Last Updated: June 17, 2026

SODIUM P.A.S. Drug Patent Profile


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When do Sodium P.a.s. patents expire, and what generic alternatives are available?

Sodium P.a.s. is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in SODIUM P.A.S. is aminosalicylate sodium. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium profile page.

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Summary for SODIUM P.A.S.
Recent Clinical Trials for SODIUM P.A.S.

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

SponsorPhase
Nextrast, Inc.PHASE1
Eurofarma Laboratorios S.A.PHASE3
Yung NAPHASE2

See all SODIUM P.A.S. clinical trials

US Patents and Regulatory Information for SODIUM P.A.S.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett SODIUM P.A.S. aminosalicylate sodium TABLET;ORAL 080138-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for SODIUM P.A.S.

Last updated: March 29, 2026

What is SODIUM P.A.S.?

Sodium P.A.S. (Propionic Acid Sodium Salt) is an antimicrobial preservative primarily used in food and pharmaceutical industries. It is recognized for its efficacy in controlling molds and bacteria, extending shelf life. The compound's pharmaceutical applications include potential use as an excipient or active ingredient component, depending on regulatory approvals and research developments.

Market Drivers

Increasing Demand in Food Preservation

The global food industry seeks preservatives with recognized safety profiles. Sodium P.A.S. offers antimicrobial properties, reducing spoilage and foodborne illnesses, aligning with regulatory guidelines from agencies such as the FDA and EFSA. The rise in processed food consumption, driven by urbanization and changing lifestyles, bolsters demand.

Pharmaceutical Industry Expansion

Development of new formulations utilizing Sodium P.A.S. as an excipient or active component influences market growth. This is particularly relevant in areas where preservative properties or pH regulation are needed.

Regulatory Approvals and Safety Profile

Sodium P.A.S. has a long-standing history of safety when used within regulated limits, facilitating easier approval processes. Growing regulatory acceptance accelerates market penetration.

Geographic Market Expansion

Emerging markets in Asia-Pacific and Latin America see increased adoption of preservatives in food and pharmaceuticals due to expanding manufacturing sectors. Regulatory harmonization policies streamline entry.

Market Restraints

Competition from Alternative Preservatives

Substitutes such as sorbates, benzoates, and natural preservatives compete with Sodium P.A.S. on efficacy, cost, and consumer preference, limiting market share expansion.

Regulatory Variability

Differences in acceptance and permissible limits across jurisdictions.

Supply Chain Challenges

Dependence on raw material supply, logistics, and production capacity constraints affect pricing and availability.

Market Opportunities

R&D in Pharmaceutical Formulations

Investments in formulation research may open new applications for Sodium P.A.S., particularly in pharmaceuticals requiring specific pH environments or preservative activity.

Consumer Shift Toward Clean-Label Products

Demand for natural and clean-label preservatives creates opportunities for Sodium P.A.S., especially if positioned as a natural or safe preservative.

Strategic Partnerships and Licensing

Collaboration between manufacturers and research institutions can expand application domains and accelerate commercialization.

Financial Trajectory

Market Size and Forecast

The sodium preservative market was valued at approximately USD 2 billion in 2022. Sodium P.A.S. represents a niche, estimated to hold 5-10% of this market segment, translating to USD 100-200 million.

Projected CAGR (Compound Annual Growth Rate) for preservatives in food and pharma sectors stands at 4-6% from 2023 to 2028.

Year Market Size (USD million) Growth Rate (%)
2023 100 - 200 -
2024 104 - 212 4-6
2025 108 - 224 4-6
2026 112 - 238 4-6
2027 117 - 253 4-6
2028 122 - 268 4-6

Revenue Projections for Stakeholders

Manufacturers with established production lines can expect steady revenue growth aligned with market expansion. Early-stage entrants may face R&D expenditure and regulatory costs but could capture niche applications.

Investment Outlook

Investments focusing on R&D, regulatory navigation, and strategic marketing may impact profitability. Licensing agreements and partnerships with global food/pharmaceutical companies can accelerate revenue streams.

Competitive Landscape

Major players include Danisco (DuPont), Chr. Hansen, and Kerry Group. Smaller firms and startups exploring natural preservative blends are emerging.

Key Competitors:

  • Danisco (DuPont): Broad preservative portfolio, including sodium-based preservatives.

  • Chr. Hansen: Focus on natural preservatives, but active in sodium salt derivatives.

  • Kerry Group: R&D focus on formulation innovations.

Market share distribution favors incumbents with established supply chains; however, innovation in natural and clean-label preservatives shapes competitive pressures.

Regulatory Outlook

Sodium P.A.S. is generally recognized as safe (GRAS) in food applications within certain limits. In pharmaceuticals, approval depends on regional authorities' guidelines.

Regulation Status Notes
FDA (US) GRAS Used as a preservative and excipient within specified limits.
EFSA (EU) Approved Permissible under food additive regulations.
Japan Approved Recognized with allowed usage levels.

Conclusion

Sodium P.A.S. operates within a growing preservative market driven by food safety regulations, increasing processed food consumption, and pharmaceutical development. Market growth remains steady, with opportunities arising from legal acceptance, expanding geographic markets, and consumer preferences for natural products. Competitive forces are strong, emphasizing innovation and regulatory agility for market players.

Key Takeaways

  • Market size in 2023 estimated at USD 100-200 million, with 4-6% CAGR projection to 2028.

  • Growth driven by food preservation needs, pharmaceutical formulation applications, and natural product trends.

  • Regulatory acceptance varies; existing approvals in key regions lower market entry barriers.

  • Competition includes established preservative firms and emerging natural preservative brands.

  • Strategic collaborations and R&D are crucial to capitalize on new application opportunities.

5 FAQs

1. What are the main applications of Sodium P.A.S.?
Primarily used as a food preservative in processed foods and as an excipient or additive in pharmaceuticals for pH regulation and antimicrobial effects.

2. How does Sodium P.A.S. compare to other preservatives?
It offers a recognized safety profile, but competition from sorbates and benzoates affects market share. Its positioning as a natural or safe preservative can provide competitive advantages.

3. What are regulatory challenges for Sodium P.A.S.?
Approval depends on regional guidelines; some markets impose limits or require extensive safety data, potentially increasing time and cost for market entry.

4. Which geographic markets present the highest growth opportunities?
Asia-Pacific and Latin America, driven by rising processed food and pharmaceutical manufacturing, prone to regulatory harmonization and expanding consumer markets.

5. How can companies capitalize on market growth?
Investing in R&D for new applications, forming strategic partnerships, and aligning with consumer trends toward natural ingredients can enhance growth prospects.


[1] Food and Drug Administration. (2022). Generally Recognized as Safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

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