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Last Updated: December 22, 2024

Metronidazole hydrochloride - Generic Drug Details


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

Metronidazole hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer and Abraxis Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for metronidazole hydrochloride
Recent Clinical Trials for metronidazole hydrochloride

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

SponsorPhase
Hospital Universitario Evangelico de CuritibaPhase 3
National Institute of Dental and Craniofacial Research (NIDCR)Phase 3
National Dental PBRNPhase 3

See all metronidazole hydrochloride clinical trials

US Patents and Regulatory Information for metronidazole hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer FLAGYL I.V. metronidazole hydrochloride INJECTABLE;INJECTION 018353-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abraxis Pharm METRONIDAZOLE HYDROCHLORIDE metronidazole hydrochloride INJECTABLE;INJECTION 070295-001 Oct 15, 1985 DISCN No No ⤷  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

Metronidazole hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metronidazole Hydrochloride

Market Size and Forecast

The metronidazole market is poised for significant growth in the coming years. As of 2023, the market size was valued at approximately USD 101 million, and it is projected to reach USD 139.97 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.1% from 2024 to 2031[1][3].

Key Drivers of Market Growth

Increasing Incidence of Bacterial Infections

The rising prevalence of bacterial infections, particularly those caused by anaerobic bacteria, is a major driver for the demand of metronidazole. Its effectiveness as an antibacterial and antiprotozoal agent makes it a crucial treatment option for these infections[1].

Growth in Gastrointestinal Disorders

Conditions such as inflammatory bowel disease (IBD), Clostridium difficile infections, and other gastrointestinal tract infections contribute to the increased use of metronidazole, thereby expanding the market[1].

Rising Awareness and Diagnosis

Improved awareness and advancements in diagnostic techniques lead to the early detection of infections treatable by metronidazole, resulting in higher prescription rates[1].

Development of Combination Therapies

Metronidazole is often used in combination with other antibiotics to enhance treatment efficacy. The trend towards combination therapies is expected to drive its demand further[1].

Emerging Market Opportunities

Expansion in emerging economies, where healthcare access is improving and the penetration of antibiotics is increasing, presents significant growth opportunities for the metronidazole market[1].

Regulatory Approvals and Innovations

New formulations, routes of administration, and methods of delivery (such as extended-release formulations) being developed and approved can stimulate market growth. Innovations in packaging and delivery systems can also enhance market prospects[1].

Aging Population

An aging demographic is more susceptible to infections, which can drive the demand for antibiotics like metronidazole[1].

Increased Veterinary Applications

The use of metronidazole in veterinary medicine for treating infections in animals, including dogs, cats, and horses, adds to the market demand[4].

Market Penetration of Generic Drugs

The availability of generic versions of metronidazole can lower costs and increase access, leading to higher utilization. Generic drugs are considered just as safe and effective as brand-name medications but tend to be more affordable[2].

Geographical Segmentation

The metronidazole market is segmented geographically into several key regions:

North America

Characterized by advanced healthcare infrastructure, robust pharmaceutical development, and a high prevalence of infections like bacterial vaginosis and gastroenteritis, North America is a pivotal market for metronidazole[1].

Europe

Europe follows closely, with stringent regulations and a well-established healthcare system driving the market. Rising awareness about infectious diseases and the adoption of metronidazole in surgical prophylaxis and other therapeutic applications also contribute to its growth[1].

Asia-Pacific

The Asia-Pacific region is witnessing rapid growth due to increasing healthcare access, rising disposable incomes, and a surge in infectious disease prevalence, particularly in emerging economies like India and China[1].

Middle East and Africa

The market in this region is influenced by the growing pharmaceutical sector and increasing public health initiatives to combat infectious diseases, although challenges such as regulatory constraints and limited access to healthcare persist[1].

Latin America

Latin America is experiencing gradual market growth, propelled by improving healthcare services and the rising incidence of gastrointestinal infections, though it still faces challenges related to drug accessibility and affordability[1].

Distribution Channels

The distribution of metronidazole is segmented across various channels:

Hospital Pharmacy

Metronidazole is widely used in hospital settings for treating a range of infections, making hospital pharmacies a significant distribution channel[4].

Retail Pharmacy

Retail pharmacies also play a crucial role in the distribution of metronidazole, especially for outpatient treatments[4].

Online Retail

The rise of online retail has made it easier for patients to access metronidazole, contributing to its market growth[4].

Challenges and Restraints

Despite the positive growth trajectory, the metronidazole market faces several challenges:

Emergence of Alternative Therapies

The development of new antibiotics or antimicrobial agents that are more effective or have fewer side effects could lead healthcare providers to prefer these alternatives over metronidazole[1].

Public Health Issues

Increasing awareness of antibiotic stewardship and the appropriate use of antibiotics can limit the prescriptions of metronidazole, especially in settings where its use may be considered inappropriate[1].

Supply Chain Disruptions

Issues such as raw material shortages, manufacturing delays, or logistics challenges can impact the availability of metronidazole in the market, affecting sales[1].

Economic Factors

Economic downturns or shifts in healthcare funding may impact drug pricing and accessibility, limiting patient access to metronidazole and thereby restraining market growth[1].

Financial Implications

Cost Variability

The cost of metronidazole can vary based on the treatment plan, insurance coverage, and the pharmacy used. For instance, the strength of the medication and the type of formulation (e.g., tablets, capsules, gels, creams) can influence pricing[2].

Hospitalization and Treatment Costs

Infections treated with metronidazole can significantly increase hospitalization costs. For example, a study showed that the presence of any infection increased the mean hospital stay from 8.7 days to 23.3 days and increased hospital charges from $24,507 to $104,920[5].

Key Takeaways

  • The metronidazole market is expected to grow significantly, driven by increasing bacterial infections, gastrointestinal disorders, and emerging market opportunities.
  • Geographical segmentation highlights North America, Europe, and the Asia-Pacific region as key markets.
  • Distribution channels include hospital pharmacies, retail pharmacies, and online retail.
  • Challenges such as alternative therapies, public health issues, supply chain disruptions, and economic factors could restrain market growth.
  • The cost of metronidazole varies based on several factors, and its use can impact hospitalization and treatment costs.

FAQs

1. What is the projected market size of metronidazole by 2031? The metronidazole market is projected to reach USD 139.97 million by 2031, growing at a CAGR of 5.1% from 2024 to 2031[1].

2. What are the main drivers of the metronidazole market growth? Key drivers include the increasing incidence of bacterial infections, growth in gastrointestinal disorders, rising awareness and diagnosis, development of combination therapies, and emerging market opportunities[1].

3. How does the cost of metronidazole vary? The cost of metronidazole can vary based on the treatment plan, insurance coverage, and the pharmacy used. The strength of the medication and the type of formulation also influence pricing[2].

4. What are the primary distribution channels for metronidazole? The primary distribution channels include hospital pharmacies, retail pharmacies, and online retail[4].

5. What challenges might restrain the growth of the metronidazole market? Challenges include the emergence of alternative therapies, public health issues related to antibiotic stewardship, supply chain disruptions, and economic factors affecting drug pricing and accessibility[1].

Cited Sources:

  1. Verified Market Research - Metronidazole Market Size, Share, Scope, Trends & Forecast
  2. Healthline - Metronidazole Cost, Coupons, Financial Assistance, and More
  3. Market Research Intellect - Metronidazole Market Size, Trends and Projections
  4. IndustryARC - Metronidazole Market - Forecast(2017-2025) Research Report
  5. JAMA Network - A Trial of Ciprofloxacin and Metronidazole vs Gentamicin and Metronidazole

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