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Last Updated: December 11, 2025

POLYTRIM Drug Patent Profile


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

Polytrim is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in POLYTRIM is polymyxin b sulfate; trimethoprim sulfate. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate; trimethoprim sulfate profile page.

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Summary for POLYTRIM
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 173
Clinical Trials: 1
Drug Prices: Drug price information for POLYTRIM
What excipients (inactive ingredients) are in POLYTRIM?POLYTRIM excipients list
DailyMed Link:POLYTRIM at DailyMed
Drug patent expirations by year for POLYTRIM
Drug Prices for POLYTRIM

See drug prices for POLYTRIM

Recent Clinical Trials for POLYTRIM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of RochesterPhase 4

See all POLYTRIM clinical trials

US Patents and Regulatory Information for POLYTRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan POLYTRIM polymyxin b sulfate; trimethoprim sulfate SOLUTION/DROPS;OPHTHALMIC 050567-001 Oct 20, 1988 DISCN Yes 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: POLYTRIM

Last updated: July 29, 2025


Introduction

POLYTRIM, a broad-spectrum antimicrobial agent, has established its presence within the pharmaceutical landscape primarily for topical applications. Its active ingredients, typically comprising polymyxin B and trimethoprim, target bacterial infections, notably in skin and eye formulations. As antimicrobial resistance (AMR) escalates globally, drugs like POLYTRIM are experiencing evolving market dynamics influenced by regulatory, clinical, and competitive factors. This analysis explores the current and future market trajectory of POLYTRIM, emphasizing key drivers, barriers, and financial forecasts.


Market Overview

The antimicrobial topical agent segment, encompassing antibiotics like POLYTRIM, caters significantly to outpatient and hospital settings. The global demand stems from rising bacterial infections, increased surgical procedures, and the necessity for effective wound care. The market's value is projected to witness robust growth driven by expanding healthcare infrastructure in emerging economies, aging populations, and rising prevalence of dermatological conditions requiring antimicrobial treatment.

Key Players and Market Share: Predominant manufacturers include local and multinational pharmaceutical firms, with established brands like POLYTRIM maintaining their positions via formulation patent protections and distribution networks. Although generic versions exist, patent versatility and clinical preference sustain POLYTRIM’s market share.


Market Drivers

1. Rising Incidence of Bacterial Infections

The uptick in bacterial skin and eye infections, exacerbated by increased urbanization and environmental pollutants, propels demand for efficacious topical antibiotics. For instance, conjunctivitis and wound infections remain prevalent in both developed and developing nations, necessitating effective therapeutics like POLYTRIM.

2. Growing Surgical and Wound Care Procedures

A surge in elective surgeries, coupled with the global emphasis on wound management, boosts the required topical antimicrobials to prevent postoperative infections. POLYTRIM’s spectrum of activity aligns well with these clinical needs.

3. Antimicrobial Resistance (AMR) Management Strategies

While AMR poses a threat to traditional antibiotics, formulations with proven efficacy and minimal resistance development, like POLYTRIM, are increasingly favored. Regulatory agencies emphasize stewardship, favoring drugs with validated safety and resistance profiles, bolstering demand.

4. Regulatory Environment and Approvals

Stringent approval pathways necessitate rigorous clinical data; however, once approved, regulatory stability ensures sustained market presence. POLYTRIM's existing approvals in key markets (e.g., FDA in the U.S., EMA in Europe) support ongoing sales.


Market Barriers

1. Rising Antibiotic Resistance

Emerging resistance to polymyxins and trimethoprim could compromise therapeutic effectiveness, potentially leading to reduced usage. This necessitates continuous surveillance and formulation adjustments.

2. Generic Competition

The expiration of patent protections and the proliferation of generic alternatives pose significant pricing pressures. Price erosion can impact profitability for original formulations like POLYTRIM.

3. Regulatory and Safety Concerns

Potential adverse effects, contraindications, or stricter regulations, especially concerning systemic absorption and toxicity, may restrict broader application and dent market growth.

4. Limited Indication Expansion

Currently, POLYTRIM's indications are confined mostly to topical bacterial infections. Lack of broader systemic or novel therapeutic claims may restrict growth, especially with competitors developing advanced formulations.


Financial Trajectory and Forecasts

Historical Performance

While precise sales figures are proprietary, POLYTRIM's sales have historically remained stable due to its entrenched position in clinical practice. Growth has been moderate, reflecting organic market expansion rather than aggressive marketing or new indication approvals.

Projected Growth Drivers

  • Emerging Markets: Rapid expansion in regions like Asia-Pacific, Latin America, and Africa, driven by improvements in healthcare access.

  • Product Line Expansion: Potential formulation innovations, such as preservative-free or combination products, may enhance appeal.

  • Increased Demand for Over-the-Counter (OTC) Options: Reclassification for OTC sales in certain jurisdictions could expand consumer access.

Potential Revenue Streams

  • Patent-Related Sales: Exclusive formulations or delivery mechanisms.

  • Regulatory Approvals for New Indications: Extending usage scope.

  • Partnerships and Licensing: Collaborations for distribution and co-development.

Forecast Estimates (2023-2028)

Industry analysts project a compound annual growth rate (CAGR) of approximately 3%-5% for POLYTRIM’s market segment, considering current trends. The primary growth will stem from emerging markets and incremental formulation improvements. However, the threat of generic erosion and resistance development could moderate growth prospects.


Competitive Landscape

The market features a mix of branded and generic antimicrobials, including mupirocin, fusidic acid, and other polymyxin derivatives. Competition hinges on efficacy, safety, price, and brand recognition. POLYTRIM maintains competitive advantage through proven clinical data and established brand presence, yet must innovate to sustain growth amidst commoditization pressures.


Regulatory and Innovation Outlook

Regulatory Focus: Emphasis on antimicrobial stewardship means rigorous evaluation of both efficacy and safety profiles. Future approvals may require demonstrating no contribution to resistance and acceptable safety margins.

Innovations: Nanotechnology encapsulation, combination therapies, and novel delivery systems could enhance POLYTRIM’s effectiveness and usability, potentially expanding indications.


Conclusion

The market dynamics for POLYTRIM are shaped by a complex interplay of clinical needs, resistance patterns, regulatory landscapes, and competitive forces. While current demand sustains moderate growth, future trajectories hinge on innovation, geographic expansion, and strategic positioning against generic and emerging competitors. To maximize its financial potential, stakeholders should focus on formulation advancements, stewardship initiatives, and expanding access in underserved regions.


Key Takeaways

  • Steady demand persists due to bacterial infection prevalence, but growth is constrained by resistance and generic competition.
  • Emerging markets offer significant growth opportunities through healthcare infrastructure development.
  • Innovation in formulations and expanding indications could enhance revenue streams.
  • Resistance management remains critical; failure to address AMR could threaten long-term market viability.
  • Regulatory navigation and stewardship programs will shape future market access and profitability.

FAQs

1. How does antimicrobial resistance impact POLYTRIM’s market viability?
Rising resistance levels, particularly to polymyxins and trimethoprim, threaten POLYTRIM's efficacy, potentially reducing its clinical utility and market share unless formulations evolve or new indications are developed.

2. What are the main competitors for POLYTRIM?
Key competitors include topical antibiotics like mupirocin, fusidic acid, and generic polymyxin-based products. These alternatives often compete on efficacy, price, and formulary inclusion.

3. Can POLYTRIM expand beyond topical applications?
Currently, no; however, research into new delivery systems or combination therapies could facilitate future indication expansion, possibly into systemic or ophthalmic use.

4. How do regulatory changes influence POLYTRIM’s market?
Stricter antimicrobial regulations emphasizing safety and stewardship could limit certain uses or require additional clinical trials, impacting sales and market access.

5. What strategies can pharmaceutical companies adopt to sustain POLYTRIM’s competitiveness?
Innovations in drug delivery, expanding indications, geographical expansion, and proactive stewardship can preserve or enhance its market position amid evolving challenges.


Sources

[1] Market research reports on antimicrobial topical agents.
[2] FDA and EMA approval documents for polymyxin-based therapies.
[3] WHO antimicrobial resistance updates and guidelines.
[4] Industry forecasts and analytics from pharmaceutical market intelligence firms.

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