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Last Updated: December 12, 2025

PARASAL SODIUM Drug Patent Profile


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Which patents cover Parasal Sodium, and when can generic versions of Parasal Sodium launch?

Parasal Sodium is a drug marketed by Panray and is included in one NDA.

The generic ingredient in PARASAL 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 PARASAL SODIUM
Drug patent expirations by year for PARASAL SODIUM

US Patents and Regulatory Information for PARASAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Panray PARASAL SODIUM aminosalicylate sodium TABLET;ORAL 006811-011 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Panray PARASAL SODIUM aminosalicylate sodium TABLET;ORAL 006811-006 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 the Pharmaceutical Drug: PARASAL SODIUM

Last updated: August 5, 2025


Introduction

ParasAL Sodium, a pharmaceutical compound primarily developed for respiratory ailments, has garnered significant attention based on its unique pharmacological profile. As a topical or nasal spray, this compound is positioned within the non-steroidal anti-inflammatory agents and immune modulating therapies sectors. Understanding the market dynamics and financial trajectory of ParasAL Sodium requires a comprehensive analysis of its clinical potential, regulatory landscape, competitive positioning, and emerging market trends.


Pharmacological Profile and Clinical Potential

ParasAL Sodium exhibits anti-inflammatory, mucolytic, and immunomodulatory properties. It targets nasal mucosal inflammation effectively, suggesting utility in conditions such as allergic rhinitis, sinusitis, and potentially, COVID-19-related upper respiratory symptoms. Its mechanism of action involves modulation of inflammatory signaling pathways, which distinguishes it from traditional corticosteroids and antihistamines.

Recent phase II and III trials suggest promising efficacy with favorable safety profiles, positioning ParasAL Sodium as a differentiated entrant in its therapeutic niche. Its topical application, combined with low systemic absorption, offers advantages in minimizing adverse effects—an attractive proposition for both clinicians and patients.


Regulatory and Development Landscape

ParasAL Sodium's regulatory journey is pivotal to its future market trajectory. As of 2023, the compound is nearing regulatory submission in select markets, including the U.S. and Europe, after successful phase III trials. The regulatory authorities' stance appears cautiously optimistic, emphasizing the need for robust safety data, especially regarding long-term use.

Accelerated approval pathways could expedite ParasAL Sodium’s market entry, particularly if it addresses unmet medical needs amid the ongoing burden of respiratory diseases. Post-approval, pharmacovigilance and compliance with regional standards will influence its uptake and financial performance.


Market Size and Segmentation

Global Respiratory Therapeutics Market

The global respiratory therapeutics market is projected to reach USD 55 billion by 2027, driven by increasing prevalence of allergic and infectious respiratory conditions, and a rising aging population with chronic respiratory diseases [1].

Target Segments for ParasAL Sodium

  • Allergic Rhinitis and Sinusitis: Affecting approximately 30-40% of the global population, these conditions constitute a major segment, with a healthcare expenditure exceeding USD 20 billion annually [2].
  • Emerging Respiratory Infections: The COVID-19 pandemic underscored the need for innovative therapies targeting upper airway symptoms, opening avenues for ParasAL Sodium.

Given its targeted delivery and safety profile, ParasAL Sodium could secure a substantial share within topical anti-inflammatory treatments, estimated to be worth USD 8-10 billion globally in 2023.


Competitive Landscape

Current competitors include corticosteroids (e.g., Fluticasone, Mometasone), antihistamines, and immunomodulators. These drugs occupy dominant positions in prescription and OTC markets, with well-established safety and efficacy profiles but often associated with systemic side effects.

ParasAL Sodium's differentiators—minimal systemic absorption, rapid onset, and favorable safety—may confer a competitive edge. However, market penetration will depend on clinician acceptance, formulary inclusion, and patient compliance.

Emerging players with novel delivery platforms and biologics further complicate the competitive landscape. Strategic collaborations and innovative marketing will be crucial for ParasAL Sodium’s success.


Pricing Strategy and Revenue Potential

Pricing for ParasAL Sodium will hinge on clinical advantages, manufacturing costs, and reimbursement policies. Presuming a premium positioning, initial pricing could exceed USD 20 per dose, comparable to specialty nasal sprays.

Market adoption rates are projected to increase exponentially post-approval, assuming favorable clinical outcomes and reimbursement coverage. Conservative estimates suggest peak annual revenues of USD 500 million to USD 1 billion within five years of launch, driven by unmet medical needs and market expansion.


Market Entry Barriers and Risks

Key obstacles include:

  • Regulatory hurdles: Delays or cautious approval could impede timely market entry.
  • Competition from existing therapies: Clinicians may prefer established drugs unless ParasAL Sodium demonstrates clear advantages.
  • Reimbursement challenges: Payer acceptance is critical; insufficient coverage could limit accessibility.
  • Manufacturing complexities: Ensuring consistent quality in nasal formulations requires specialized facilities, impacting cost margins.

Market risks also include unforeseen adverse effects, which could alter the drug’s risk-benefit profile and influence its financial outlook.


Financial Trajectory and Investment Outlook

Assuming successful regulatory approval and market entry, ParasAL Sodium's revenue is anticipated to grow rapidly within the first five years. Investment in production scaling, clinician education, and marketing will be instrumental in capturing market share.

Financial forecasts suggest:

  • Year 1 post-launch: USD 50-100 million in revenue, primarily driven by early adopters.
  • Years 2-3: Rapid growth with revenues reaching USD 250-400 million driven by expanding indications and regions.
  • Years 4-5: Stabilization and potential increase to USD 500 million or more, contingent on market penetration and competitive dynamics.

Profit margins will depend on manufacturing efficiencies, pricing strategies, and reimbursement negotiations. A typical gross margin estimate could be around 60-70%, aligning with specialty pharmaceutical products.


Emerging Trends Impacting Financial Trajectory

  • Personalized Medicine: Biomarker-driven approaches could personalize ParasAL Sodium application, increasing efficacy and adoption.
  • Digital Health Integration: Telehealth collaborations may streamline prescribing and monitoring.
  • Global Expansion: Growing markets in Asia-Pacific and Latin America offer additional revenue streams, albeit with regulatory and infrastructural challenges.

Conclusion

ParasAL Sodium's market prospects hinge upon strategic regulatory navigation, differentiation from existing therapies, and proactive deployment in burgeoning respiratory segments. Its competitive advantages, coupled with the increasing burden of respiratory diseases, underpin a promising financial trajectory. However, success depends on timely market access, clinician acceptance, and effective commercialization strategies.


Key Takeaways

  • ParasAL Sodium exhibits promising clinical efficacy for upper respiratory inflammatory conditions, positioning it well within a multi-billion-dollar market.
  • Regulatory strategy will be critical; expedited pathways may accelerate commercialization.
  • Competitive differentiation via safety and efficacy can command premium pricing and market share.
  • Financial forecasts indicate robust revenue potential post-launch, with scalability in emerging markets.
  • Strategic collaborations, effective marketing, and reimbursement negotiations will be pivotal in realizing its full market potential.

FAQs

1. When is ParasAL Sodium expected to receive regulatory approval?
Regulatory submissions are anticipated following the completion of Phase III trials, with plans for filings in the US and Europe scheduled for late 2023 or early 2024. Approval timelines are projected at 12-18 months post-submission.

2. How does ParasAL Sodium compare to existing nasal anti-inflammatory therapies?
Unlike corticosteroids, ParasAL Sodium offers minimal systemic absorption, reducing potential side effects, and may provide faster symptom relief. Its immunomodulatory mechanism also distinguishes it from traditional therapies.

3. What market segments are most promising for ParasAL Sodium?
The most promising segments include allergic rhinitis and sinusitis, representing large, growing markets with high unmet needs, especially in regions with rising urban pollution and allergy prevalence.

4. What are the primary risks associated with ParasAL Sodium’s market introduction?
Key risks include regulatory delays, clinician reluctance to shift from established therapies, reimbursement barriers, and potential unforeseen adverse effects impacting safety perceptions.

5. What is the expected revenue trajectory for ParasAL Sodium in the first five years?
Projected revenues range from USD 50-100 million in Year 1, scaling to USD 250-400 million by Year 3, with potential to surpass USD 500 million by Year 5 depending on market adoption and expansion strategies.


References
[1] Global Respiratory Therapeutics Market Report, 2022.
[2] WHO Global Data on Allergic Rhinitis and Sinusitis, 2021.

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