You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

METRONIDAZOLE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Metronidazole patents expire, and when can generic versions of Metronidazole launch?

Metronidazole is a drug marketed by Able, Alembic, Chartwell Rx, Cosette, Fougera Pharms, Zydus Lifesciences, Aurobindo Pharma Ltd, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Alembic Pharms Ltd, Appco, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Esjay Pharma, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, and Rising. and is included in sixty-nine NDAs.

The generic ingredient in METRONIDAZOLE is metronidazole hydrochloride. There are eighteen drug master file entries for this compound. Additional details are available on the metronidazole hydrochloride profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for METRONIDAZOLE?
  • What are the global sales for METRONIDAZOLE?
  • What is Average Wholesale Price for METRONIDAZOLE?
Drug patent expirations by year for METRONIDAZOLE
Drug Prices for METRONIDAZOLE

See drug prices for METRONIDAZOLE

Drug Sales Revenue Trends for METRONIDAZOLE

See drug sales revenues for METRONIDAZOLE

Paragraph IV (Patent) Challenges for METRONIDAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUVESSA Vaginal Gel metronidazole 1.30% 205223 1 2022-03-30
METROGEL Topical Gel metronidazole 1% 021789 1 2008-10-21
METROGEL-VAGINAL Vaginal Gel metronidazole 0.75% 020208 1 2004-09-02

US Patents and Regulatory Information for METRONIDAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Superpharm METRONIDAZOLE metronidazole TABLET;ORAL 070009-001 Dec 11, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd METRONIDAZOLE metronidazole TABLET;ORAL 203974-002 May 29, 2015 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Able METRONIDAZOLE metronidazole TABLET;ORAL 076519-001 Jun 27, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira METRONIDAZOLE IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 018890-002 Nov 18, 1983 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Esjay Pharma METRONIDAZOLE metronidazole TABLET;ORAL 208162-002 May 25, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Innogenix METRONIDAZOLE metronidazole TABLET;ORAL 070772-002 Jul 16, 1986 AB RX 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metronidazole

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 100-101 million[1][3][5].

  • By 2031, the market is projected to reach USD 139.97-139.99 million, growing at a Compound Annual Growth Rate (CAGR) of 5-5.1% from 2024 to 2031[1][3].

Driving Factors

Several key factors are driving the growth of the metronidazole market:

Increasing Incidence of Bacterial Infections

The rising prevalence of bacterial infections, particularly those caused by anaerobic bacteria, is a significant driver. Metronidazole's effectiveness as an antibacterial and antiprotozoal agent makes it a preferred treatment option[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 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. This 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. For instance, innovative formulations can improve patient compliance and treatment outcomes[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 also contributes to market growth[1].

Market Penetration of Generic Drugs

The availability of generic versions of metronidazole can lower costs and increase access, leading to higher utilization rates[1].

Geographical Segmentation

The metronidazole market is segmented geographically into several key regions:

North America

Characterized by advanced healthcare infrastructure 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. There is also rising awareness about infectious diseases and the adoption of metronidazole in surgical prophylaxis and other therapeutic applications[1].

Asia-Pacific

This 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].

Challenges and Restraints

Despite the growth potential, 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].

Market Dynamics and Negotiations

The market dynamics are also influenced by various negotiations and strategies:

Pharmacy Benefit Managers (PBMs) and Cost-Containment Strategies

The rise of PBMs and cost-containment strategies by healthcare insurers can affect pricing and reimbursement for metronidazole, creating additional hurdles for manufacturers[1].

Financial Trajectory

The financial trajectory of the metronidazole market is positive, driven by the factors mentioned above.

  • Revenue Growth: The market is expected to grow from USD 100-101 million in 2023 to USD 139.97-139.99 million by 2031, indicating a steady increase in revenue[1][3].

  • CAGR: The CAGR of 5-5.1% from 2024 to 2031 highlights the consistent growth rate of the market[1][3].

  • Long-Term Projections: Some reports project the market to reach as high as USD 168.41 billion by 2032, although this figure is significantly higher and may reflect broader market segments or different forecasting models[5].

Key Players

The metronidazole market is dominated by several key players:

  • Hongyuan Pharmaceutical
  • Yinhe Aarti Pharmaceutical
  • Saikang Pharmaceutical
  • Zhongan Pharmaceutical
  • Wuyao Pharmaceutical

These companies are instrumental in driving the market through their production and distribution capabilities, as well as their involvement in research and development[5].

Illustrative Statistics

  • Market Size: USD 100-101 million in 2023, projected to reach USD 139.97-139.99 million by 2031[1][3].
  • CAGR: 5-5.1% from 2024 to 2031[1][3].
  • Geographical Growth: Asia-Pacific region is witnessing rapid growth due to increasing healthcare access and rising disposable incomes[1].

Quotes from Industry Experts

"Metronidazole is a versatile antibiotic and antiprotozoal drug that is quite efficient against certain parasites and anaerobic bacteria. Its wide range of action and low cost make it a mainstay treatment for various bacterial and protozoal illnesses," - Industry Expert[3].

Highlight and Citation

"Because metronidazole is widely used to treat a variety of bacterial and protozoal illnesses, the market for the drug is steadily expanding. The versatile antibiotic and antiprotozoal drug metronidazole is quite efficient against certain parasites and anaerobic bacteria." - Market Research Intellect[3]

Key Takeaways

  • The metronidazole market is expected to grow significantly, driven by increasing bacterial infections, gastrointestinal disorders, and emerging market opportunities.
  • The market is segmented geographically, with North America, Europe, and Asia-Pacific being key regions.
  • Challenges include the emergence of alternative therapies, public health issues, supply chain disruptions, and economic factors.
  • Key players such as Hongyuan Pharmaceutical and Yinhe Aarti Pharmaceutical are driving the market through production and distribution.
  • The market is projected to reach USD 139.97-139.99 million by 2031, growing at a CAGR of 5-5.1%.

Frequently Asked Questions

1. What is the projected market size of metronidazole by 2031? The metronidazole market is projected to reach USD 139.97-139.99 million by 2031[1][3].

2. What is the CAGR of the metronidazole market from 2024 to 2031? The CAGR of the metronidazole market is expected to be 5-5.1% from 2024 to 2031[1][3].

3. What are the primary drivers of the metronidazole market? The primary drivers include the increasing incidence of bacterial infections, growth in gastrointestinal disorders, rising awareness and diagnosis, and the development of combination therapies[1].

4. Which regions are expected to see significant growth in the metronidazole market? The Asia-Pacific region is expected to witness rapid growth due to increasing healthcare access and rising disposable incomes. North America and Europe are also key markets[1].

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].

Sources Cited

  1. Verified Market Research - Metronidazole Market Size, Share, Scope, Trends & Forecast
  2. IQVIA - Transitional Assistance Programs in the GLP-1 Market
  3. Market Research Intellect - Global Metronidazole Market Size, Trends and Projections
  4. Market Research Intellect - Metronidazole Consumption Market Size and Forecast
  5. Business Research Insights - Metronidazole Market Report | Global Forecast To 2032

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.