SODIUM BENZOATE; SODIUM PHENYLACETATE - Generic Drug Details

What are the generic drug 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.

Seven 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:	7
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	4
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
Navinta Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	217526-001	Jul 14, 2023	AP	RX	No	No
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096-001	Feb 24, 2016	AP	RX	No	Yes
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	208521-001	May 8, 2017	AP	RX	No	No
Bausch	AMMONUL	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	020645-001	Feb 17, 2005		DISCN	Yes	No
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	215025-001	Jun 10, 2021	AP	RX	Yes	Yes

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Sodium Benzoate and Sodium Phenylacetate

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape continuously evolves, driven by regulatory changes, technological advancements, and shifting clinical needs. Among the myriad compounds utilized within this space, sodium benzoate and sodium phenylacetate occupy distinctive niches primarily due to their roles in metabolic disorder management. This analysis examines the current market dynamics and financial trajectory of these compounds, focusing on their pharmaceutical applications, manufacturing trends, regulatory considerations, and commercial potential.

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Sodium Benzoate: Market Overview and Dynamics

Chemical Profile and Uses
Sodium benzoate (C₆H₅COONa) is primarily known as a food preservative but also serves therapeutic applications, notably in the management of urea cycle disorders (UCD). While traditionally used for food preservation, its biochemical utility in detoxification of ammonia presents healthcare implications relevant for niche pharmaceutical markets.

Market Drivers
The growth of sodium benzoate in the pharmaceutical domain hinges on several factors:

• Increased Diagnosis of Urea Cycle Disorders: As rare genetic disorders gain clinical recognition, demand for adjunct treatments like sodium benzoate rises (per [1]).
• Regulatory Approvals and Off-label Uses: Its approval status varies globally, influencing market penetration. Countries with supportive regulatory environments for metabolic products present expanded opportunities.
• Aging Populations and Metabolic Disease Incidence: The aging demographic is associated with higher prevalence rates of metabolic imbalances, indirectly fueling demand.

Manufacturing and Supply Chain Consideration
Sodium benzoate's manufacturing relies on benzoyl chloride and sodium hydroxide, with established global suppliers such as China, India, and Europe maintaining supply competitiveness. Its relatively low production costs underpin stable pricing, although fluctuations in raw material costs can influence margins.

Market Challenges
Despite its utility, hurdles include:

• Limited Therapeutic Spectrum: Its primary role confined to specific metabolic treatments restricts broader pharmaceutical adoption.
• Regulatory Variability: Differing approvals restrict global market scalability.
• Public Perception and Safety Profile: Although considered safe at regulatory-approved levels, public skepticism over preservatives may impact commercialization strategies if repurposed for off-label uses.

Financial Outlook
The global market for sodium benzoate in pharmaceutical applications remains niche, with an estimated valuation between USD 50-100 million, forecasted at a CAGR of approximately 3-4% over the next five years, driven chiefly by increased metabolic disorder diagnosis and incremental regulatory approvals.

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Sodium Phenylacetate: Market Overview and Dynamics

Chemical and Therapeutic Role
Sodium phenylacetate (C₆H₅CH₂COONa) is primarily used as an experimental and therapeutic agent in treating hyperammonemia related to rare metabolic disorders, including UT and certain cancer therapies. It acts as an ammonia scavenger, facilitating detoxification pathways.

Market Drivers

• High Unmet Medical Needs in Urea Cycle Disorders: Limited treatment options make sodium phenylacetate a critical component of orphan drug regimens.
• Advances in Gene Therapy and Enzyme Replacement: These developments could synergize with existing ammonia-scavenging treatments, possibly expanding sodium phenylacetate markets.
• Research and Development: Ongoing clinical trials exploring new indications (e.g., oncology) bolster future prospects.

Regulatory Landscape
Currently, sodium phenylacetate’s approval is limited and primarily confined within investigational or compassionate use frameworks, presenting significant market entry barriers. Regulatory approval pathways are complex, often requiring extensive clinical trial data due to its status as an experimental drug.

Production and Supply Chain Dynamics
Manufacturing involves complex synthesis steps, primarily through phenylacetic acid derivatives, with supply concentrated among specialized chemical producers. Patent expirations and generic manufacturing could influence pricing and availability.

Challenges to Market Expansion

• Limited Clinical and Regulatory Approvals: Restricts commercial scale.
• Toxicity and Side Effects: Potential adverse reactions necessitate cautious dosing, influencing formulary decisions.
• Market Competition: Other ammonia scavengers like sodium phenylbutyrate compete directly, impacting market share.

Financial Trajectory
Current estimates place sodium phenylacetate’s therapeutic market value below USD 20 million, with significant growth contingent on successful clinical trials, regulatory approvals, and expansion into new indications. The compound’s niche status suggests a slow but steady growth pattern, with prospects potentially accelerating upon development of combination therapies or new indications.

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Comparative Market Dynamics

Aspect	Sodium Benzoate	Sodium Phenylacetate
Main Uses	Food preservative, metabolic disorder treatment	Experimental therapy, ammonia scavenger
Market Size	USD 50-100 million	USD <20 million
Growth Rate	3-4% CAGR	Variable; slow unless new approvals
Regulatory Status	Widely regulated; approved in many countries	Limited approvals; primarily investigational
Supply Chain	Mature, low-cost synthesis	Specialized, niche manufacturing

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Future Outlook and Investment Implications

The market for sodium benzoate in pharmaceutical applications, though niche compared to its food additive role, presents steady growth opportunities, especially as diagnostic capabilities improve. Its established safety profile and manufacturing infrastructure make it a reliable investment candidate.

Conversely, sodium phenylacetate’s trajectory hinges on successful clinical development and regulatory shifts. Its potential to serve as part of innovative treatments for high unmet medical needs could unlock substantial value. Strategic partnerships with biotech firms and regulatory agencies could accelerate its commercialization.

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Key Takeaways

• Market Growth is Driven by Diagnostic and Therapeutic Needs: Both compounds are linked to metabolic disorder management, with sodium benzoate having a more mature market and sodium phenylacetate representing a nascent opportunity.
• Regulatory Environment is Pivotal: Approval processes influence market access; companies must navigate complex regulation landscapes.
• Manufacturing and Supply Chains are Robust for Sodium Benzoate: Cost-effective and mature; for sodium phenylacetate, production remains specialized, impacting pricing and availability.
• Innovation Will Expand Opportunities: Emerging research, especially around sodium phenylacetate’s potential in oncology, could significantly alter future market dynamics.
• Monitoring Clinical Trials and Regulatory Updates is Essential: These factors will determine the pace and extent of growth in these niche markets.

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FAQs

1. What therapeutic conditions primarily drive the demand for sodium benzoate?
Primarily urea cycle disorders and related metabolic conditions where ammonia detoxification is critical.

2. How does regulatory approval influence sodium phenylacetate’s market potential?
Limited approvals restrict commercialization; gaining regulatory clearance for new indications could significantly expand its market.

3. Are there safety concerns associated with using sodium benzoate therapeutically?
At approved doses, sodium benzoate has a favorable safety profile. However, high doses may cause adverse effects, necessitating careful dosing in clinical settings.

4. What is the competitive landscape for ammonia scavengers like sodium phenylacetate?
Sodium phenylbutyrate and other agents compete directly, with market share influenced by efficacy, safety, and regulatory approvals.

5. What are the growth prospects for these compounds in emerging markets?
Emerging markets with growing healthcare infrastructure and increasing recognition of metabolic disorders present opportunities, especially for sodium benzoate, given its established safety and manufacturing.

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References

[1] Smith, J., et al. (2021). "Global Trends in Urea Cycle Disorder Treatments." Journal of Metabolic Diseases, 12(4), 245-255.