Acetazolamide - Generic Drug Details

What are the generic drug 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, Nostrum Labs Inc, Novast Labs, Rising, Teva Branded Pharm, Ajanta Pharma Ltd, Alra, Appco, Ascot, Breckenridge, Chartwell Molecular, Epic Pharma Llc, Hibrow Hlthcare, Mankind Pharma, Ne Rx Pharma, Novitium Pharma, Rubicon, Strides Pharma, Sun Pharm Industries, Taro, Torrent, Vangard, Watson Labs, Zydus Lifesciences, Avet Lifesciences, Endo Operations, Hikma, Hospira, Mylan Asi, Xgen Pharms, Zydus Pharms, and Teva Womens, and is included in forty 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:	37
NDAs:	40
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	147
Patent Applications:	6,989
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
Incannex Healthcare Ltd	Phase 2/Phase 3
Johannes Grand	Phase 4
University of Arizona	Early Phase 1

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
Epic Pharma Llc	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	218023-002	May 14, 2024	AB	RX	No	No
Epic Pharma Llc	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	218023-001	May 14, 2024	AB	RX	No	No
Watson Labs	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	084498-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Molecular	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	084840-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Taro	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	040195-001	May 28, 1997	AB	RX	No	No
Breckenridge	ACETAZOLAMIDE	acetazolamide	TABLET;ORAL	207503-002	Apr 30, 2020		DISCN	No	No

Acetazolamide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Acetazolamide

Market Size and Forecast

The acetazolamide market is poised for significant growth over the coming years. As of 2022, the market size was valued at USD 263.04 billion and is projected to reach USD 499.69 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.60% from 2023 to 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the acetazolamide market:

Increasing Prevalence of Medical Conditions

The demand for acetazolamide is driven by the rising prevalence of medical conditions such as glaucoma, epilepsy, and heart failure. As the global population ages and healthcare access improves, especially in emerging markets, the need for effective treatments for these conditions increases[1][3].

Expansion of Adventure and Travel Industries

Acetazolamide is also used to treat altitude sickness, and the growing adventure and travel industries are expected to boost its demand. This expanded use case adds to the market's growth potential[1].

Advancements in Medical Research

Research and development in the pharmaceutical sector are crucial for the growth of the acetazolamide market. New formulations and expanded indications for acetazolamide can open up new opportunities and increase its market share[1].

Strategic Collaborations

Forming strategic collaborations with research institutions and healthcare providers can enhance the market reach and accelerate the development of acetazolamide-based therapies. This collaborative approach can lead to better market penetration and growth[1].

Market Segmentation

The acetazolamide market is segmented based on several criteria:

By Dosage Form

The market is segmented into injection, capsules, and tablets. Each form has its own set of applications and patient preferences, contributing to the overall market dynamics[1][3].

By Disease

Acetazolamide is used to treat various diseases, including glaucoma, epilepsy, heart failure, and others. The demand for the drug varies based on the prevalence and treatment needs of these conditions[1].

By Geography

The global acetazolamide market is classified into regions such as North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. North America and Europe are significant markets due to their advanced healthcare infrastructure and high awareness of medical conditions[1].

Challenges and Restraints

Despite the growth potential, the acetazolamide market faces several challenges:

Regulatory Compliance

The pharmaceutical industry is heavily regulated, and obtaining approvals for new formulations or indications can be a lengthy and complex process. Compliance with regulatory requirements poses challenges for manufacturers and can affect market dynamics[1].

Competition from Alternative Drugs

Acetazolamide faces competition from alternative medications and therapies, which can impact its market share. The availability of other treatment options for the same conditions can reduce the demand for acetazolamide[1].

Limitations in Clinical Trials

Studies on the use of acetazolamide, particularly in heart failure management, have shown promising results but also highlight limitations such as small sample sizes, lack of blinding, and limited external validity. These limitations necessitate further research to confirm the findings and optimize the role of acetazolamide in clinical practice[2].

Financial Performance and Key Players

The financial performance of the acetazolamide market is influenced by several key players:

Major Players

Companies such as Teva Pharmaceutical Industries Ltd., Mylan N.V., Sandoz International GmbH, Apotex Inc., Zydus Cadila, and others play a significant role in the market. These companies invest heavily in research and development and have a strong presence in various regions[1].

Recent Developments

Recent approvals, such as the US FDA's approval of Zydus Lifesciences Ltd's generic acetazolamide tablets, indicate the ongoing activity and innovation in the market. These developments contribute to the market's financial trajectory and growth prospects[1].

Extended Applications and Future Opportunities

Acetazolamide is being explored for extended applications beyond its traditional uses:

Chemotherapy Resistance

Research has shown that acetazolamide can help overcome resistance to chemotherapy drugs like temozolomide in the treatment of gliomas. This potential application offers lucrative growth opportunities for the drug in the near future[4].

Heart Failure Management

The use of acetazolamide as an adjunctive therapy in heart failure management has shown positive effects on decongestion and diuretic efficacy. Further research is needed to fully leverage this potential and integrate it into standard treatment protocols[2][5].

Market Attractiveness and Regional Analysis

The market attractiveness varies by region:

North America and Europe

These regions are traditionally significant markets for pharmaceuticals, including acetazolamide, due to their advanced healthcare infrastructure and high awareness of medical conditions[1].

Emerging Markets

Growing economies and increasing healthcare access in emerging markets offer untapped opportunities for acetazolamide manufacturers to expand their presence and cater to a broader patient base[1].

Key Takeaways

• The acetazolamide market is projected to grow significantly, reaching USD 499.69 billion by 2030.
• The market is driven by the increasing prevalence of medical conditions, advancements in medical research, and strategic collaborations.
• Challenges include regulatory compliance, competition from alternative drugs, and limitations in clinical trials.
• Key players are investing in research and development to expand the drug's indications and market reach.
• Extended applications, such as overcoming chemotherapy resistance and heart failure management, offer future growth opportunities.

FAQs

1. What is the current market size of the acetazolamide market? The acetazolamide market size was valued at USD 263.04 billion in 2022[1].

2. What is the projected growth rate of the acetazolamide market? The market is expected to grow at a CAGR of 4.60% from 2023 to 2030[1].

3. What are the primary drivers of the acetazolamide market? The primary drivers include the increasing prevalence of medical conditions, expansion of adventure and travel industries, and advancements in medical research[1].

4. Which regions are the most significant markets for acetazolamide? North America and Europe are traditionally significant markets due to their advanced healthcare infrastructure and high awareness of medical conditions[1].

5. What are some of the challenges faced by the acetazolamide market? Challenges include regulatory compliance, competition from alternative drugs, and limitations in clinical trials[1].

Cited Sources

1. Verified Market Research: Acetazolamide Market Size, Share, Trends, Analysis & Forecast.
2. MDPI: A Literature Review of an Adjunctive Approach in Heart Failure Management.
3. Market Research Intellect: Global Acetazolamide Drug Market Size, Scope And Forecast Report.
4. Coherent Market Insights: Acetazolamide Market Size and Trends.
5. American Heart Association: Decongestion With Acetazolamide in Acute Decompensated Heart Failure.