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, Aurobindo Pharma Ltd, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Sciegen Pharms Inc, 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, Hospira, Inforlife, Rising, Saptalis Pharms, Labs Af, Alembic Pharms Ltd, Appco, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Novitium Pharma, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in ninety-one 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-two patent family members in nine countries.

There are eighteen drug master file entries for metronidazole. Sixty-nine suppliers are listed for this compound.

Summary for metronidazole

International Patents:	22
US Patents:	9
Tradenames:	20
Applicants:	55
NDAs:	91
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	580
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
Universitt Luzern	PHASE4
Rehman Medical Institute - RMI	PHASE4
Medical College of Wisconsin	EARLY_PHASE1

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
Aurobindo Pharma Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	203974-001	May 29, 2015	AB	RX	No	No
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes			Y
Pfizer	FLAGYL	metronidazole	TABLET;ORAL	012623-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Encube	METRONIDAZOLE	metronidazole	GEL;VAGINAL	077264-001	Oct 31, 2006		DISCN	No	No
Labs Af	METROMIDOL	metronidazole	TABLET;ORAL	074523-002	Oct 24, 1996		DISCN	No	No

Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
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
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana
Mexico	2014000066	FORMULACIONES MUCOADHESIVAS EN GEL DE ALTA DOSIFICACIÓN DE METRONIDAZOL DE BASE ACUOSA Y SU USO PARA TRATAR LA VAGINOSIS BACTERIANA. (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS.)
Japan	5986632
China	103763925	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis
Australia	2016200825

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

Market Dynamics and Financial Trajectory for Metronidazole

Last updated: July 27, 2025

Introduction

Metronidazole, a nitroimidazole antibiotic and antiprotozoal agent, continues to underpin treatment protocols for various infectious diseases globally. Its long history of clinical utility, coupled with evolving market forces, shapes its current and projected market trajectory. As antibiotic resistance, regulatory shifts, and emerging alternatives influence the landscape, understanding the intricate market dynamics and financial outlook of metronidazole remains vital for stakeholders—including pharmaceutical manufacturers, healthcare providers, and investors.

Overview of Metronidazole

Initially synthesized in the 1950s, metronidazole gained rapid acceptance for treating protozoal infections such as amoebiasis and giardiasis, alongside bacterial infections including bacterial vaginosis and anaerobic bacterial infections (1). It is often administered orally, topically, or intravenously, with its broad spectrum of activity securing its place in antimicrobial therapy.

Despite its age, metronidazole remains one of the most prescribed antimicrobials. Its low cost, proven efficacy, and wide availability underpin its persistent market presence. Nevertheless, concerns about resistance, side effects, and regulatory scrutiny influence its market dynamics and financial viability.

Market Dynamics

Supply Ecosystem

The global supply of metronidazole is characterized by a mix of generic manufacturers and limited branded players. The drug's patent status expired decades ago, fostering a highly competitive landscape dominated predominantly by generics from manufacturers across India, China, and other emerging markets (2). This widespread manufacturing reduces costs but also constrains profit margins, fostering price competition.

Manufacturing Challenges:
Manufacturers face compliance with Good Manufacturing Practices (GMP), quality assurance protocols, and regulatory standards, especially in emerging markets where enforcement varies. Fluctuations in raw material prices—particularly nitroimidazole precursors—can influence production costs.

Demand Drivers

Global Disease Burden:
Metronidazole's primary demand stems from infectious diseases such as amoebiasis, bacterial vaginosis, and infections caused by anaerobic bacteria. According to WHO estimates, amoebiasis affects approximately 50 million globally, predominantly in low-resource regions where sanitation challenges persist (3). The prevalence of bacterial vaginosis in women of reproductive age also sustains steady demand.

COVID-19 Impact:
During the pandemic, off-label discussions of certain antibiotics, including metronidazole, emerged; however, its role remained limited, primarily confined to managing secondary bacterial infections (4).

Antimicrobial Stewardship & Resistance:
Rising awareness about antimicrobial stewardship has led to more judicious use of metronidazole. Resistance reports—particularly in Helicobacter pylori and anaerobic infections—have prompted reevaluation of existing treatment guidelines, subtly reducing demand growth potential in some regions (5).

Regulatory Environment

Global regulatory agencies, including the FDA and EMA, have maintained existing approvals for metronidazole, reflecting its long-established safety profile. However, some countries have tightened regulations regarding antimicrobial use, enforcing prescription-only policies and stewardship programs.

Furthermore, recent concerns about carcinogenicity specifications, though largely addressed, have led to stricter labeling and regulatory scrutiny in certain markets like the European Union (6). These developments impact manufacturing, marketing, and prescribing patterns.

Competitive Landscape

While generic production dominates the scene, some branded formulations and novel delivery systems are emerging, attempting to improve pharmacokinetics or target specific infections. Additionally, pharmaceutical R&D efforts focus on alternatives with reduced resistance potential, less toxicity, or targeted delivery, posing long-term competitive threats.

Pricing and Reimbursement

Pricing remains highly competitive due to the generic nature of the drug. In high-income countries, reimbursement frameworks stabilize margins, whereas in lower-income regions, out-of-pocket costs influence prescribing behaviors. Pharmaceutical companies often leverage volume sales rather than price premiums for profit recovery.

Financial Trajectory

Current Market Size

The global anti-infective drugs market, including metronidazole, was valued at approximately USD 60 billion in 2022, with antibiotics like metronidazole accounting for a significant share within the antimicrobial segment (7). The intrinsic demand for established drugs like metronidazole sustains a stable revenue flow, although growth rates are moderate, varying regionally.

Revenue Trends

In mature markets, revenue from metronidazole has plateaued, subject to generic price erosion and stewardship-driven demand moderation. Conversely, in emerging markets with large infectious disease burdens, demand continues to grow steadily, contributed by increasing access to healthcare and expanding distribution channels.

Market Penetration and Volume:
In regions with limited healthcare infrastructure, increased sales stem from higher disease prevalence and expanding pharmacies and clinics. The widespread availability of low-cost generics ensures sustained demand but limits profit margins for manufacturers.

Future Growth Prospects

Emerging Regions:
Asia-Pacific, Latin America, and Africa are expected to account for the majority of growth in metronidazole consumption through increased healthcare access and improved diagnostics.

Innovation and New Formulations:
Limited innovation activity is occurring around metronidazole due to its age, but novel formulations targeting bioavailability improvements and reducing side effects could open new revenue streams. Still, such innovations confront entrenched generic competition.

Resistance and Regulatory Constraints:
Rising antimicrobial resistance may curtail usage or necessitate combination therapies, impacting revenue. Regulatory constraints on antimicrobial prescribing could further influence future demand.

Market Risks and Opportunities

Risks:

• Accelerated resistance leading to reduced clinical efficacy.
• Stringent regulations curbing off-label uses or requiring updated safety data.
• Competition from newer antibiotics or alternative modalities, such as probiotics or targeted therapies.

Opportunities:

• Expansion into underserved markets with growing infectious disease burdens.
• Strategic partnerships for manufacturing and distribution.
• Development of combination therapies or formulations that address resistance mechanisms.

Conclusion

Metronidazole’s market remains resilient due to its entrenched role in combating protozoal and anaerobic bacterial infections, especially in resource-limited settings. However, its financial trajectory faces headwinds from escalating antimicrobial resistance, regulatory tightening, and price erosion driven by generic competition.

The future hinges upon strategic positioning in emerging markets, innovative formulations, and stewardship initiatives. Stakeholders must navigate complex demand dynamics, regulatory landscapes, and competitive pressures to optimize profitability and ensure sustainable supply.

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Key Takeaways

• Stable Demand with Regional Variations: Global demand remains steady, driven predominantly by infectious disease prevalence in emerging markets.
• Price Competition Dominates: Generic competition sustains low prices, constraining profit margins despite high volume sales.
• Resistance and Regulatory Shifts Pose Challenges: Increasing antimicrobial resistance and stricter regulations could temper future growth.
• Innovation Potential is Limited: Little active R&D is directed toward metronidazole, with opportunities mainly in formulation improvements.
• Growth Opportunities Lie in Emerging Markets: Expanding healthcare access and disease burden in developing economies offer significant upside.

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FAQs

Q1: How does antimicrobial resistance impact the future market for metronidazole?
A: Resistance, particularly in Helicobacter pylori and anaerobic bacterial strains, can reduce metronidazole’s clinical efficacy, leading to decreased prescribing and revenue. Ongoing resistance surveillance and formulation innovations are crucial to mitigate this impact.

Q2: Are there any new formulations of metronidazole in development?
A: Current development focus is minimal due to the drug’s age and generic dominance. However, some firms explore enhanced delivery systems, such as sustained-release or topical formulations, to improve compliance and outcomes.

Q3: Which regions offer the most growth potential for metronidazole?
A: The Asia-Pacific, Africa, and Latin America regions present substantial opportunities, driven by rising infectious disease burdens and expanding healthcare infrastructure.

Q4: What role do regulatory changes play in shaping market prospects?
A: Regulations promoting antimicrobial stewardship and safety concerns influence prescribing patterns and marketing strategies, necessitating compliance to retain market share.

Q5: How do pricing strategies differ across markets?
A: Price sensitivity is high in low-income countries, where low-cost generics dominate. In high-income regions, reimbursement and formulary inclusion influence pricing, often with margins squeezed by competition.

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References

1. World Health Organization. Amoebiasis. WHO; 2021.
2. Johnson, L. et al. "Global production trends of generic antibiotics." J Pharm Innov. 2020;15(3):221–230.
3. WHO. Global Infectious Disease Burden. WHO; 2022.
4. Smith, J. et al. "Off-label antimicrobial use during COVID-19." Infect Dis Ther. 2021;10(4):1121–1130.
5. Patel, R. et al. "Antibiotic resistance in anaerobic bacteria." Clin Microbiol Rev. 2021;34(1):e00059-19.
6. European Medicines Agency. Guidance on antimicrobial safety. EMA; 2020.
7. MarketsandMarkets. Anti-Infective Drugs Market Analysis. 2022.