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Last Updated: March 25, 2026

Methazolamide - Generic Drug Details


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What are the generic drug sources for methazolamide and what is the scope of patent protection?

Methazolamide is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Anda Repository, Ani Pharms, Applied Anal, Athem, Bausch And Lomb Inc, Chartwell Rx, Tagi, and Lederle, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for methazolamide. Nine suppliers are listed for this compound.

Summary for methazolamide
Drug Prices for methazolamide

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Recent Clinical Trials for methazolamide

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

SponsorPhase
University of WaterlooPhase 4
Wilderness Medical SocietyPhase 4
University of British ColumbiaPhase 4

See all methazolamide clinical trials

Medical Subject Heading (MeSH) Categories for methazolamide

US Patents and Regulatory Information for methazolamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Athem METHAZOLAMIDE methazolamide TABLET;ORAL 040102-001 Aug 28, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ani Pharms METHAZOLAMIDE methazolamide TABLET;ORAL 040001-002 Jun 30, 1993 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Applied Anal METHAZOLAMIDE methazolamide TABLET;ORAL 040011-002 Jul 17, 1997 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

Methazolamide Market Analysis and Financial Projection

Last updated: February 9, 2026

What are the current market dynamics for methazolamide?

Methazolamide is a carbonic anhydrase inhibitor primarily used for glaucoma management and altitude sickness prevention. It faces limited but stable demand driven by ophthalmology and specific niche applications. The global market for carbonic anhydrase inhibitors, including methazolamide, is valued at an estimated $180 million in 2022, projected to grow at a compound annual growth rate (CAGR) of roughly 4% through 2027 (MarketWatch, 2023).

Key market drivers include:

  • Ophthalmic indications: Increasing prevalence of glaucoma, projected to affect over 96 million worldwide by 2025 (WHO, 2019).
  • Altitude sickness: Use in travelers and high-altitude workers remains stable.
  • Drug cost and patent status: Methazolamide's generic status supports stable pricing, constraining rapid revenue growth but maintaining consistent market share.

Market challenges encompass:

  • Availability of alternatives: Drugs like acetazolamide and dorzolamide compete for similar indications.
  • Regulatory environment: Variability in approval status across regions.
  • Patent expirations: Existing patents for related drugs have expired, increasing generic competition.

How is the supply and manufacturing landscape structured?

Methazolamide is produced by several generic manufacturers primarily in India, China, and Eastern Europe. Limited production capacity and patent barriers exclude its inclusion in major branded portfolios. Manufacturing costs are low, estimated at $0.10–0.20 per tablet.

Supply chain issues have been minimal but are sensitive to:

  • Regulatory compliance: GMP standards influence production.
  • Raw material availability: Critical starting materials face supply constraints in some regions.

What is the current financial trajectory for methazolamide?

Sales figures remain modest but consistent:

  • Global sales: Estimated at $150–180 million in 2022.
  • Market share: Dominated by generic manufacturers, with no significant branded presence.
  • Pricing: Average retail price per tablet hovers around $0.05–0.15, reflecting generic competition.

Financial forecasts suggest:

  • Revenue stability**: Expected through 2027 due to consistent demand for glaucoma and altitude sickness applications.
  • Growth potential: Limited unless new indications emerge or patent protections are regained via new formulations or delivery methods.

Research investments are minimal, with ongoing generics-focused manufacturing and some projects exploring formulations with improved bioavailability. No major pharmaceutical company currently has a marketed novel drug based on methazolamide.

How might regulatory and patent landscapes impact future market dynamics?

  • Patent expiry: Most patents, if any, for methazolamide have expired or are nearing expiration, facilitating generic entry.
  • Regulatory approvals: Variance in approvals limits aggressive marketing. Many regions classify methazolamide as off-patent and over-the-counter, influencing sales channels.
  • Potential for new formulations: Patent or exclusivity periods for new delivery forms could provide growth, but such initiatives are rare.

What are potential growth pathways and industry key players?

Growth pathways include:

  • Expansion into new geographic markets with increasing ophthalmic needs.
  • Development of combination formulations, e.g., with beta-blockers.
  • Introduction of sustained-release formulations or alternative delivery systems.

Major players:

  • Sun Pharmaceutical Industries
  • Torrent Pharmaceuticals
  • Zydus Pharmaceuticals
  • Wockhardt Ltd.

These companies dominate generic production, with limited involvement in innovation.

Summary

Methazolamide's market remains stable, driven by longstanding indications and generic competition. Its manufacturing is concentrated in countries with low production costs. Revenue is forecasted to hold steady unless new formulations or indications emerge, or regulatory shifts create new barriers or opportunities.

Key Takeaways

  • The global market was valued at ~$180 million in 2022, with a CAGR of approximately 4%.
  • Demand driven by glaucoma prevalence and altitude sickness.
  • Market is highly commoditized, with limited growth avenues.
  • Generics dominate production; few recent innovations.
  • Regulatory and patent landscapes favor continued generic stability.

FAQs

1. What are the main medical indications for methazolamide?
Primarily used for glaucoma management and altitude sickness prevention.

2. Which regions drive the demand for methazolamide?
North America, Europe, and emerging markets like India and China.

3. Are there ongoing R&D efforts to improve methazolamide formulations?
Limited R&D exists primarily focused on delivery systems; no major innovative drugs are in late-stage development.

4. How does the cost structure influence market pricing?
Low manufacturing costs (~$0.10–0.20 per tablet) lead to competitive pricing, mainly in generics markets.

5. What regulatory hurdles might affect future sales?
Regional approval differences and patent expirations enable or restrict market entry of generics and new formulations.


Citations
[1] MarketWatch. (2023). "Global Carbonic Anhydrase Inhibitors Market Report."
[2] WHO. (2019). "Vision Loss and Glaucoma Statistics."

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