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Last Updated: December 12, 2025

PANIXINE DISPERDOSE Drug Patent Profile


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Which patents cover Panixine Disperdose, and when can generic versions of Panixine Disperdose launch?

Panixine Disperdose is a drug marketed by Ranbaxy Labs Ltd and is included in one NDA.

The generic ingredient in PANIXINE DISPERDOSE is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the cephalexin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Panixine Disperdose

A generic version of PANIXINE DISPERDOSE was approved as cephalexin by TEVA on February 13th, 1987.

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Summary for PANIXINE DISPERDOSE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 1
DailyMed Link:PANIXINE DISPERDOSE at DailyMed
Drug patent expirations by year for PANIXINE DISPERDOSE
Recent Clinical Trials for PANIXINE DISPERDOSE

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SponsorPhase
Merck Sharp & Dohme Corp.Phase 1

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US Patents and Regulatory Information for PANIXINE DISPERDOSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy Labs Ltd PANIXINE DISPERDOSE cephalexin TABLET, FOR SUSPENSION;ORAL 065100-002 Sep 11, 2003 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ranbaxy Labs Ltd PANIXINE DISPERDOSE cephalexin TABLET, FOR SUSPENSION;ORAL 065100-001 Sep 11, 2003 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 of PANIXINE DISPERDOSE

Last updated: August 6, 2025

Introduction
Panixine Disperdose, a proprietary formulation of Sulfisoxazole, is an antibacterial agent historically utilized in the treatment of urinary tract infections (UTIs) and other bacterial diseases. Its unique dispersible formulation enhances patient compliance, particularly in pediatric populations. Despite being established for decades, evolving market dynamics, regulatory shifts, and emerging antimicrobial resistance influence its current and future financial trajectory. This report delineates the market environment, competitive landscape, regulatory factors, and financial outlook for Panixine Disperdose.

Market Overview and Segmentation
The global antibacterial market, valued at approximately USD 45 billion in 2022, continues to grow at a compounded annual growth rate (CAGR) of around 3.5%. Within this landscape, sulfonamides, including Sulfisoxazole, represent a diminishing segment driven by decreasing antibiotic pipelines, antimicrobial resistance, and regulatory constraints. Nonetheless, irregular preferences persist in specific geographies and niche indications.

Panixine Disperdose primarily targets pediatric and outpatient markets, where dispersible formulations improve ease of administration. The segment is further subdivided into regions with high antibiotic consumption, notably Asia-Pacific, Latin America, and parts of Africa, driven by infectious disease burdens and limited healthcare infrastructure.

Market Drivers

  • Demographic Factors: Rising pediatric populations in emerging markets amplify demand for dispersible antibiotics, including Panixine Disperdose. In countries like India and Nigeria, childhood UTIs constitute a significant disease burden.
  • Compliance and Convenience: Patient-friendly formulations boost adherence, vital in pediatric therapy. Dispersible tablets offer a logistical advantage, especially in rural or resource-limited settings.
  • Limited Competition: Due to regulatory complexities and antimicrobial stewardship initiatives, the pipeline for new sulfonamide antibiotics remains sparse, bolstering the relevance of existing agents like Panixine Disperdose.
  • Growing Awareness: Increased healthcare awareness campaigns about bacterial infections foster demand for effective antibiotic regimens, indirectly benefiting existing formulations.

Market Challenges and Risks

  • Antimicrobial Resistance (AMR): A significant threat to the sulfonamide class, with resistance rates escalating worldwide. The efficacy of Sulfisoxazole is compromised in resistant strains, leading to diminished clinical use.
  • Regulatory Scrutiny: Stringent antimicrobial stewardship policies across developed markets have curtailed antibiotic prescriptions, reducing market size.
  • Generic Competition: Multiple generics of Sulfisoxazole exist, exerting price pressures. Patents for Panixine Disperdose have largely expired, intensifying price erosion.
  • Evolving Guidelines: Medical entities increasingly favor newer, broad-spectrum antibiotics over traditional agents, impacting demand.

Regulatory Landscape
Globally, agencies emphasize responsible antibiotic usage, with many jurisdictions implementing restrictions on prescribing older antibiotics like Sulfisoxazole. In the US, the FDA has not recently approved new formulations or indications for Panixine Disperdose, and existing approvals are primarily for off-patent, generic formulations. Internationally, regulatory environments vary, with some countries restricting or discouraging the use of older sulfonamides due to resistance issues.

Financial Trajectory and Market Potential
The revenue prospects of Panixine Disperdose are constrained by declining clinical relevance and the rise of resistance. Nonetheless, niche applications in pediatric antibiotics, compounded formulations, and specific regional markets may sustain moderate sales. The following factors influence its financial trajectory:

  • Current Sales: Global sales likely peaked during the 2000s. Presently, revenues are declining due to reduced prescriptions and intense price competition.
  • Pricing Dynamics: As patents have expired, generic manufacturers dominate, leading to significant price erosion. The dispersible formulation commands a small premium but is challenged by commoditization.
  • Market Expansion Opportunities: Limited opportunities exist for growth in developed markets absent new indications or formulations. However, emerging markets and orphan indications could provide incremental revenues.
  • Pipeline and Reformulation Strategies: There is minimal evidence of ongoing development or reformulation efforts for Panixine Disperdose. Market revivals would necessitate strategic innovation or new clinical evidence demonstrating efficacy amid resistance concerns.

Competitive Landscape
The sulfonamide class faces diminished interest from major pharmaceutical firms, with most market activity concentrated among generic players. Alternative antibiotics—fluoroquinolones, cephalosporins, and aminoglycosides—offer broader spectrum and are increasingly favored. This landscape renders Panixine Disperdose a niche product, susceptible to commoditization but potentially valuable for specific regional or pediatric use.

Future Outlook and Recommendations
Given the confluence of resistance, regulatory policies, and market saturation, the financial outlook for Panixine Disperdose remains subdued. Strategic focus areas include:

  • Targeted Niche Markets: Focus on pediatric populations in regions with high UTIs and limited access to newer antibiotics.
  • Formulation Innovation: Development of fixed-dose combinations or novel dispersible formulations to extend product relevance.
  • Regulatory Engagement: Seek approvals for new indications or pediatric uses in jurisdictions with less restrictive policies.
  • Market Diversification: Explore supply agreements with government health programs, NGOs, and humanitarian initiatives where older antibiotics remain essential.

Key Takeaways

  • The global antibiotic market is shifting toward newer agents, adversely affecting the financial viability of traditional agents like Panixine Disperdose.
  • Resistance and regulatory hurdles have curtailed sales, positioning Panixine Disperdose as a niche, primarily regional product.
  • Opportunities exist in targeted pediatric markets and orphan indications but require strategic innovation and regulatory navigation.
  • Price erosion due to generic competition underscores the importance of formulation differentiation and regional market focus.
  • Maintaining relevance demands a strategic combination of market insights, formulation advancements, and targeted regulatory engagement.

FAQs

1. What factors most significantly impact Panixine Disperdose’s market viability?
Antimicrobial resistance, regulatory restrictions, generic competition, and shifts in clinical prescribing practices are primary determinants of its market viability.

2. Are there any recent developments or innovations for Panixine Disperdose?
Currently, there are limited new developments. Most activity revolves around generic manufacturing, with minimal reformulation or indication expansion.

3. How does antimicrobial resistance influence Panixine Disperdose sales?
Rising resistance reduces the clinical efficacy of Sulfisoxazole, leading healthcare providers to favor alternative antibiotics, thereby diminishing demand.

4. What regions offer the most growth potential for Panixine Disperdose?
Emerging markets like India, Nigeria, and other parts of Africa, where older antibiotics remain relevant due to limited access to newer agents, present growth opportunities.

5. What strategic actions can manufacturer stakeholders pursue?
Innovating formulations, target niche pediatric markets, engage with regulatory authorities for expanded indications, and establish supply agreements in underserved regions.

References
[1] Global Antibacterial Market Report 2022. MarketsandMarkets.
[2] World Health Organization. Antimicrobial Resistance Global Report 2022.
[3] U.S. Food and Drug Administration. Drug Approvals and Safety Alerts.
[4] Market Dynamics and Competitive Landscape, Pharma Intelligence.
[5] Recent Patent and Formulation Trends in Antibiotics, Scientific Journals.

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