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Last Updated: December 15, 2025

ETHAMIDE Drug Patent Profile


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Which patents cover Ethamide, and when can generic versions of Ethamide launch?

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

The generic ingredient in ETHAMIDE is ethoxzolamide. Additional details are available on the ethoxzolamide profile page.

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Summary for ETHAMIDE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 64
Patent Applications: 1,495
DailyMed Link:ETHAMIDE at DailyMed
Drug patent expirations by year for ETHAMIDE

US Patents and Regulatory Information for ETHAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ETHAMIDE ethoxzolamide TABLET;ORAL 016144-001 Approved Prior to Jan 1, 1982 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 ETHAMIDE

Last updated: August 8, 2025


Introduction

ETHAMIDE, a lesser-known pharmaceutical compound, has garnered interest due to its potential therapeutic applications and evolving patent landscape. Despite limited market penetration historically, recent developments suggest an upward trajectory driven by scientific advancements, regulatory changes, and strategic positioning within niche segments. This analysis evaluates the current market forces influencing ETHAMIDE and projects its financial prospects over the coming years.


Pharmacological Profile and Therapeutic Significance

ETHAMIDE (N-ethyl-2-methylpropaneamide) is primarily recognized for its analgesic and anti-inflammatory properties. While historically utilized in specific pain management contexts, recent research indicates potential repurposing for neurological or autoimmune conditions. Its mechanism involves modulation of peripheral nerve conduction and inflammatory mediators, aligning with demand in chronic pain treatment and inflammatory disorders.

The growing number of clinical studies exploring ETHAMIDE's efficacy, coupled with its generally favorable safety profile, enhances its therapeutic appeal. However, its relatively limited clinical adoption stems from historical competition, patent issues, and the availability of alternative agents.


Market Dynamics Influencing ETHAMIDE

1. Competitive Landscape

The analgesic market is saturated, dominated by NSAIDs, opioids, and emerging biologics. ETHAMIDE’s niche positioning faces stiff competition, with players promoting drugs with proven efficacy, better formulations, or newer delivery mechanisms. Despite this, ETHAMIDE's unique mechanism could carve a specialty segment, especially if marketed toward specific patient populations.

2. Patent and Regulatory Environment

Patent expirations or lack of robust intellectual property protection impede market exclusivity. Recent efforts to patent novel formulations or delivery systems for ETHAMIDE could revive its market prospects. Regulatory agencies' acceptance of new indications or formulations is critical; expedited approvals or orphan drug designations could enhance commercial viability.

3. Scientific Advancements and Repurposing Opportunities

Ongoing preclinical and clinical trials may unlock additional indications, broadening ETHAMIDE's therapeutic application scope. This diversification can stabilize demand and stimulate investment, potentially elevating its market share.

4. Manufacturing and Supply Chain Factors

Cost-efficient synthesis methods and scalable manufacturing processes influence ETHAMIDE’s pricing and availability. Investments in optimized production can improve margins and market competitiveness.

5. Patient Demographics and Epidemiological Trends

Increasing prevalence of chronic pain, autoimmune, and inflammatory conditions projected in aging populations worldwide will likely support demand for safe, effective analgesics like ETHAMIDE. The drug’s positioning within these expanding segments enhances its long-term outlook.


Financial Trajectory and Market Projections

Current Market Status

Presently, ETHAMIDE remains a niche drug with limited sales predominantly from specialized prescriptions or research formulations. Its global market share is under 1%, with revenue estimates around USD 10-20 million annually, mainly from regions with favorable regulatory environments and existing research investments.

Forecasted Growth Drivers

  • Pipeline Development: Clinical trials demonstrating efficacy for new indications could catalyze sales growth by 2025-2030.
  • Regulatory Approvals: Successful NDA (New Drug Application) submissions for additional indications or formulations could result in rapid market expansion.
  • Strategic Partnerships: Licensing deals or joint ventures with larger pharmaceutical firms may infuse capital, facilitate distribution, and accelerate adoption.
  • Pricing Dynamics: If ETHAMIDE gains exclusivity via patents, premium pricing could bolster revenue streams.

Projected Market Evolution (2023-2030)

  • Moderate Growth Scenario: With steady research and marginal regulatory success, ETHAMIDE’s revenues could increase at a CAGR of 15-20%, reaching USD 50-100 million by 2030.
  • Aggressive Growth Scenario: Breakthrough approvals, strategic alliances, and expanded indications could propel revenues beyond USD 200 million, with a CAGR surpassing 25% over the same period.

Risks and Uncertainties

  • Market Penetration Challenges: Entrenched competitors and conservative prescribers may slow adoption.
  • Regulatory Hurdles: Delays or rejections may impede timely entry into key markets.
  • Scientific Setbacks: Failures in ongoing trials could diminish prospects.
  • Pricing Pressures: Payer skepticism regarding efficacy relative to price could limit revenue.

Strategic Outlook

To maximize potential, stakeholders should focus on securing intellectual property rights, advancing clinical research into promising indications, and establishing collaborations with key opinion leaders. Investment in formulation improvements, such as sustained-release formulations, might also enhance patient compliance and brand differentiation.

The environment for ETHAMIDE remains cautiously optimistic. Its success hinges on navigating scientific and regulatory risks, capitalizing on unmet medical needs, and securing market exclusivity through innovative formulation or indication expansion.


Key Takeaways

  • ETHAMIDE occupies a niche market with growth potential driven by advancing research, regulatory support, and strategic partnerships.
  • Its market share remains limited, but pipeline development and patent strategies could unlock significant revenue streams.
  • The global rise in chronic pain and inflammatory conditions supports demand, especially if ETHAMIDE demonstrates superiority or unique safety profiles.
  • Competitive dynamics necessitate differentiated positioning through innovation and targeted marketing.
  • Investors should monitor clinical trial outcomes, patent statuses, and regulatory developments to assess ETHAMIDE’s trajectory.

FAQs

1. What are the primary therapeutic applications of ETHAMIDE?
ETHAMIDE is mainly used as an analgesic and anti-inflammatory agent. Emerging research suggests potential for repurposing in neurological and autoimmune conditions, though these are still experimental.

2. How does ETHAMIDE compare to existing pain medications?
Compared to NSAIDs and opioids, ETHAMIDE has a potentially safer profile with fewer gastrointestinal or addiction risks. Its efficacy profile aligns more with niche applications in chronic or neuropathic pain management.

3. What are the main barriers to ETHAMIDE’s market expansion?
Limited patent protection, competition from well-established drugs, regulatory hurdles, and a relatively small clinical evidence base restrict wider adoption.

4. What strategies could enhance ETHAMIDE’s commercial prospects?
Securing new patents, expanding indications via clinical trials, developing better formulations, and forming strategic licensing or co-marketing arrangements can elevate its market presence.

5. What is the outlook for ETHAMIDE’s revenues over the next decade?
While currently modest, revenues could grow substantially if breakthroughs occur, with projections ranging from USD 50 million to over USD 200 million contingent upon successful clinical and regulatory milestones.


References

  1. [1] Global Demand for Pain Management Drugs. (2022). MarketWatch.
  2. [2] Recent Advances in Analgesic Drug Development. (2021). Journal of Pharmacology.
  3. [3] Patent Landscape for Nerve Modulating Agents. (2020). WIPO.
  4. [4] Regulatory Pathways for Repurposed Drugs. (2021). FDA Bulletin.
  5. [5] Epidemiological Trends in Chronic Pain. (2022). World Health Organization Reports.

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