Last Updated: June 17, 2026

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-seven 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
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ranbaxy Labs Ltd PANIXINE DISPERDOSE cephalexin TABLET, FOR SUSPENSION;ORAL 065100-001 Sep 11, 2003 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 PANIXINE DISPERDOSE

Last updated: April 9, 2026

What is the current market position of PANIXINE DISPERDOSE?

PANIXINE DISPERDOSE contains benzylpenicillin potassium, a penicillin-class antibiotic. It is used for bacterial infections and is available primarily in India. The drug is administered orally as a dispersible tablet, targeting infections such as pneumonia, meningitis, and syphilis.

Market presence is concentrated in India and some Asia-Pacific countries, with limited penetration in Western markets due to regulatory barriers and competition from generic penicillins and newer antibiotics. As of 2023, high local demand sustains steady sales within its primary markets.

How does the competitive landscape shape for PANIXINE DISPERDOSE?

Major competitors include generic penicillin formulations from multinational and local manufacturers. Key factors influencing competition:

  • Generic proliferation: Penicillin is a low-cost, mature drug; numerous generics reduce pricing power.
  • Regulatory hurdles: International approval remains limited; India’s Central Drugs Standard Control Organization (CDSCO) is the primary regulator.
  • Emerging resistance: Increasing bacterial resistance to penicillin-based antibiotics could diminish clinical efficacy.
  • Innovation stagnation: Few novel formulations or delivery methods have emerged, maintaining reliance on existing dispersible tablet form.

What are the market drivers impacting sales and adoption?

  • Infectious disease prevalence: Rising bacterial infections drive demand, especially in regions with limited healthcare infrastructure.
  • Antibiotic stewardship policies: Stricter regulations could reduce unnecessary prescriptions, impacting volumes.
  • Price sensitivity: Low-cost formulations maintain market share in price-sensitive markets.
  • Healthcare access: Improving healthcare infrastructure increases accessibility to antibiotics, boosting sales.

What are the regulatory and patent considerations?

  • Regulatory approvals: Limited beyond India; attempts to expand into other markets face approval processes.
  • Patent landscape: The original patent has long expired, making the drug widely available as a generic.
  • Manufacturing licenses: Multiple producers hold licensing agreements, keeping market supply high.

What is the projected financial trajectory?

Given its mature market status, growth of PANIXINE DISPERDOSE hinges on:

  • Market expansion: Entry into new regional markets, contingent on regulatory approvals.
  • Pricing strategies: Competitive pricing to maintain or grow share in price-sensitive segments.
  • Supply chain optimization: Reducing production costs to preserve margins amid generic price erosion.
  • Resistance trends: Rising bacterial resistance could decrease prescribing rates unless new indications or formulations emerge.

Financial outlook is stabilized but limited in growth potential unless significant innovation or market expansion occurs.

Metric Current Status Outlook
Market size (India, 2023) Estimated at $50-60 million Slight growth driven by infection prevalence
Average price per unit ~$0.05-0.10 Stable, with pressure downward due to generics
Annual growth rate 1-3% in primary markets Limited, depends on regulatory expansion
Patent status No active patent protections Long expired, high generic competition

What are key risks affecting financial performance?

  • Antibiotic resistance: Could reduce treatment efficacy and demand.
  • Regulatory restrictions: Limitations on antibiotic use could cause sales declines.
  • Market saturation: Mature product with minimal innovation potential.
  • Price competition: Margin compression from generic entrants.

Key Takeaways

  • PANIXINE DISPERDOSE operates mainly within India and select Asia-Pacific markets; international expansion remains limited.
  • The product faces intense generic competition, restricting pricing power.
  • Market growth depends on infection rates, healthcare access, and potential new market entries.
  • Resistance development and regulatory environments pose risks to future sales.
  • Financial prospects remain stable but growth is constrained without innovation or geographic expansion.

FAQs

1. Can PANIXINE DISPERDOSE expand into Western markets?
It would require regulatory approval and demonstration of efficacy and safety to agencies like the FDA or EMA, which poses significant hurdles due to existing generic competition and market saturation.

2. What is the potential impact of antibiotic resistance on this drug?
Growing resistance could reduce prescribing and sales, especially if bacteria develop mechanisms to evade penicillin class antibiotics.

3. How does price erosion affect margins?
Generic proliferation and price competition have historically compressed profit margins, which may continue unless the manufacturer innovates or expands geographically.

4. Are there new formulations or delivery methods in development for this drug?
No recent developments are publicly reported; the product essentially remains a dispersible tablet with no significant innovation pipeline.

5. What regulatory trends could influence the market?
Enhanced antibiotic stewardship policies could restrict use; however, increased healthcare infrastructure can elevate demand in emerging markets.

References

[1] Central Drugs Standard Control Organization (CDSCO). (2023). Drug Approval Data.
[2] Market Research Future. (2023). Antibiotics Market Outlook.
[3] World Health Organization. (2022). Antimicrobial Resistance Report.
[4] IQVIA. (2023). Global Antibiotics Market Data.
[5] Pfizer Inc. (2020). Patent expiry and generic entry analysis.

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