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
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
Navinta Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	217526-001	Jul 14, 2023	AP	RX	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

Market Dynamics and Financial Trajectory for Sodium Benzoate and Sodium Phenylacetate

Last updated: February 19, 2026

What are the market sizes and key drivers for sodium benzoate and sodium phenylacetate?

Sodium benzoate and sodium phenylacetate are chemical compounds with distinct applications, primarily in food preservation and pharmaceutical treatments, respectively. Their markets are shaped by regulatory frameworks, acceptance levels, manufacturing costs, and therapeutic demand.

Sodium Benzoate Market Overview

• Market size: Estimated global market value was approximately USD 125 million in 2022, with a Compound Annual Growth Rate (CAGR) of 4.2% forecasted through 2030.
• Applications: Predominantly used as a food preservative (E211), especially in acidic foods and beverages, including soft drinks, fruit products, and condiments.
• Key drivers:
  • Growing demand for natural preservatives
  • Increased global consumption of processed foods
  • Stricter regulations limiting artificial preservatives, leading to reliance on approved agents like sodium benzoate

Sodium Phenylacetate Market Overview

• Market size: Niche with a valuation of around USD 50 million in 2022; expected to grow at a CAGR of 4.8% until 2030.
• Applications: Primarily used in treating urea cycle disorders (UCDs) and certain cancers, often supplied through specialized pharmaceutical formulations.
• Key drivers:
  • Advances in metabolic disorder treatments
  • Growing demand for targeted cancer therapies
  • Regulatory approval for specific indications

What regulatory factors influence market prospects?

Sodium Benzoate

• Recognized as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA) with acceptable daily intake (ADI) of 5 mg/kg body weight.
• European Union permits sodium benzoate as a food additive (E211), with maximum permissible levels varying by product.
• Rising concerns over potential carcinogenicity at high concentrations limit usage, prompting innovation in natural preservatives.

Sodium Phenylacetate

• FDA-approved for use in treating hyperammonemia and in clinical trials for cancer treatments.
• The drug is classified as an orphan drug for several conditions, which provides regulatory incentives such as exclusivity periods.
• Ongoing research expands potential indications, potentially influencing regulatory status and market size.

How do manufacturing costs and supply chain factors impact the financial outlook?

Sodium Benzoate

• Cost factors: Raw benzene (derivable from petrochemical sources), energy prices, and purification processes.
• Manufacturing cost estimates: USD 0.80–1.20/kg for bulk production.
• Supply chain: Sensitive to fluctuations in petrochemical supply, geopolitical stability, and environmental regulations.

Sodium Phenylacetate

• Cost factors: Complex synthesis involving phenylacetic acid, which depends on pharmaceutical-grade raw materials and multi-step chemical processes.
• Manufacturing cost estimates: USD 20–40 per gram of finished API (Active Pharmaceutical Ingredient).
• Supply chain: Limited suppliers due to specialized manufacturing, potential bottlenecks impact pricing and availability.

What are the investment and R&D trends?

• Sodium Benzoate: R&D focuses on natural and clean-label preservative alternatives. Investments in bio-based production processes are emerging, aiming to reduce dependence on petrochemicals.
• Sodium Phenylacetate: Focus on expanding clinical indications, improving pharmacokinetics, and developing combination therapies. Collaboration between biotech firms and pharmaceutical companies accelerates development pipelines.

How does competitive positioning shift for these compounds?

Compound	Key Industry Players	Market Share (Estimated 2022)	Innovation Trends
Sodium Benzoate	Eastman Chemical, Kenso Corporation, Hanwha Chemical	40-45%	Natural preservatives, bio-based production processes
Sodium Phenylacetate	Shire (a Takeda company), Novartis, Specialized pharmaceutical firms	20-25%	Novel drug delivery systems, combination therapies

Emerging entrants with sustainable production methods and novel applications threaten incumbents' dominance.

What are the key risks and opportunities?

Risks

• Regulatory scrutiny, especially concerning preservative safety.
• Supply chain disruptions, notably in raw material sourcing.
• Market saturation in food applications for sodium benzoate.
• Clinical trial failures or regulatory delays impacting sodium phenylacetate.

Opportunities

• Expanding applications for sodium phenylacetate in oncology and metabolic disorders.
• Natural preservative innovations decreasing reliance on synthetic agents.
• Geographic expansion in emerging markets with rising food and healthcare demands.
• Process innovation to decrease manufacturing costs and environmental impact.

Key Takeaways

• The sodium benzoate market benefits from steady growth driven by processed food demand and regulatory acceptance but faces regulatory and consumer pushback against synthetic preservatives.
• Sodium phenylacetate's niche pharmaceutical applications position it for growth linked to advances in metabolic and cancer therapies.
• Manufacturing costs and supply chain stability play crucial roles in financial trajectories.
• Patent statuses, regulatory pathways, and clinical development pipelines shape future market dynamics.
• Innovation in natural preservatives and drug delivery will influence competitiveness and growth potential.

FAQs

1. What factors constrain sodium benzoate's market growth?
Consumer health concerns and regulatory limitations influence the market, especially as demand shifts toward natural preservatives.

2. How is sodium phenylacetate positioned in the pharmaceutical industry?
It remains a niche treatment for urea cycle disorders and investigational cancer therapy, with growth driven by expanding clinical applications.

3. What are the primary raw material risks for these compounds?
Petrochemical price volatility and supply chain disruptions for benzene and phenylacetic acid impact manufacturing costs and availability.

4. How do regulatory approvals affect market opportunities?
FDA and EU approvals facilitate market entry; orphan drug designations and clinical trial advancements enable faster commercialization for sodium phenylacetate.

5. What are the prospects for sustainable production?
Bio-based processes for sodium benzoate are emerging, driven by demand for natural and environmentally friendly products.

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References

[1] Grand View Research. (2023). Sodium benzoate Market Size, Share & Trends Analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/sodium-benzoate-market

[2] Market Data Forecast. (2023). Global Sodium Phenylacetate Market. Retrieved from https://www.marketdataforecast.com/market-reports/sodium-phenylacetate-market

[3] U.S. Food and Drug Administration. (2022). Food Additive Status List. Retrieved from https://www.fda.gov/food/food-ingredients-packaging/food-additive-status-list

[4] European Food Safety Authority. (2022). Scientific Opinion on the safety of sodium benzoate (E211). EFSA Journal, 20(5), 7023.

[5] European Medicines Agency. (2023). Orphan designation for sodium phenylacetate. Retrieved from https://www.ema.europa.eu/en/medicines/human/orphan-designations

[6] Bloomberg Intelligence. (2023). Chemical industry outlook.