1

See all sodium benzoate; sodium phenylacetate clinical trials

Pharmacology for sodium benzoate; sodium phenylacetate

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

Anatomical Therapeutic Chemical (ATC) Classes for sodium benzoate; sodium phenylacetate

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sodium benzoate; sodium phenylacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	215025-001	Jun 10, 2021	AP	RX	Yes	Yes
Navinta Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	205880-001	Aug 4, 2016	AP	RX	No	No
Bausch	AMMONUL	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	020645-001	Feb 17, 2005		DISCN	Yes	No
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987		DISCN	No	No

Expired US Patents for sodium benzoate; sodium phenylacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987

Sodium benzoate; sodium phenylacetate Market Analysis and Financial Projection Experimental

Sodium Benzoate and Sodium Phenylacetate Market Dynamics and Financial Trajectory

Market Overview

Sodium benzoate, a widely used preservative, and sodium phenylacetate, often combined with sodium benzoate in medical applications, are crucial components in various industries. Here’s a detailed look at their market dynamics and financial trajectory.

Market Size and Growth

• The global sodium benzoate market is projected to grow significantly over the next few years. By 2028, the market is expected to reach $0.8 billion, growing at a compound annual growth rate (CAGR) of 5.9% from 2023 to 2028[1].
• Another forecast indicates that the global sodium benzoate market will reach $764.2 million by 2027, growing at a CAGR of 3.7% from 2020 to 2027[2].
• By 2029, the market is anticipated to reach $672.21 million, with a CAGR of 4% during the forecast period from 2023 to 2029[3].

Segmentation

By Type

• The market is segmented into industrial grade, food grade, and pharmaceutical grade. The food grade segment is particularly significant due to the widespread use of sodium benzoate as a preservative in the food and beverage industry[1].

By Form

• Sodium benzoate is available in various forms, including powder, granules, flakes, and other forms. The powder form is commonly used due to its ease of application and high solubility[1].

By Distribution Channel

• The market is segmented into online retailers and offline retailers. Offline retailers dominate the market due to the traditional purchasing habits of consumers, especially in the food and beverage sector[1].

By Application

• Sodium benzoate is used as an antifungal agent, antimicrobial agent, rust and corrosion inhibitor, and preservative. Its preservative properties make it a staple in the food and beverage industry[1].

Drivers of Growth

Economic Growth in APAC

• The Asia-Pacific region is the largest and fastest-growing market for sodium benzoate, driven by economic growth, industrialization, and increasing disposable income in countries like India, China, and Japan[3].

Demand in Food and Beverage Industry

• The increasing demand from the food and beverage industry is a major driver. Sodium benzoate is widely used to inhibit the growth of bacteria, mold, and yeast, ensuring the stability and shelf-life of products[1].

Cosmetics Industry

• The cosmetics industry also drives demand for sodium benzoate as a preservative, contributing to the market's growth. The global cosmetics sector, valued at $228 billion in 2021, continues to grow, boosting the demand for sodium benzoate[1].

Regulatory Approvals and Clean Label Trends

• Regulatory approvals and the trend towards clean labels in food products further support the market's growth. Consumers are increasingly seeking products with fewer and more natural ingredients, which includes the use of sodium benzoate as a preservative[1].

Restraints

Health Concerns

• Despite its benefits, sodium benzoate has some health concerns associated with it. High consumption can be harmful, and some studies suggest it may cause cancer by affecting oxygen cells. These concerns lead to stricter regulations and consumer skepticism, which can restrain market growth[3].

Government Regulations

• Strict government regulations on the use of chemicals in food and cosmetics also act as a restraint. In developed countries like Germany and the U.S., systematic preservatives are often banned due to health concerns, affecting the market[3].

Opportunities

Rising Health Concerns and Medical Applications

• Sodium benzoate has medical applications, such as treating post-dural puncture headache and hyperammonemia diseases. This presents an opportunity for growth in the pharmaceutical sector[3].

Consumer Education and Transparency

• Increasing consumer education on food safety and the demand for allergen-free products create opportunities for sodium benzoate, especially if it is marketed as a safe and natural preservative[1].

Trends

Consumer Awareness on Food Safety

• Consumers are becoming more aware of food safety and are opting for fresh and organic food with minimal chemical preservatives. This trend can impact the market, but sodium benzoate's natural origin and effectiveness can help it maintain its position[3].

Packaging Innovations

• Innovations in packaging that enhance the shelf-life of products without the need for extensive preservatives could influence the market. However, sodium benzoate's versatility and cost-effectiveness make it a likely choice even with these innovations[1].

Regional Insights

Asia-Pacific

• The Asia-Pacific region is the largest and fastest-growing market for sodium benzoate, driven by economic growth and rising disposable income. China is a significant player in this region, expected to grow substantially over the forecast period[3].

North America and Europe

• In North America and Europe, the market is more stable but still growing. The U.S. market, for instance, is estimated at $159.7 million in 2020 and is expected to grow at a moderate rate. Germany and other European countries also contribute significantly to the market, although regulatory restrictions can impact growth[2].

Middle East and Africa

• The Middle East and Africa are also experiencing growth, driven by developing economies and increasing consumer demand for food and beverage products that require preservatives like sodium benzoate[3].

Financial Trajectory for Sodium Phenylacetate

Combined Use with Sodium Benzoate

• Sodium phenylacetate is often used in combination with sodium benzoate in medical applications, such as in the treatment of hyperammonemia. The financial trajectory of this combination is tied to the pharmaceutical market's growth and the specific medical applications where these compounds are used[4].

Regulatory Approvals

• The financial success of sodium phenylacetate and sodium benzoate combinations, such as the injection approved under the 505(b)(2) pathway, depends on regulatory approvals and the stability of the formulations. The FDA's approval and the granting of a biowaiver for these products indicate a positive financial outlook[4].

Key Takeaways

• The global sodium benzoate market is expected to grow significantly, driven by demand from the food and beverage, cosmetics, and pharmaceutical industries.
• Economic growth in the Asia-Pacific region and increasing consumer awareness of food safety are key drivers.
• Health concerns and regulatory restrictions are restraints, but the market's versatility and natural origin of sodium benzoate offer opportunities for growth.
• Sodium phenylacetate, when combined with sodium benzoate, has a promising financial trajectory in the pharmaceutical sector, subject to regulatory approvals and medical demand.

FAQs

What is the expected market size of sodium benzoate by 2028?

The global sodium benzoate market is expected to reach $0.8 billion by 2028, growing at a CAGR of 5.9% from 2023 to 2028[1].

Which region is the largest market for sodium benzoate?

The Asia-Pacific region is the largest and fastest-growing market for sodium benzoate, driven by economic growth and increasing disposable income in countries like India, China, and Japan[3].

What are the primary applications of sodium benzoate?

Sodium benzoate is primarily used as an antifungal agent, antimicrobial agent, rust and corrosion inhibitor, and preservative, especially in the food and beverage industry[1].

How does the cosmetics industry impact the sodium benzoate market?

The cosmetics industry drives demand for sodium benzoate as a preservative, contributing to the market's growth. The global cosmetics sector's valuation and growth support this demand[1].

What are the health concerns associated with sodium benzoate?

High consumption of sodium benzoate can be harmful, and some studies suggest it may cause cancer by affecting oxygen cells. These concerns lead to stricter regulations and consumer skepticism[3].

Sources

1. The Business Research Company, "Global Sodium Benzoate Market Report 2024".
2. Business Wire, "Global Sodium Benzoate Industry (2020 to 2027) - Market Trajectory & Analytics".
3. Maximize Market Research, "Sodium Benzoate Market - Analysis and Forecast (2023-2029)".
4. FDA, "Center for Drug Evaluation and Research - Sodium Phenylacetate and Sodium Benzoate Injection".