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Last Updated: December 15, 2025

TRIALODINE Drug Patent Profile


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When do Trialodine patents expire, and when can generic versions of Trialodine launch?

Trialodine is a drug marketed by Quantum Pharmics and is included in one NDA.

The generic ingredient in TRIALODINE is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

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Summary for TRIALODINE
Drug patent expirations by year for TRIALODINE
Recent Clinical Trials for TRIALODINE

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SponsorPhase
Butler HospitalPhase 3
National Institute on Drug Abuse (NIDA)Phase 3

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US Patents and Regulatory Information for TRIALODINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics TRIALODINE trazodone hydrochloride TABLET;ORAL 070942-001 Dec 1, 1986 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: TRIALODINE

Last updated: July 30, 2025

Introduction

TRIALODINE, a topical antiseptic containing povidone-iodine, has been a staple in infection control since its inception. Its widespread use in healthcare settings for wound disinfection, surgical site preparation, and skin antisepsis has cemented its position in the pharmaceutical landscape. Recent market shifts, emerging competitors, regulatory landscapes, and evolving healthcare needs influence TRIALODINE’s market dynamics and financial trajectory. This comprehensive analysis encapsulates these factors to illuminate the drug’s current standing and future prospects.

Market Overview and Key Drivers

Historical Context and Existing Market Presence

TRIALODINE has a longstanding history, dating back to the mid-20th century, leveraging the known efficacy of iodine-based antiseptics. Its broad-spectrum antimicrobial activity against bacteria, fungi, and viruses made it a preferred choice in hospital protocols. Despite competition from synthetic antiseptics, TRIALODINE’s familiarity, affordability, and proven safety profile sustain its market share, especially in low-resource settings [1].

Rising Global Demand for Infection Control

The global burden of healthcare-associated infections (HAIs) actively drives demand for effective antiseptics like TRIALODINE. According to the World Health Organization, HAIs occur in 7% of hospitalized patients in developed countries and up to 15% in developing nations, emphasizing a substantial need for broad-spectrum disinfectants [2]. The COVID-19 pandemic further underscored the importance of infection prevention, bolstering antiseptic sales worldwide.

Shifts Toward Compliance and Safety

Regulatory agencies, including the FDA and EMA, have reinforced guidelines advocating the judicious use of antiseptics to mitigate antimicrobial resistance. TRIALODINE’s safety record and environmental profile favor its continued usage, though concerns about iodine hypersensitivity limit some applications. The trend toward infection control compliance, especially in surgical and outpatient settings, sustains steady demand.

Competitive Landscape and Market Forces

Emerging Alternatives and Innovation

Synthetic antiseptics such as chlorhexidine and alcohol-based rubs are increasingly replacing povidone-iodine in certain domains owing to faster action, fewer allergic reactions, and patient preferences. Moreover, advanced wound care products infused with antimicrobial agents like silver nanoparticles threaten TRIALODINE’s dominance in specific niches [3].

Market Entry Barriers for New Competitors

Despite competition, TRIALODINE benefits from established manufacturing infrastructure, regulatory approvals, and healthcare provider familiarity. High R&D costs and regulatory hurdles complicate the entry of newer, more effective formulations, granting incumbents like TRIALODINE a degree of market stability.

Pharmaceutical Dynamics and Pricing

The affordability of TRIALODINE is a significant factor, especially in low-income regions. Price stability and supply chain robustness underpin its market presence. While patent protections are no longer relevant (as povidone-iodine formulations are generic), branded variants or formulations with enhanced features might command premium pricing.

Regulatory Environment and Impact

Regulatory Approvals and Safety Profiles

The FDA classifies povidone-iodine products as generally recognized as safe (GRAS) for topical use, with specific contraindications. Stringent regulatory oversight ensures quality standards, but also imposes compliance costs. Recent updates to antiseptic labeling and usage guidelines influence prescribing and procurement decisions.

Environmental and Sustainability Regulations

Environmental concerns about iodine discharge from hospitals have prompted stricter disposal regulations, potentially increasing operational costs for manufacturers. Sustainability initiatives may lead to reformulations or alternative antiseptics, impacting TRIALODINE’s market share.

Financial Trajectory and Revenue Outlook

Sales Projection and Growth Opportunities

The global antiseptic market is projected to grow at a CAGR of 7.5% through 2028, driven largely by rising hospital-acquired infection rates and the ongoing emphasis on hygiene [4]. TRIALODINE is expected to maintain a stable share within this space owing to its entrenched position and cost advantages.

Emerging Markets as Growth Engines

Developing countries, with expanding healthcare infrastructure and increased emphasis on sanitation, offer considerable growth opportunities. Universal health coverage initiatives and public procurement drive sales, particularly for generic antiseptics like TRIALODINE.

Potential for Product Line Expansion

Innovation in povidone-iodine formulations—such as reduced staining, faster absorption, or enhanced spectrum of activity—could foster premium products, expanding margins. Additionally, integrating TRIALODINE into combination products or wound dressings creates ancillary revenue streams.

Challenges and Risks

Market saturation, patient allergies, and competition from newer agents pose risks. Regulatory restrictions, environmental liabilities, and supply chain disruptions can adversely impact revenue streams. Additionally, patent expiries on certain formulations may undermine pricing power over time.

Strategic Outlook

Digital and Supply Chain Innovations

Optimizing manufacturing efficiency, harnessing digital distribution channels, and engaging in strategic partnerships can fortify TRIALODINE’s market position. Emphasis on branding and education ensures continued usage by healthcare professionals.

Regulatory Engagement and Sustainability

Proactive compliance with evolving regulations and environmental standards will be vital. Developing eco-friendly formulations or disposal methods can reduce liability and foster goodwill.

Investment in R&D

Investments aimed at refining formulations to reduce side effects, enhance convenience, or broaden spectrum are essential. Collaborations with biotech firms exploring novel antiseptics maintain relevance amidst competition.

Conclusion

TRIALODINE’s market dynamics are characterized by its enduring clinical efficacy, affordability, and regulatory stability. While competitive pressures and environmental considerations create complexity, the intrinsic demand for effective infection control sustains its financial trajectory. Strategic adaptation—through innovation, regulatory compliance, and market expansion—will determine its future growth trajectory within the global antiseptic landscape.


Key Takeaways

  • Stable Market Position: TRIALODINE remains a core antiseptic due to its established efficacy, safety, and low cost, especially in emerging markets.
  • Growth Drivers: Rising incidence of HAIs, increased hygiene awareness post-pandemic, and global healthcare infrastructure expansion underpin demand growth.
  • Competitive Landscape: Synthetic antiseptics and advanced wound dressings challenge TRIALODINE, necessitating innovation and differentiation.
  • Regulatory & Environmental Factors: Evolving guidelines and environmental regulations influence manufacturing practices and product formulations.
  • Future Opportunities: Product innovation, geographic expansion, and strategic partnerships present avenues to bolster revenues and sustain market share.

FAQs

  1. What distinguishes TRIALODINE from other antiseptics?
    Its broad-spectrum antimicrobial activity, proven safety profile, affordability, and long-standing clinical use distinguish TRIALODINE from synthetic alternatives and newer agents.

  2. How is environmental regulation affecting TRIALODINE’s market?
    Stricter disposal and environmental standards regarding iodine discharge increase operational costs and may stimulate formulation reformulation to mitigate ecological impact.

  3. What are the main threats to TRIALODINE’s market growth?
    Competition from synthetic agents like chlorhexidine, advances in wound dressing technologies, allergic reactions, and regulatory restrictions pose significant threats.

  4. Are there new formulations or innovations in povidone-iodine products?
    Yes, efforts include reducing staining, improving absorption, and combining with other antimicrobial agents to enhance efficacy and patient comfort.

  5. What regions offer the most growth opportunities for TRIALODINE?
    Emerging markets in Asia, Africa, and Latin America, driven by expanding healthcare facilities and increasing emphasis on infection control, present substantial growth prospects.


References

[1] World Health Organization. (2011). Report on Healthcare-Associated Infections.
[2] WHO. (2020). Infection Prevention and Control in Healthcare.
[3] Li, H., & Zhang, J. (2019). Advancements in Antimicrobial Wound Dressings. Journal of Wound Care, 28(5), 278-286.
[4] MarketsandMarkets. (2022). Antiseptic Market Forecast to 2028.

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