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Last Updated: December 23, 2024

ACETOHYDROXAMIC ACID - Generic Drug Details


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

Acetohydroxamic acid is the generic ingredient in one branded drug marketed by Mission Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for acetohydroxamic acid. One supplier is listed for this compound.

Summary for ACETOHYDROXAMIC ACID
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 143
Clinical Trials: 2
Patent Applications: 2,899
What excipients (inactive ingredients) are in ACETOHYDROXAMIC ACID?ACETOHYDROXAMIC ACID excipients list
DailyMed Link:ACETOHYDROXAMIC ACID at DailyMed
Recent Clinical Trials for ACETOHYDROXAMIC ACID

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

SponsorPhase
Data Management and Coordinating Center (DMCC)Phase 1/Phase 2
Children's Hospital of PhiladelphiaPhase 1/Phase 2
Nicholas Ah MewPhase 1/Phase 2

See all ACETOHYDROXAMIC ACID clinical trials

Pharmacology for ACETOHYDROXAMIC ACID
Drug ClassUrease Inhibitor
Mechanism of ActionUrease Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for ACETOHYDROXAMIC ACID

US Patents and Regulatory Information for ACETOHYDROXAMIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mission Pharma LITHOSTAT acetohydroxamic acid TABLET;ORAL 018749-001 May 31, 1983 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ACETOHYDROXAMIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetohydroxamic Acid

Overview of Acetohydroxamic Acid

Acetohydroxamic acid (AHA) is a synthetic drug derived from hydroxylamine and ethyl acetate, with a structure similar to urea. It is primarily used to treat urinary tract infections by preventing the growth of bacterial enzymes and reducing the production of ammonia in urine[1][5].

Market Size and Growth

The acetohydroxamic acid market is projected to experience significant growth over the forecast period of 2024-2030. The market size is expected to reach $661.55 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.30%[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Urinary Tract Infections

The rise in urinary tract infections, particularly among geriatric, diabetic, and infant populations, is a major driver for the acetohydroxamic acid market. The growing number of patients with these conditions increases the demand for effective treatments like AHA[1].

Geographic Expansion

The market is expected to see significant growth in regions such as Latin America, driven by the increasing number of diabetic patients. Brazil is identified as a major market for acetohydroxamic acid in this region[1].

Market Segmentation

By Purity

The market is segmented based on the purity of acetohydroxamic acid, which can vary depending on the manufacturing process and intended use. High-purity AHA is typically more expensive but is preferred for pharmaceutical applications due to its efficacy and safety profile[1].

By Form

Acetohydroxamic acid can be available in various forms, including powders, tablets, and solutions. The form of the drug can influence its absorption rate, patient compliance, and overall effectiveness[1].

By Packaging Type

The packaging of acetohydroxamic acid is crucial for maintaining its stability and shelf life. Different packaging types, such as blister packs, bottles, and sachets, cater to different patient needs and preferences[1].

By Application

The primary application of acetohydroxamic acid is in the treatment of urinary tract infections. However, it is also used in other medical conditions, such as in the management of urea-splitting bacteria in patients with urinary catheters or other urinary tract disorders[1].

Challenges and Constraints

Stringent Government Regulations

The acetohydroxamic acid market faces challenges from stringent government regulations. These regulations can impact the approval process, manufacturing standards, and distribution of the drug, potentially slowing market growth[1].

Side Effects and Safety Concerns

Acetohydroxamic acid can have side effects, which may deter some patients and healthcare providers from using it. Common side effects include gastrointestinal issues and allergic reactions, which can further hamper market growth[1].

Economic Instability and COVID-19 Impact

The unstable economic conditions and the COVID-19 pandemic have caused significant disruptions in the healthcare and pharmaceutical industries. These factors have affected the supply chain, production, and distribution of acetohydroxamic acid, leading to market volatility[1].

Financial Trajectory

Revenue Forecast

The revenue from the acetohydroxamic acid market is expected to increase steadily over the forecast period. By 2030, the market is projected to reach $661.55 million, indicating a robust financial trajectory driven by growing demand and expanding applications[1][4].

Regional Revenue Analysis

North America, Europe, and the Asia-Pacific region are significant contributors to the global acetohydroxamic acid market. The Latin American region, particularly Brazil, is expected to witness significant growth due to the increasing prevalence of diabetes and other related conditions[1].

Competitive Landscape

The market is characterized by a competitive landscape with several key players. Companies are focusing on improving the purity and form of acetohydroxamic acid to enhance its efficacy and patient compliance. The degree of competition is moderate, with opportunities for new entrants to innovate and capture market share[1].

Value Chain Analysis

Manufacturing

The manufacturing process of acetohydroxamic acid involves the synthesis of hydroxylamine and ethyl acetate. The purity and quality of the raw materials are critical in ensuring the efficacy of the final product[5].

Distribution

The distribution network for acetohydroxamic acid includes pharmaceutical distributors, hospitals, and retail pharmacies. Efficient distribution channels are essential for ensuring the drug reaches the end-users promptly and safely[1].

Pricing Analysis

The pricing of acetohydroxamic acid is influenced by factors such as production costs, regulatory approvals, and market demand. High-purity forms of the drug tend to be more expensive, while generic versions may offer more affordable alternatives[1].

Opportunities and Threats

Opportunities

  • Growing Demand: The increasing prevalence of urinary tract infections and other related conditions presents a significant opportunity for market growth.
  • Innovative Formulations: Developing new formulations and delivery systems can enhance patient compliance and efficacy, opening up new market opportunities.
  • Emerging Markets: Expanding into emerging markets, particularly in Latin America and the Asia-Pacific region, can provide substantial growth opportunities[1].

Threats

  • Regulatory Challenges: Stringent government regulations can pose significant challenges to market growth.
  • Side Effects: The potential side effects of acetohydroxamic acid can deter patients and healthcare providers, impacting market demand.
  • Economic Volatility: Economic instability and global health crises like the COVID-19 pandemic can disrupt the supply chain and market dynamics[1].

Key Takeaways

  • The acetohydroxamic acid market is expected to reach $661.55 million by 2030, growing at a CAGR of 5.30%.
  • The Latin American region, particularly Brazil, is projected to witness significant growth.
  • Stringent government regulations and side effects are major constraints to market growth.
  • Innovative formulations and expanding into emerging markets offer significant opportunities for growth.

FAQs

What is the primary use of acetohydroxamic acid?

Acetohydroxamic acid is primarily used to treat urinary tract infections by preventing the growth of bacterial enzymes and reducing the production of ammonia in urine.

What are the key drivers of the acetohydroxamic acid market?

The key drivers include the increasing prevalence of urinary tract infections, particularly among geriatric, diabetic, and infant populations, and geographic expansion into regions like Latin America.

What are the major challenges facing the acetohydroxamic acid market?

The major challenges include stringent government regulations, potential side effects, and economic instability due to global health crises like the COVID-19 pandemic.

Which region is expected to witness significant growth in the acetohydroxamic acid market?

The Latin American region, particularly Brazil, is expected to witness significant growth due to the increasing number of diabetic patients.

What is the projected market size of acetohydroxamic acid by 2030?

The market is projected to reach $661.55 million by 2030, growing at a CAGR of 5.30%.

Sources

  1. IndustryARC: Acetohydroxamic Acid Market Size Report, 2024-2030.
  2. Journal of Radioanalytical and Nuclear Chemistry: New data on decomposition of nitric solutions of acetohydroxamic acid.
  3. Journal of Medicinal Chemistry: Natural Products as Sources of New Drugs over the Nearly Four Decades.
  4. Market Research Reports: Global Acetohydroxamic Acid Market Growth 2024-2030.
  5. Ambeed.com: Acetohydroxamic acid - CAS No. 546-88-3.

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