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Last Updated: December 14, 2025

ETHOXZOLAMIDE - Generic Drug Details


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What are the generic drug sources for ethoxzolamide and what is the scope of freedom to operate?

Ethoxzolamide is the generic ingredient in two branded drugs marketed by Pharmacia And Upjohn and Allergan, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ETHOXZOLAMIDE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 65
DailyMed Link:ETHOXZOLAMIDE at DailyMed
Medical Subject Heading (MeSH) Categories for ETHOXZOLAMIDE

US Patents and Regulatory Information for ETHOXZOLAMIDE

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
Pharmacia And Upjohn CARDRASE ethoxzolamide TABLET;ORAL 011047-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn CARDRASE ethoxzolamide TABLET;ORAL 011047-002 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 Ethoxzolamide

Last updated: July 31, 2025

Introduction

Ethoxzolamide, a carbonic anhydrase inhibitor primarily used to treat glaucoma, metabolic alkalosis, and certain epileptic conditions, resides within a niche segment of the pharmaceutical landscape. As a longstanding therapeutic agent, its market parameters are influenced by evolving clinical practices, patent statuses, regulatory changes, and emerging competitors. This report evaluates the current market environment, projected financial trajectory, and strategic considerations relevant to stakeholders involved in ethoxzolamide’s commercial ecosystem.

Historical and Current Market Context

Ethoxzolamide was first approved decades ago, with its initial formulations publicly available in the mid-20th century. While its clinical utility remains, the advent of newer classes of drugs—such as prostaglandin analogs for glaucoma—has diminished its market share in some indications. Nonetheless, ethoxzolamide retains relevance in certain niche applications, especially where cost considerations and long-term safety profiles favor older, well-established medications.

The global market size for carbonic anhydrase inhibitors, including ethoxzolamide, was valued at approximately USD 300 million in 2022, with an estimated CAGR of around 4% (2023–2028), driven by increasing prevalence of glaucoma and metabolic disorders [1]. Ethoxzolamide constitutes an estimated 15–20% of this segment, with regional variations favoring mature markets like North America and Europe, due to established prescribing habits and regulatory approvals.

Market Drivers

Growing Prevalence of Indications

The rising incidence of glaucoma, attributed to aging populations and increased screening, sustains demand for carbonic anhydrase inhibitors. According to the WHO, glaucoma affects over 76 million people worldwide, with projections exceeding 112 million by 2040 [2]. Ethoxzolamide’s role in lowering intraocular pressure contributes directly to this demand.

Established Safety Profile and Cost-Effectiveness

Compared to newer agents, ethoxzolamide’s long-term safety record and lower costs support its continued use in resource-constrained settings. In developing economies, reliance on older medications remains significant where newer drugs face reimbursement hurdles.

Regulatory Landscape

In the US, ethoxzolamide's patent has long expired, categorizing it as a generic drug. The simplicity of its molecule and manufacturing process supports high market penetration without the barrier of proprietary restrictions. Regulatory bodies like the FDA recognize its established safety profile, facilitating ongoing prescriptions.

Market Challenges

Emergence of New Therapeutics

The pharmaceutical innovation landscape has shifted toward prostaglandin analogs, beta-blockers, and laser surgeries, which often demonstrate superior efficacy and fewer systemic side effects. These innovations reduce ethoxzolamide’s attractiveness, especially in developed markets.

Limited Formulation Innovation

As a drug with minimal recent formulation modifications, ethoxzolamide faces stagnation in innovation-driven growth. Lack of derivative or combination products limits market expansion opportunities.

Regulatory and Patent Discontinuities

Although ethoxzolamide itself is generic, ancillary patent issues regarding combination formulations or new indications could create hurdles or opportunities—either delaying uptake or fostering niche markets.

Financial Trajectory and Strategic Outlook

Market Forecast

Projections indicate modest growth aligned with the broader carbonic anhydrase inhibitor market. By 2028, the global ethoxzolamide market is expected to reach approximately USD 360–400 million, driven by:

  • Growing glaucoma prevalence in emerging markets.
  • Continued use in specific metabolic conditions.
  • Cost-sensitive healthcare settings maintaining demand for older generics.

Emerging Opportunities

  • Niche Indications: Off-label uses such as treatment for certain metabolic alkalosis cases and alternative indications, though limited, offer additional avenues.
  • Combination Therapies: Pairing with other ocular hypotensive agents could enhance efficacy and extend market lifespan.
  • Formulation Improvements: Developing sustained-release or improved bioavailability formulations might appeal to patient compliance and clinician preferences.

Threats and Competitive Landscape

  • Market Share Erosion: As newer therapies become standard, ethoxzolamide’s market share diminishes primarily in developed economies.
  • Price Competition: The generic nature of ethoxzolamide exerts downward pressure on pricing.
  • Regulatory Challenges: Any new safety concerns or regulatory shifts could impact its utilization.

Strategic Considerations

Pharmaceutical companies should evaluate potential growth in emerging markets, where cost-effective, well-established drugs like ethoxzolamide continue to be vital. Strategic efforts might include local manufacturing, education campaigns to promote cost-effective use, and exploring combination formulations.

In contrast, for established players in mature markets, maintaining clinical relevance may involve repositioning or developing labeling for niche indications. Licensing opportunities or partnerships with regional healthcare providers could optimize market penetration.

Conclusion

The ethoxzolamide market exhibits stable, moderate growth primarily driven by demographic trends and its affordability. Nonetheless, the landscape faces significant challenges from therapeutic advancements and evolving clinical practices. Stakeholders should consider targeted strategies emphasizing niche markets, formulation innovations, and regional expansion to capitalize on ethoxzolamide's enduring therapeutic value.


Key Takeaways

  • Ethoxzolamide's market persists as a niche, supported by its safety profile, cost advantages, and established use in glaucoma and metabolic conditions.
  • Market growth aligns with broader carbonic anhydrase inhibitor segments, projected at a compound annual growth rate of around 4% through 2028.
  • Emerging therapies and demographic shifts pose competitive threats, necessitating strategic adaptation for sustained relevance.
  • Regional differences in healthcare infrastructure influence utilization, with developing markets offering growth opportunities.
  • Innovation in formulation and strategic positioning in niche indications can extend ethoxzolamide's financial trajectory.

FAQs

1. What are the main clinical indications for ethoxzolamide today?
Primarily used for glaucoma management, ethoxzolamide reduces intraocular pressure by inhibiting carbonic anhydrase. It also treats metabolic alkalosis and certain epileptic conditions, though its use in epilepsy is less common.

2. How does ethoxzolamide compete with newer therapies in glaucoma?
While effective, ethoxzolamide is generally less favored in developed markets due to newer agents like prostaglandin analogs offering better efficacy and fewer side effects. However, it remains a cost-effective option in resource-limited settings.

3. What are the key market opportunities for ethoxzolamide?
Opportunities lie in expanding use in emerging markets, exploring niche indications, developing improved formulations, and forming partnerships for regional distribution.

4. Are there any patents or regulatory hurdles affecting ethoxzolamide's market?
Being a long-off-patent generic, ethoxzolamide faces minimal patent barriers. Regulatory acceptance remains secure due to its established safety profile.

5. How might future pharmaceutical developments impact ethoxzolamide’s market?
Advances in targeted drug delivery, gene therapy, or new classes of ocular hypotensives could further diminish ethoxzolamide’s market share, underscoring the importance of innovation and strategic niche positioning.


References

[1] MarketResearch.com, "Global Carbonic Anhydrase Inhibitors Market," 2022.
[2] WHO, "World Glaucoma Association Global Prevalence Reports," 2021.

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