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SODIUM PHENYLACETATE AND SODIUM BENZOATE Drug Patent Profile

When do Sodium Phenylacetate And Sodium Benzoate patents expire, and when can generic versions of Sodium Phenylacetate And Sodium Benzoate launch?

Sodium Phenylacetate And Sodium Benzoate is a drug marketed by Ailex Pharms Llc, Maia Pharms Inc, and Navinta Llc. and is included in five NDAs.

The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.

Summary for SODIUM PHENYLACETATE AND SODIUM BENZOATE

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
Patent Applications:	1
What excipients (inactive ingredients) are in SODIUM PHENYLACETATE AND SODIUM BENZOATE?	SODIUM PHENYLACETATE AND SODIUM BENZOATE excipients list
DailyMed Link:	SODIUM PHENYLACETATE AND SODIUM BENZOATE at DailyMed

Recent Clinical Trials for SODIUM PHENYLACETATE AND SODIUM BENZOATE

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 PHENYLACETATE AND SODIUM BENZOATE clinical trials

Pharmacology for SODIUM PHENYLACETATE AND SODIUM BENZOATE

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

US Patents and Regulatory Information for SODIUM PHENYLACETATE AND SODIUM BENZOATE

SODIUM PHENYLACETATE AND SODIUM BENZOATE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096-001	Feb 24, 2016	AP	RX	No	Yes
Navinta Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	205880-001	Aug 4, 2016	AP	RX	No	No
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	208521-001	May 8, 2017	AP	RX	No	No

SODIUM PHENYLACETATE AND SODIUM BENZOATE Market Analysis and Financial Projection Experimental

Sodium Benzoate and Sodium Phenylacetate: Market Dynamics and Financial Trajectory

Market Overview

The market for sodium benzoate and, to a lesser extent, sodium phenylacetate, is driven by several key factors, including food safety regulations, consumer demand for quality products, and expanding applications in various industries.

Sodium Benzoate Market

• The sodium benzoate market is projected to reach USD 2.3 billion by 2032, growing at a compound annual growth rate (CAGR) of 6.4% from 2024 to 2032. This growth is largely attributed to the global focus on food safety and quality, as well as the increasing demand for preservatives in the food and beverage industry[1].
• In 2023, the market size was estimated at USD 1.3 billion, indicating a significant upward trend[1].

Applications and Segments

Food and Beverage Industry

• Sodium benzoate is widely used as a preservative to prevent the growth of harmful bacteria and fungi, thereby extending the shelf life of food products. The food and beverage sector is a major driver of this market, with the segment expected to record a CAGR of 3.7% over certain analysis periods[2][4].

Pharmaceuticals and Personal Care

• Beyond food preservation, sodium benzoate also finds applications in the pharmaceutical and personal care industries. It is used as a brittleness inhibitor in hair sprays, gels, and nail care products, as well as in mouthwashes and deodorants. These segments are experiencing increased growth, particularly in developing countries[1][4].

Medical Applications

• Sodium phenylacetate, often used in conjunction with sodium benzoate, is crucial in the treatment of urea-cycle disorders. The combination of these two compounds has been shown to lower plasma ammonium levels and improve survival rates in patients with these disorders[5].

Regional Insights

Europe

• Europe holds the largest market share for sodium benzoate, with approximately 41.5% of the global market in 2023. This dominance is due to stringent food safety regulations and high consumer awareness about product safety in European countries such as Germany, France, and the UK[1].

Asia-Pacific and Latin America

• The increasing disposable incomes and urbanization in these regions are driving the demand for processed and convenience foods, which in turn increases the demand for preservatives like sodium benzoate. Companies are capitalizing on this growing demand by expanding their production capacities in these regions[1].

United States and China

• The U.S. market for sodium benzoate was estimated at USD 159.7 million in 2020, while China is forecast to grow at a CAGR of 6.7% over the analysis period 2020-2027, reaching a projected market size of USD 161.1 million by 2027[2].

Market Trends and Drivers

Consumer Demand for Safe and Quality Products

• The increasing consumer awareness about food safety and the demand for clean labeling and natural ingredients are significant drivers of the sodium benzoate market. Companies like BASF have launched new product lines emphasizing clean labeling and safety to cater to this demand[1].

Expansion of the Cosmetics Market

• The growth of the cosmetics market, particularly in developing countries, is also driving the demand for sodium benzoate in personal care products[1].

Regulatory Support

• Stringent food safety regulations in regions like Europe support the use of sodium benzoate as a safe and effective preservative, contributing to market growth[1].

Financial Trajectory

Current Market Size and Growth

• The sodium benzoate market is expected to grow from USD 1.3 billion in 2023 to USD 2.3 billion by 2032, with a CAGR of 6.4%[1].
• In the shorter term, the market is projected to grow from USD 0.61 billion in 2023 to USD 0.64 billion in 2024 at a CAGR of 5.3%, and further to USD 0.8 billion by 2028 at a CAGR of 5.9%[4].

Segment-Specific Growth

• The food and beverages segment is expected to record a CAGR of 3.7% over certain analysis periods, while the pharmaceuticals segment is readjusted to a revised 4.4% CAGR for the next 7-year period[2].

Recent Developments

Product Innovations

• Companies like BASF have launched new lines of sodium benzoate products tailored for the food and beverage industry, focusing on clean labeling and safety[1].

Production Capacity Expansion

• Shandong Xinhua Pharmaceutical Co., Ltd. expanded its production capacity in the Asia-Pacific region to meet the increasing demand for sodium benzoate, particularly in the food and beverage sector[1].

Key Takeaways

• The sodium benzoate market is driven by global food safety regulations, consumer demand for quality products, and expanding applications in various industries.
• Europe leads the market due to stringent food safety regulations and high consumer awareness.
• The Asia-Pacific and Latin America regions offer significant growth opportunities due to increasing disposable incomes and urbanization.
• The market is expected to reach USD 2.3 billion by 2032, growing at a CAGR of 6.4%.
• Sodium phenylacetate, used in medical treatments, plays a crucial role in managing urea-cycle disorders.

FAQs

Q: What is the projected market size of the sodium benzoate market by 2032?

A: The sodium benzoate market is projected to reach USD 2.3 billion by 2032[1].

Q: What are the primary drivers of the sodium benzoate market?

A: The primary drivers include global focus on food safety and quality, increasing demand for preservatives in the food and beverage industry, and expanding applications in pharmaceuticals and personal care[1][4].

Q: Which region holds the largest market share for sodium benzoate?

A: Europe holds the largest market share, with approximately 41.5% of the global market in 2023[1].

Q: How is sodium phenylacetate used medically?

A: Sodium phenylacetate is used in conjunction with sodium benzoate to treat urea-cycle disorders by lowering plasma ammonium levels and improving survival rates[5].

Q: What are some recent developments in the sodium benzoate market?

A: Recent developments include product innovations focusing on clean labeling and safety, and the expansion of production capacities in emerging markets[1].