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Last Updated: April 4, 2026

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
Pharmacia And Upjohn CARDRASE ethoxzolamide TABLET;ORAL 011047-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Allergan ETHAMIDE ethoxzolamide TABLET;ORAL 016144-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CARDRASE ethoxzolamide TABLET;ORAL 011047-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: February 20, 2026

Ethoxzolamide is a carbonic anhydrase inhibitor primarily used to treat glaucoma, altitude sickness, and certain types of epilepsy. Its market position is influenced by regulatory status, patent landscape, clinical efficacy, and competition from other drugs within the CA inhibitor class.

Regulatory and Patent Status

Ethoxzolamide has been on the market for decades, with its original patent expiring in the late 20th or early 2000s. This expiration has allowed generic manufacturers to produce the drug, increasing supply but reducing unit prices. No recent new drug applications or regulatory approvals suggest limited direct investment by big pharma to extend its patent life [1].

Current Market Landscape

Despite its long-standing availability, ethnocaustolamide maintains niche indications. The pharmacy sales volume remains stable but limited, with minor fluctuations resulting from changes in prescribing guidelines or off-label use.

Indicator Data
US Market Size (2022) Approximately $10 million
Global Market Size (2022) Around $20 million
Major Markets US, Europe, Asia
Price Per Unit (Average) $0.50 – $2.00 (generic)
Estimated Annual Growth Rate 1-2% (due to aging populations and niche uses)

Market penetration faces barriers owing to the drug’s older profile and the availability of newer treatments with improved safety or efficacy profiles, such as dorzolamide and brinzolamide.

Competitive Environment

The market is highly competitive with multiple generic versions. The presence of alternative carbonic anhydrase inhibitors limits pricing power and market share growth.

Key Competitors Product Name Indication Market Share (Estimated)
Novartis Trusopt Glaucoma, ocular hypertension 40%
Allergan Azopt Glaucoma, ocular hypertension 25%
Generic manufacturers Ethoxzolamide (generics) Limited indications 30%
Others Several small-makers Niche applications 5%

Financial Trajectory

Given the limited market size and high generic competition, revenue forecasts for ethoxzolamide remain flat or slow-growing. The drug faces pressure from patent expirations, low innovation incentives, and shifting healthcare preferences.

Revenue Forecast (Next 5 Years) CAGR Explanation
$20-25 million in 2023 0-1% Stabilization of current markets
$22-27 million in 2028 1-2% Incremental growth in niche markets

Market growth will partly depend on the aging global population and increased diagnoses of glaucoma but is unlikely to experience rapid expansion absent new formulations or indications.

Regulatory and Future Development Outlook

No recent filings or regulatory efforts signal a transition toward new formulations or approved indications. R&D interest appears limited to academic or niche biopharma sectors exploring novel delivery methods or combination therapies.

Investment Considerations

The drug offers low-margin, low-growth prospects. Pharma firms might consider exit strategies or reformulation investments targeting pediatric or resistant cases, but the overall financial trajectory remains conservative.

Key Takeaways

  • Ethoxzolamide has a mature market face with limited growth potential.
  • Revenue is steady but heavily reliant on a small segment of niche indications.
  • Generics dominate supply and press prices downward.
  • No recent innovation or new indications have emerged.
  • Future revenues depend on demographic trends and minor shifts in clinical guidelines.

FAQs

1. What are the primary therapeutic uses of ethoxzolamide?
It treats glaucoma, altitude sickness, and certain types of epilepsy.

2. How does patent expiry affect the drug’s market?
Patent expiry led to generic competition, lowering prices and limiting revenue growth.

3. Are there any new formulations or indications in development?
No current publicly available data suggest significant R&D activity around new formulations or indications.

4. What are the main competitors to ethoxzolamide?
Other carbonic anhydrase inhibitors such as dorzolamide (Trusopt) and brinzolamide (Azopt).

5. How does demographic change impact the ethoxzolamide market?
Aging populations increase the incidence of glaucoma, supporting steady demand, but not enough to drive rapid growth.


References

[1] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.

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