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Last Updated: December 12, 2025

P.A.S. SODIUM Drug Patent Profile


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When do P.a.s. Sodium patents expire, and when can generic versions of P.a.s. Sodium launch?

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

The generic ingredient in P.A.S. SODIUM 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 P.A.S. SODIUM
Drug patent expirations by year for P.A.S. SODIUM
Recent Clinical Trials for P.A.S. SODIUM

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SponsorPhase
Nextrast, Inc.PHASE1
Eurofarma Laboratorios S.A.PHASE3
VA Office of Research and DevelopmentPHASE2

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Century Pharms P.A.S. SODIUM aminosalicylate sodium POWDER;ORAL 080947-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 P.A.S. Sodium

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by advancements in drug formulation, regulatory policies, and patient-centric therapies. P.A.S. Sodium (Potassium Aluminum Sulfate Sodium), a compound with diverse medical and industrial applications, is emerging within this complex environment. Understanding the market dynamics and financial trajectory for P.A.S. Sodium requires an analysis of its current usage, regulatory status, competitive landscape, and future growth drivers.


Overview of P.A.S. Sodium

P.A.S. Sodium, also known as aluminum potassium sulfate, is a chemical compound with established roles in pharmaceuticals, water purification, and cosmetics. Its medical applications include topical treatments for hemorrhoids and other dermatological uses, owing to its astringent and antiseptic properties. Industrially, it serves as a mordant in textile processing and in paper manufacturing, contributing to its stable demand base.

While not a novel molecule, P.A.S. Sodium's potential in emerging therapeutics and its recognition as a Generally Recognized as Safe (GRAS) substance in various contexts position it as a versatile compound with steady demand.


Market Dynamics

1. Global Medical Applications and Growth Drivers

The pharmaceutical sector remains the largest driver influencing P.A.S. Sodium's market dynamics. Its primary medical uses—particularly in topical formulations for skin conditions—are increasing due to rising global prevalence of dermatological diseases such as hemorrhoids, psoriasis, and skin infections. Moreover, P.A.S. Sodium's minimal toxicity profile supports its ongoing use in over-the-counter (OTC) products.

The aging population in developed regions, notably North America and Europe, contributes to increased demand for such dermatological treatments. Simultaneously, emerging markets in Asia-Pacific exhibit expanding healthcare infrastructure, creating new opportunities for P.A.S. Sodium-based formulations.

2. Regulatory and Safety Landscape

Regulatory frameworks significantly influence market access and expansion. P.A.S. Sodium benefits from decades of regulatory acceptance in topical and medicinal applications, with approvals from entities such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Nonetheless, future authorization hinges on rigorous safety evaluations, especially if new therapeutics involving P.A.S. Sodium are developed.

The compound’s recognized safety profile supports its continued use; however, any regulatory restrictions or safety concerns introduced—such as potential aluminum accumulation—could impact demand[1].

3. Industrial and Non-Medical Applications

Beyond medical uses, P.A.S. Sodium maintains potency in industrial sectors. The textile industry's reliance on mordants and the paper industry's demand for fillers contribute to consistent demand. The sustainability trends and environmental regulations, emphasizing less toxic and eco-friendly chemicals, influence the broader industrial application market.

4. Competitive Dynamics

The market faces competition from alternative compounds with similar properties, such as other astringents or mordants. Innovation in drug delivery systems and formulation technology may alter the competitive landscape, favoring compounds with enhanced efficacy or reduced side effects.

Emerging bio-based or biodegradable substitutes could challenge P.A.S. Sodium in specific applications, especially if environmental regulations tighten.

5. Supply Chain and Raw Material Factors

Supply stability of raw materials—primarily aluminum, potassium, and sulfur—is crucial. Global supply chain disruptions could influence pricing and availability. The increasing focus on sustainable mining and sourcing practices may impact costs but also present opportunities for brands emphasizing ethically sourced materials.


Financial Trajectory

1. Historical Performance and Market Size

While exact revenues for P.A.S. Sodium are not publicly available due to its prevalence as a component rather than a standalone drug, the larger market for topical astringents and industrial chemicals provides proxy insights.

The global pharmaceutical excipients market alone was valued at approximately $11 billion in 2021, with growth driven by formulation innovations[2]. P.A.S. Sodium’s role as a specialty excipient and active component predicates a steady, if niche, share of this market.

2. Forecasted Growth

The compound's growth is projected to mirror that of the dermatology market, which is anticipated to grow at a compound annual growth rate (CAGR) of around 5-7% through 2030. Specialty pharmaceutical formulations using P.A.S. Sodium are expected to capitalize on the increasing demand for safe, effective OTC treatments.

Industrial applications are projected to grow at a moderate CAGR of 3-4%, influenced by global infrastructure projects and the push towards sustainable materials. Combined, these sectors could push P.A.S. Sodium’s market value toward a compounded growth trajectory reaching several hundred million dollars globally within the next decade[3].

3. Investment and R&D Opportunities

Investments in formulation innovations could unlock new therapeutic indications, increasing the compound’s value. R&D in nano-formulations or controlled-release systems involving P.A.S. Sodium may enhance efficacy, safety, and delivery—further bolstering its financial prospects.

Moreover, strategic collaborations with biotech and pharmaceutical companies can accelerate product development, expand indications, and improve market penetration.

4. Challenges and Risks

Key risks include regulatory hurdles, potential toxicity concerns, and the advent of substitutes. Market volatility due to raw material price fluctuations or geopolitical factors may affect profitability. The compound’s niche status may limit significant revenue streams without product differentiation or expanded indications.


Conclusion

The market for P.A.S. Sodium is characterized by steady demand driven by medical and industrial applications. Its favorable safety profile and established regulatory acceptance support its current trajectory, with growth bolstered by aging populations and expanding healthcare infrastructure in emerging markets.

Financial growth will depend on innovation, regulatory navigation, and supply chain stability. While the compound's global market size remains relatively niche, strategic focus on pharmaceutical formulation advancements and industrial sustainability trends can unlock substantial value over the next decade.


Key Takeaways

  • Growing Medical Demand: Increasing prevalence of dermatological conditions and a preference for OTC treatments promote steady demand for P.A.S. Sodium-based products.
  • Regulatory Favorability: Long-standing safety approvals facilitate market access, though future regulatory changes could pose challenges.
  • Industrial Stability: Consistent demand from textile and paper industries offers diversification but remains sensitive to environmental policies.
  • Innovation as a Driver: R&D in optimized formulations and new indications can significantly influence financial outcomes.
  • Supply Chain & Raw Material Risks: Ensuring sustainable sourcing and mitigating raw material cost volatility are critical for profit stability.

FAQs

1. What are the primary medicinal applications of P.A.S. Sodium?
P.A.S. Sodium is mainly used in topical formulations for hemorrhoids, skin infections, and as an astringent in dermatological treatments, owing to its antiseptic and vasoconstrictive properties.

2. How does regulatory status impact P.A.S. Sodium's market growth?
Regulatory approval and safety assessments underpin market confidence. Positive regulatory environments facilitate commercialization, while new restrictions could hamper growth or necessitate reformulation.

3. Are there any environmental concerns associated with P.A.S. Sodium?
As an industrial chemical, it is generally considered stable, but environmental regulations aiming to reduce ecological impact may influence its industrial uses and sourcing practices.

4. What competitive factors influence P.A.S. Sodium's market share?
Competition arises from alternative astringent compounds, innovative drug delivery systems, and eco-friendly substitutes. Market leadership depends on safety profile, formulation efficacy, and regulatory compliance.

5. What is the outlook for investment in P.A.S. Sodium-related industries?
Steady growth in pharmaceutical formulations and industrial applications presents investment opportunities, particularly where innovation and sustainable sourcing strategies align with market trends.


Sources:

[1] U.S. FDA. "Guidance for Industry: Toxicological Principles for the Safety Assessment of Food Ingredients." 2012.

[2] MarketsandMarkets. "Pharmaceutical Excipients Market." 2022.

[3] Grand View Research. "Dermatology Drugs Market Size, Share & Trends." 2022.

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