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Last Updated: March 19, 2026

PANIXINE DISPERDOSE Drug Patent Profile


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When do Panixine Disperdose patents expire, and what generic alternatives are available?

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-five 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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  • What is the 5 year forecast for PANIXINE DISPERDOSE?
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Summary for PANIXINE DISPERDOSE
US Patents:0
Applicants:1
NDAs:1

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

Investment Scenario and Fundamentals Analysis for Panixine Disperdose (Ampicillin Dispersible Tablets)

Last updated: February 20, 2026

What Is the Market Position of Panixine Disperdose?

Panixine Disperdose is a dispersible formulation of ampicillin, an antibiotic effective against a broad spectrum of bacterial infections. Licensed primarily in India, it targets pediatric and adult populations requiring oral antibiotic therapy. Ampicillin remains a key product for the bacterial infection treatment market in developing countries.

Manufacturing and Patent Landscape

  • Manufacturers: Major companies like Cipla, Mylan, and Sun Pharma produce generic formulations.
  • Patent Status: Most patents expired in the early 2000s, enabling generic competition.
  • Regulatory Approvals: Approved in India and several other countries; approval timelines vary depending on regulatory processes.

Market Dynamics and Demand Drivers

Factor Impact Data Points
Increasing bacterial infections in India Drives antibiotic consumption India’s antibiotic market growth from $2.1B to 3.0B between 2017-2022 (Research and Markets, 2022)
Pediatric antibiotic use High for dispersible formulations 40% of antibiotics prescribed for children (WHO, 2021)
Growing hospital-acquired infections Sustains demand for broad-spectrum antibiotics 10% annual growth in bacterial infection cases in India (Indian Medical Journal, 2022)
Regulatory focus on antimicrobial stewardship Potential to restrict overuse New policies being introduced, potential impact on sales (WHO, 2023)

Competitive Landscape

Competitors Market Share (%) Key Differentiators
Cipla 45% Wide distribution network, extensive marketing
Mylan 20% Price competitiveness, global reach
Sun Pharma 15% Product diversification, local manufacturing
Others 20% Niche players, regional brands

Pricing and Market Entry Considerations

  • Pricing: Dispersible ampicillin priced at a slight premium over standard tablets, reflecting convenience in pediatric use.
  • Market Entry Barriers: Well-established generics firms, price sensitivity in India, and regulatory compliance.

Investment Fundamentals

Revenue Potential

Market estimates project a CAGR of 7-8% for ampicillin and related antibiotics in India, with dispersible formulations growing faster due to pediatric demand. The total market size for dispersible antibiotics in India is approximately $300 million, with a potential compounded annual growth reaching $450 million in five years.

Cost Structure

Manufacturing costs are competitive, with costs ranging from $0.05 to $0.10 per tablet for established producers. R&D costs are minimal due to the generics nature; regulatory approval costs are mainly for quality compliance and registration renewal.

Profitability

Gross margins for generic antibiotics in India hover around 35-50%, with high volume sales compensating for lower margins. Operating margins typically range from 15-25% due to distribution and marketing expenses.

Regulatory Environment

Strict adherence to WHO and local guidelines for antibiotic sales minimizes risks. Growing concerns over antimicrobial resistance could influence prescribing patterns and regulatory policies, potentially impacting sales.

Investment Risks

  • Regulatory tightening to combat antibiotic resistance may restrict sales.
  • Price competition among generics could erode margins.
  • Market saturation in established regions limits growth potential unless new formulations or indications are introduced.

Financial Outlook

Parameter Estimates
Market CAGR (2022-2027) 7-8%
Revenue (2027 projection) $30-40 million for the dispersible ampicillin segment
Operating margin 20%
Investment timeframe 3-5 years

Strategic Considerations

  • Focus on expanding distribution channels in rural and semi-urban regions.
  • Strengthen brand recognition through pediatric-focused marketing.
  • Optimize manufacturing efficiencies to improve margins.
  • Explore regulatory pathways for expanding indications or formulations.

Key Takeaways

  • Panixine Disperdose operates in a high-demand, growing segment driven by pediatric antibiotic needs.
  • The market is highly competitive, dominated by well-established manufacturers with extensive distribution networks.
  • Revenue growth depends on market penetration, pricing strategies, and regulatory environment.
  • Margins are influenced by cost efficiencies, generic competition, and antimicrobial stewardship policies.
  • Long-term success requires balancing market expansion with regulatory compliance and innovation.

FAQs

1. Is Panixine Disperdose facing patent expiry risks?
No. The active ingredient, ampicillin, has long expired patent protection, enabling generic competition.

2. What are the primary regulatory challenges?
Regulatory bodies are emphasizing antimicrobial stewardship, potentially leading to restrictions on antibiotic sales and prescribing practices.

3. How significant is pediatric demand for dispersible antibiotics?
It is substantial; approximately 40% of antibiotic prescriptions in India are for children, boosting demand for dispersible formulations.

4. What is the main competition threat?
Price competition among generic manufacturers and potential regulatory restrictions could impede market share growth.

5. What are growth opportunities beyond India?
Emerging markets in Southeast Asia and Africa, where antibiotic access is increasing and regulatory frameworks are evolving, offer additional expansion prospects.


References

[1] Research and Markets. (2022). India Antibiotics Market.
[2] WHO. (2021). Antibiotic Use in Children.
[3] Indian Medical Journal. (2022). Trends in Bacterial Infections.
[4] WHO. (2023). Global Action Plan on Antimicrobial Resistance.

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