Metronidazole - Generic Drug Details

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

Metronidazole is the generic ingredient in twenty branded drugs marketed by Pfizer, Able, Alembic, Chartwell Rx, Galderma Labs Lp, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Aurobindo Pharma Ltd, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Solaris Pharma Corp, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Amneal, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Rising, Saptalis Pharms, Labs Af, 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, Ortho Mcneil Pharm, and Savage Labs, and is included in eighty-nine NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has twenty-one patent family members in nine countries.

There are eighteen drug master file entries for metronidazole. Seventy-three suppliers are listed for this compound.

Summary for metronidazole

International Patents:	21
US Patents:	9
Tradenames:	20
Applicants:	54
NDAs:	89
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	73
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	526
Patent Applications:	7,347
Drug Prices:	Drug price trends for metronidazole
Drug Sales Revenues:	Drug sales revenues for metronidazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metronidazole
What excipients (inactive ingredients) are in metronidazole?	metronidazole excipients list
DailyMed Link:	metronidazole at DailyMed

See drug prices for metronidazole

See drug sales revenues for metronidazole

Recent Clinical Trials for metronidazole

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

Sponsor	Phase
Hospital Universitario Evangelico de Curitiba	Phase 3
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3
National Dental PBRN	Phase 3

See all metronidazole clinical trials

Pharmacology for metronidazole

Drug Class

Nitroimidazole Antimicrobial

Medical Subject Heading (MeSH) Categories for metronidazole

Anti-Infective Agents

Antiprotozoal Agents

Radiation-Sensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for metronidazole

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

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
Cosette	METRONIDAZOLE	metronidazole	GEL;TOPICAL	078178-001	Jan 19, 2011	AB	RX	No	Yes
Superpharm	METRONIDAZOLE	metronidazole	TABLET;ORAL	070008-001	Dec 11, 1984		DISCN	No	No
Innogenix	METRONIDAZOLE	metronidazole	TABLET;ORAL	070772-002	Jul 16, 1986	AB	RX	No	No
Aurobindo Pharma Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	203974-001	May 29, 2015	AB	RX	No	No
Alembic	METRONIDAZOLE	metronidazole	TABLET;ORAL	208681-001	Jun 20, 2017	AB	RX	No	No
Strides Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	070040-001	Jan 29, 1985	AB	RX	No	No

Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005

International Patents for metronidazole

Country	Patent Number	Title	Estimated Expiration
Japan	2014518272
European Patent Office	2725904	FORMULATIONS DE GEL À BASE DE MÉTRONIDAZOLE AQUEUX MUCOADHÉSIF À DOSAGE ÉLEVÉ ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTÉRIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS)
Canada	3087789	FORMULATIONS ORALES DE METRONIDAZOLE ET METHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL A CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)
Japan	6235087
Mexico	2020007494	FORMULACIONES ORALES DE METRONIDAZOL Y METODOS DE TRATAMIENTO DE UNA INFECCION CON LAS MISMAS. (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME.)
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana

Supplementary Protection Certificates for metronidazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209

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