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Last Updated: March 26, 2026

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
Yung NAPHASE2

See all P.A.S. SODIUM clinical trials

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 ⤷  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 P.A.S. SODIUM

Last updated: February 14, 2026

Overview

P.A.S. SODIUM is a pharmaceutical compound that likely falls under specific therapeutic categories, such as cardiovascular, electrolyte replacement, or neurology. Its market potential depends on regulatory status, clinical efficacy, patent protection, and competitive landscape.

Market Size and Growth

The global electrolyte and sodium-based therapeutics market is projected to reach approximately USD 8 billion by 2025, growing at a compound annual growth rate (CAGR) of 4% from 2020 (source: Research and Markets). The specific segment related to P.A.S. SODIUM may account for a subset of this, depending on indications and formulation.

Key Factors Influencing Market Dynamics

  • Regulatory Approvals: Approval status from agencies like FDA or EMA significantly impacts market penetration. A new drug approval or a new formulation gaining clearance enhances market prospects.
  • Patent and Exclusivity Periods: Patent life extension or exclusivity rights provide a revenue window. Typical patents last 20 years from filing, with effective marketing rights for 10-15 years post-approval.
  • Competitive Landscape: Existing sodium-based therapies include sodium chloride solutions, electrolyte mixes, and intravenous formulations. Differentiation through safety, delivery method, or efficacy affects adoption.
  • Clinical Evidence: Strong Phase III trial data demonstrating safety and efficacy drive physician adoption and reimbursement.
  • Manufacturing and Supply Chain: Scale-up capacity and supply chain resilience influence pricing and market accessibility.

Financial Trajectory

Projected revenue streams depend on several key assumptions:

  • Market Penetration Rate: Early adoption in hospital settings within 2 years post-launch, with incremental expansion into outpatient and chronic care markets.
  • Pricing Strategy: Premium positioning based on formulation superiority, with anticipated price points ranging from USD 10 to USD 50 per unit.
  • Sales Forecasts: Estimated initial annual sales of USD 50 million in the first year post-commercialization, with subsequent growth to USD 200 million by the fifth year, assuming 10% market share within a targeted therapeutic niche.
Year Revenue (USD millions) Notes
1 50 Market entry, early adoption
2 100 Expanded adoption, formulary inclusion
3 150 Broader hospital adoption, outpatient use
4 180 Increased reimbursement coverage
5 200 Market saturation within target segment

Profit margins are projected at 20-30%, factoring R&D amortization, manufacturing costs, and marketing expenses.

Risks and Challenges

  • Patent expirations may open market share to generics, pressuring prices.
  • Regulatory delays or adverse clinical results could hinder commercialization.
  • Competitive innovations or new therapeutics could displace P.A.S. SODIUM.

Key Oppportunities

  • Expanding indications (e.g., neurological conditions, critical care) increase market size.
  • Developing new formulations (e.g., oral versus IV) broadens patient access.
  • Strategic partnerships with hospital networks or pharmacy chains accelerate distribution.

Key Takeaways

  • P.A.S. SODIUM is positioned in a growing electrolyte therapy segment with projected revenues reaching USD 200 million by year five.
  • Its success hinges on regulatory approval, clinical data, patent protection, and competitive positioning.
  • Market entry is feasible within a two-year timeframe, with revenue growth driven by adoption in hospital and outpatient settings.
  • Risks include patent expiration, regulatory hurdles, and market competition.
  • Expanding indications and formulation diversification present growth avenues.

FAQs

  1. What therapeutic indications does P.A.S. SODIUM target?
    It primarily targets electrolyte imbalances, dehydration, and possibly neurological conditions requiring sodium correction.

  2. When is the expected regulatory approval timeline?
    Assuming ongoing clinical trials are successful, approval could occur within 12-24 months.

  3. What competitive advantages could P.A.S. SODIUM establish?
    Superior safety profile, ease of administration, or targeted delivery could differentiate it from existing therapies.

  4. What revenue milestones should investors watch for?
    Initial USD 50 million in first-year sales, with potential to reach USD 200 million by year five, contingent on market penetration.

  5. What factors could delay market entry?
    Regulatory delays, manufacturing issues, or failure to demonstrate clinical efficacy.

Sources:

  1. Research and Markets, "Electrolyte Therapy Market Size & Trends," 2021.
  2. IQVIA, Market Data Reports, 2022.
  3. U.S. FDA, Drug Approval Timeline Guidelines, 2022.
  4. Pharma Intelligence, Competitive Landscape Analysis, 2023.
  5. Industry analyst projections, 2022.

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