ACETAZOLAMIDE - Generic Drug Details

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

Acetazolamide is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alembic, Cadila, Heritage Pharma, Indicus Pharma, Micro Labs Ltd India, Mpp Pharma, Novast Labs, Rising, Teva Branded Pharm, Ajanta Pharma Ltd, Alra, Appco, Ascot, Aurobindo Pharma Ltd, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon Research, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Gland, Hikma, Hospira, Mylan Asi, Ph Health, Xgen Pharms, Zydus Pharms, and Teva Womens, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for acetazolamide. Thirty-four suppliers are listed for this compound.

Summary for ACETAZOLAMIDE

US Patents:	0
Tradenames:	3
Applicants:	39
NDAs:	42
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	165
Drug Prices:	Drug price trends for ACETAZOLAMIDE
What excipients (inactive ingredients) are in ACETAZOLAMIDE?	ACETAZOLAMIDE excipients list
DailyMed Link:	ACETAZOLAMIDE at DailyMed

See drug prices for ACETAZOLAMIDE

Recent Clinical Trials for ACETAZOLAMIDE

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

Sponsor	Phase
Sanjay R Patel	PHASE2
National Institute on Drug Abuse (NIDA)	PHASE2
University Hospital, Montpellier	NA

See all ACETAZOLAMIDE clinical trials

Pharmacology for ACETAZOLAMIDE

Drug Class	Carbonic Anhydrase Inhibitor
Mechanism of Action	Carbonic Anhydrase Inhibitors

Medical Subject Heading (MeSH) Categories for ACETAZOLAMIDE

Anticonvulsants

Carbonic Anhydrase Inhibitors

Diuretics

Anatomical Therapeutic Chemical (ATC) Classes for ACETAZOLAMIDE

S01EC	Carbonic anhydrase inhibitors
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ACETAZOLAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon Research	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	215101-001	Aug 19, 2021	AB	RX	No	No
Heritage Pharma	ACETAZOLAMIDE	acetazolamide	CAPSULE, EXTENDED RELEASE;ORAL	040904-001	Dec 10, 2008	AB	RX	No	No
Ne Rx Pharma	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	217197-001	May 9, 2023	AB	RX	No	No

Market Dynamics and Financial Trajectory for Acetazolamide

Last updated: July 27, 2025

Introduction

Acetazolamide, a versatile carbonic anhydrase inhibitor, has long been used in treating glaucoma, altitude sickness, epilepsy, and certain metabolic disturbances. Despite its decades-long presence on the market, recent shifts in pharmaceutical innovation, evolving healthcare policies, and patient-centric treatment paradigms influence its market trajectory. This analysis assesses the current market dynamics and forecasts the financial trajectory of acetazolamide, considering competition, regulatory landscape, patent status, manufacturing, and emerging therapeutic opportunities.

Pharmacological Profile and Therapeutic Applications

Acetazolamide functions by inhibiting carbonic anhydrase enzymes, reducing aqueous humor production, and promoting diuresis. Its primary approved indications include:

• Glaucoma: First-line therapy for reducing intraocular pressure.
• Altitude Sickness: Prevention and treatment, especially at high elevations.
• Epilepsy: Adjunctive therapy for certain seizure types.
• Metabolic Alkalosis & Congenital Heart Conditions: Off-label indications involve acid-base management.

The drug's efficacy, safety profile, and low-cost manufacturing contribute to its longstanding clinical use.

Market Dynamics

1. Competitive Landscape

The market for acetazolamide faces increasing competition from newer pharmacological agents with improved specificity and tolerability. In glaucoma management, prostaglandins (e.g., latanoprost) and beta-blockers (e.g., timolol) have gained dominance over carbonic anhydrase inhibitors like acetazolamide. These alternatives often demonstrate fewer systemic side effects, impacting market share.

Regarding altitude sickness, the advent of newer pharmacological remedies and non-pharmacological interventions (such as gradual ascent protocols) influences demand. For epilepsy, newer antiseizure drugs like levetiracetam or lamotrigine offer improved tolerability, reducing reliance on acetazolamide.

2. Patent Status and Market Exclusivity

Acetazolamide's original patents have expired, resulting in generic manufacturing dominance. The proliferation of low-cost generics diminishes drug pricing power and revenue potential for innovator companies (if any current patent protections exist). Consequently, the financial incentive for substantial R&D investments diminishes, impacting long-term innovation.

3. Regulatory and Reimbursement Factors

Regulatory agencies continue to approve formulations of acetazolamide, with the FDA and EMA maintaining its approved indications. Reimbursement policies favor cost-effective treatments, bolstering its use in resource-limited settings. However, regulatory agencies also push for newer, safer compounds, influencing the drug's market persistence.

4. Manufacturing and Supply Chain

Generic manufacturers dominate production, ensuring a stable supply chain at low costs. However, fluctuations in raw material prices, quality assurance challenges, and manufacturing capacity constraints can influence market availability and pricing.

5. Emerging Therapeutic Applications

Research into novel indications, such as its potential role in managing certain neurodegenerative conditions or in combination therapies for resistant glaucoma, could open additional revenue streams. Nonetheless, such applications remain largely investigational, with limited commercial impact currently.

Financial Trajectory

Historical Performance

Historically, acetazolamide has been a low-margin, high-volume drug, largely driven by its affordability and broad indication spectrum. Its revenues have plateaued due to market saturation and competition. The global market value was estimated at approximately USD 200-300 million annually, heavily weighted toward emerging markets where cost-effectiveness determines usage (1).

Projected Trends (Next 5–10 Years)

• Stable Position in Off-Patent Markets: Given its low-cost production, acetazolamide will likely retain a steady revenue stream in developing economies, especially where healthcare expenditure is constrained.
• Gradual Decline in Developed Markets: Adoption of newer agents with better safety profiles, patent expirations, and formulary shifts will erode market share.
• Potential for Niche and Investigational Use: If future research substantiates novel indications, market revenues could experience incremental growth, though unlikely to surpass current levels significantly.
• Impact of Biosimilars and Generics: Increased competition will suppress pricing, further constraining profit margins (2).

Forecast Summary

Factor	Impact on Revenue	Outlook
Competition (existing drugs)	Negative	Likely decline
Patent expiries	Negative	Revenue stabilization at low levels
Emerging indications	Potential positive for niche markets	Uncertain, long-term
Regulatory environment	Neutral to slightly positive	Continued approval, minimal growth
Manufacturing cost trends	Neutral	Stable supply, low costs

In sum, acetazolamide's financial position is poised for marginal stability in traditional markets, with limited growth prospects absent new indications or formulations.

Strategic Considerations

• Opportunities for Differentiation: Developing novel formulations, such as targeted delivery systems or combination products, could preserve market relevance.
• Expanding Usage in Developing Markets: Continued cost-effectiveness may sustain demand, especially in resource-limited healthcare systems.
• Investment in Research: Further clinical investigations might unlock secondary indications, opening new revenue channels.

Key Takeaways

• Acetazolamide faces saturation and declining market share in developed countries, driven by competition from newer agents.
• Its low-cost generics dominate in emerging markets, maintaining a steady, albeit modest, revenue stream.
• Patent expiration and patent cliffs suppress pricing power, limiting profit potential.
• Emerging research offers limited short-term growth, with significant dependance on future clinical validation.
• Strategic focus on formulation innovation, market expansion in resource-limited settings, and exploring new therapeutic uses could sustain or enhance its financial trajectory.

FAQs

Q1: Will acetazolamide become obsolete in the next decade?
A1: Not entirely. While competition and newer drugs may reduce its use in some indications, its affordability and established efficacy ensure continued application, especially in developing markets.

Q2: Are there any patent protections left for acetazolamide?
A2: No. The original patents have expired, leading to widespread generic manufacturing and decreased development incentives.

Q3: What emerging research could impact acetazolamide’s market?
A3: Investigations into supplementary indications such as neuroprotection or metabolic regulation could create niche markets, but these are currently in early stages.

Q4: How does the pricing of generics influence acetazolamide's market?
A4: Low pricing, driven by numerous generic producers, limits profit margins but sustains high-volume demand, particularly in low-resource countries.

Q5: Can innovation extend acetazolamide’s market life?
A5: Possibly. Novel delivery methods, combination drugs, or new therapeutic indications could rejuvenate interest but require significant R&D investment and validation.

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References

1. Market Research Future. "Global Acetazolamide Market Report 2022".
2. IMS Health. "Generic Drug Competition and Pricing dynamics", 2021.