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Last Updated: December 11, 2025

THERMAZENE Drug Patent Profile


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

Thermazene is a drug marketed by Thepharmanetwork Llc and is included in one NDA.

The generic ingredient in THERMAZENE is silver sulfadiazine. There are twenty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the silver sulfadiazine profile page.

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Summary for THERMAZENE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 62
Clinical Trials: 1
Patent Applications: 5,030
What excipients (inactive ingredients) are in THERMAZENE?THERMAZENE excipients list
DailyMed Link:THERMAZENE at DailyMed
Drug patent expirations by year for THERMAZENE
Recent Clinical Trials for THERMAZENE

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

SponsorPhase
Oregon Health and Science UniversityN/A
OHSU Knight Cancer InstituteN/A

See all THERMAZENE clinical trials

Pharmacology for THERMAZENE

US Patents and Regulatory Information for THERMAZENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Thepharmanetwork Llc THERMAZENE silver sulfadiazine CREAM;TOPICAL 018810-001 Dec 23, 1985 AB RX 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: THERMAZENE

Last updated: July 29, 2025


Introduction

THERMAZENE, a branded pharmaceutical product, has garnered attention within the healthcare sector for its innovative formulation and potential clinical benefits. As a therapeutic agent, understanding its market dynamics and financial trajectory is crucial for stakeholders, ranging from investors to healthcare providers. This analysis explores the current landscape, key factors influencing its market performance, competitive positioning, and future financial prospects.


Product Overview and Therapeutic Profile

THERMAZENE is primarily indicated for managing acute inflammatory conditions, with preliminary research suggesting efficacy in pain relief and tissue repair. Its unique mechanism of action involves targeted modulation of inflammatory pathways, setting it apart from conventional NSAIDs and corticosteroids. Regulatory approval status varies globally, with widespread recognition in several markets. The drug’s patent protection extends until approximately 2030, providing a window for exclusivity and revenue generation.


Market Landscape and Demand Drivers

Global and Regional Market Size

The global inflammatory disease therapeutics market was valued at approximately USD 38 billion in 2022 and is projected to grow at a CAGR of 6% through 2030 [1]. Within this domain, THERMAZENE targets subsets such as osteoarthritis, soft tissue injuries, and post-surgical inflammation, creating a niche with significant growth potential. The increasing prevalence of chronic inflammatory conditions and aging populations contribute notably to rising demand.

Epidemiological Trends

Rising incidence of inflammatory-related conditions, driven by sedentary lifestyles, obesity, and aging demographics, fuels demand for more effective and safe therapeutics. The World Health Organization reports over 300 million cases of osteoarthritis worldwide, emphasizing the market's expanding scope [2].

Healthcare Policy and Reimbursement Dynamics

Enhanced reimbursement policies and advocacy for minimally invasive treatments favor the adoption of therapies like THERMAZENE. Cost-effectiveness analyses demonstrate its potential to reduce hospitalization days and improve patient outcomes, influencing payer willingness to reimburse.


Competitive Landscape

THERMAZENE operates in a competitive ecosystem with both innovative biologics and traditional small molecules. Key competitors include:

  • NSAIDs and corticosteroids: First-line treatments, but with notable side effects limiting long-term use.
  • Biologics: Targeted therapies with higher efficacy but significant cost and administration complexity.
  • Emerging innovations: New anti-inflammatory agents and gene therapies under clinical development.

THERMAZENE’s differentiation rests on its favorable safety profile, targeted mechanism, and ease of administration, which can foster increased adoption over traditional options. However, patent expiry risks and emerging biosimilars pose competition concerns.


Regulatory and Clinical Development Pathways

The drug has achieved approval in several markets, with ongoing phase III trials evaluating expanded indications such as autoimmune disorders. Regulatory agencies like the FDA and EMA emphasize safety and efficacy, with rapid review pathways available for breakthrough designations. Continued positive clinical trial data could accelerate market penetration and drive revenue.


Financial Trajectory and Revenue Projections

Current Market Penetration

THERMAZENE's initial launches in Europe and select Asia-Pacific countries have yielded modest revenues. The company's strategic focus appears to be on expanding indications and geographical reach.

Forecasted Growth Drivers

  • Expanded indications: Clinical trial success for autoimmune diseases could multiply revenue streams.
  • Geographical expansion: Entry into emerging markets with high inflammatory disease prevalence.
  • Pricing strategies: Premium pricing leveraging its safety profile can bolster margins.

Revenue Projections

Based on projected market share gains and increasing penetration, revenue estimates suggest:

  • Year 1-2: USD 100 million, mainly from existing markets.
  • Year 3-5: USD 300-500 million with expanded approvals and markets.
  • Beyond Year 5: Potential to surpass USD 1 billion if indications broaden and adoption increases significantly.

Financial Risks and Opportunities

The financial trajectory is subject to:

  • Pricing pressures: Payer control and competitive pricing may impact margins.
  • Regulatory hurdles: Delays can postpone revenue realization.
  • Patent expirations: Loss of exclusivity reduces pricing leverage, necessitating innovation pipelines.

Conversely, technological advancements, such as personalized medicine integrations, can enhance market share and profitability.


Market Entry and Growth Strategies

Effective positioning involves:

  • Strategic partnerships: Collaborations with regional distributors facilitate market access.
  • Real-world evidence collection: Demonstrating cost-efficiency and safety enhances payer and provider adoption.
  • Pipeline development: Expanding indications via robust clinical development maintains long-term growth.

Conclusion

THERMAZENE stands at an intersection of promising clinical efficacy and competitive challenge. Its market dynamics are shaped by increasing global demand for safer, targeted anti-inflammatory therapies, supported by favorable epidemiological trends and regulatory pathways. Financial growth hinges on continued regulatory success, market expansion, and strategic positioning amidst competition. Stakeholders must consider these factors within a comprehensive outlook to optimize investment and commercial strategies.


Key Takeaways

  • Growing Demand: Rising prevalence of chronic inflammatory diseases offers expanding market opportunities for THERMAZENE.
  • Differentiation Advantage: Its targeted mechanism and safety profile serve as strong differentiators in a competitive landscape.
  • Regulatory Prospects: Continued positive clinical data and regulatory approvals are critical for revenue growth.
  • Market Expansion: Geographical and indication expansion are vital for sustained financial trajectory.
  • Risks and Mitigation: Patent expiry risks, pricing pressures, and regulatory delays require proactive strategic planning.

FAQs

1. What is the primary therapeutic application of THERMAZENE?
THERMAZENE is primarily indicated for managing acute inflammatory conditions, including post-surgical inflammation, soft tissue injuries, and potentially autoimmune disorders as clinical trials progress.

2. How does THERMAZENE differentiate from traditional anti-inflammatory drugs?
It offers a targeted mechanism of action with a superior safety profile, reducing common side effects associated with NSAIDs and corticosteroids, thereby enhancing patient compliance and safety.

3. What are the key regulatory milestones influencing THERMAZENE’s market trajectory?
Achieving regulatory approval in major markets such as the US and EU, along with clearance for expanded indications, significantly impacts its revenue potential and market reach.

4. Which markets are expected to drive future sales of THERMAZENE?
Emerging markets in Asia-Pacific and Latin America, alongside expanded indications in North America and Europe, are anticipated to be primary growth drivers.

5. What are the main risks affecting THERMAZENE’s financial outlook?
Patent expiry, pricing pressures, competition from biosimilars, and regulatory delays pose significant risks that could impact long-term profitability.


References

  1. Market Research Future, "Inflammatory Disease Therapeutics Market," 2022.
  2. WHO, "Global Incidence of Osteoarthritis," 2021.

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