METRONIDAZOLE - Generic Drug Details

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

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-seven 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:	67
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	587
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
Faiz ur rahman	NA
Stanford University	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
LIKMEZ	Oral Suspension	metronidazole	500 mg/5 mL	216755	1	2025-11-13
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
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	018599-001	Sep 17, 1982		DISCN	No	No
Encube	METRONIDAZOLE	metronidazole	GEL;TOPICAL	077547-001	Jul 13, 2006	AB	RX	No	No
Cadila	METRONIDAZOLE	metronidazole	TABLET;ORAL	206560-002	Nov 16, 2016	AB	RX	No	No
Chartwell Molecules	METRONIDAZOLE	metronidazole	TABLET;ORAL	018930-001	Aug 18, 1983		DISCN	No	No
Innogenix	METRONIDAZOLE	metronidazole	TABLET;ORAL	070772-002	Jul 16, 1986	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
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997
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	5986632
Japan	2017014248	高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 (HIGH-DOSE MUCOADHESIVE METRONIDAZOLE AQUEOUS GEL PREPARATION, AND USE OF THE SAME FOR TREATING BACTERIAL VAGINOSIS)
Mexico	381271	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)
European Patent Office	2725904
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)

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: January 11, 2026

Executive Summary

Metronidazole, a nitroimidazole antimicrobial agent, has been a mainstay in treating parasitic infections, bacterial vaginosis, and anaerobic bacterial infections for decades. Its established efficacy, broad-spectrum activity, and affordability position it prominently within the antimicrobial market. As antimicrobial resistance and the global burden of infectious diseases evolve, understanding the market dynamics and financial trajectory of metronidazole provides strategic insights for stakeholders.

This report evaluates key market drivers, challenges, regulatory influences, and competitive landscape shaping the future of metronidazole. It analyses current sales figures, pricing strategies, geographic markets, and emerging trends, offering an authoritative guide for pharmaceutical firms, investors, and healthcare policymakers.

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1. Overview of Metronidazole

1.1 Chemical and Therapeutic Profile

Parameter	Details
Chemical Class	Nitroimidazole
Common Brand Names	Flagyl, Metrogel, Noritate, Certol
Approved Indications	Bacterial vaginosis, Trichomoniasis, Amoebiasis, Anaerobic infections
Mode of Action	Disrupts DNA synthesis in anaerobic bacteria and protozoa

1.2 Market Penetration History

Discovered in the 1960s, metronidazole became widely available and remains on essential medicines lists globally [1]. Its low manufacturing cost and high efficacy have cemented its role in infectious disease management.

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2. Market Size and Revenue Analysis

2.1 Global Sales Estimates

Year	Estimated Global Revenue	Notes
2018	~$500 million	Considered mature, stable market
2020	~$550 million	Slight growth, increased use in low-income regions
2022	~$600 million	Continuing steady growth, sporadic regional fluctuations

Sources: IQVIA reports, Global Data analytics (cited as [2])

2.2 Geographic Market Breakdown

Region	Market Share	Key Drivers
North America	40%	Established healthcare infrastructure, generic use
Europe	25%	Regulatory approvals, antibiotic stewardship programs
Asia-Pacific	20%	Growing infectious disease burden, price-sensitive markets
Latin America	10%	Increasing use in parasitic infections
Africa	5%	Emerging markets, lack of alternatives

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3. Market Drivers

3.1 Rising Incidence of Parasitic and Anaerobic Infections

The World Health Organization (WHO) reports that parasitic infections affect over 1 billion people globally, sustaining consistent demand [3]. The increase in anaerobic bacterial infections in hospital settings maintains metronidazole’s vital role.

3.2 Cost-Effectiveness and Generic Availability

Metronidazole's inclusion in WHO's Essential Medicines List (WHO, 2019) underscores its affordability. Widespread generic production reduces costs, enabling extensive use especially in low-resource settings.

3.3 Expanding Use in Combination Therapies

Emerging evidence suggests metronidazole as an adjunct in Helicobacter pylori eradication protocols and in periodontal disease management, broadening its application scope [4].

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4. Market Challenges

4.1 Antimicrobial Resistance

Increasing resistance among Trichomonas vaginalis and Helicobacter pylori strains threatens efficacy, leading to potential reformulations or alternative therapies. WHO categorizes antimicrobial resistance as a critical global health issue [5].

4.2 Regulatory and Patent Dynamics

While many formulations are off-patent, some branded versions benefit from regulatory exclusivities, impacting pricing strategies.

4.3 Safety and Side Effect Profiles

Adverse effects such as neurotoxicity and contraindications in pregnant women constrain usage in specific populations, influencing prescribing habits.

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5. Competitive Landscape

Player	Market Share	Key Focus Areas	Notable Products
Teva Pharmaceuticals	~40%	Generic manufacturing, global distribution	Flagyl (generic)
Mylan/NuGeneration	~25%	Affordable generics, regional markets	Metronidazole tablets
Sun Pharma	~15%	Latin America, India market	Metrogel, Flagyl
Local/National Makers	Remaining	Price-sensitive markets, formulations with niche indications	Various local brands

5.1 Patent and Regulatory Influence

While most formulations are off-patent, some patented combination formulations and extended-release versions aim to extend market exclusivity [6].

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6. Emerging Trends and Future Trajectory

6.1 Nanotechnology and Delivery Innovations

Research into nanoparticle-based delivery aims to improve bioavailability and reduce side effects, which could influence market dynamics [7].

6.2 Resistance Monitoring and Stewardship

Global efforts to monitor resistance patterns lead to guideline updates, potentially influencing demand. For example, the CDC recommends reserved use for specific indications [8].

6.3 Digital and Telemedicine Integration

Increased telehealth services expand prescriptions, especially in rural and underserved areas, potentially increasing volumetric sales.

6.4 Potential for Novel Formulations

Investments in sustained-release formulations and topical applications open new avenues for market growth.

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7. Regulatory and Policy Environment

Policy/Regulation	Impact	Source
WHO Essential Medicines List 2019	Endorses widespread use, supports generic manufacturing	[1]
US FDA Guidance on Antibiotics	Emphasizes antimicrobial stewardship, may limit overprescription	[9]
European Medicines Agency (EMA) approvals	Approvals of topical and combination formulations	[10]
Global AMR Action Plan (WHO, 2015)	Pushes for prudent use, resistance monitoring	[3]

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8. Comparative Analysis: Metronidazole vs. Alternatives

Parameter	Metronidazole	Alternative Agents	Remarks
Spectrum	Broad activity against anaerobes, protozoa	Tinidazole, Ornidazole	Slightly improved tolerability or pharmacokinetics in some
Cost	Low	Higher (e.g., tinidazole)	Cost-effective, especially in resource-limited settings
Resistance	Increasing in some pathogens	Resistance also emerging in alternatives	Necessitates stewardship and combination strategies
Safety	Neurotoxicity, contraindicated in pregnancy	Similar profile, varies with formulation	Shift to combination formulations or topical use possible

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9. Financial Trajectory and Investment Outlook

9.1 Revenue Forecasts (2023-2028)

Year	Projected Revenue	Growth Rate	Comments
2023	~$610 million	+1.5%	Steady market with regional upticks in developing areas
2024	~$620 million	+1.6%	Growth driven by emerging markets
2025	~$630 million	+1.6%	Resistance management initiatives underway
2026	~$640 million	+1.6%	Potential new formulations introduce marginal shifts
2027	~$650 million	+1.5%	Market stabilizes, generics continue dominance
2028	~$660 million	+1.5%	Market reaches maturity, growth driven by global health events

Assumptions: Growth influenced by regional demand, resistance trends, and generics’ pricing strategies.

9.2 Investment Opportunities

• Development of resistance testing platforms to optimize usage.
• Formulation innovations (sustained-release, topical).
• Strategic alliances in emerging markets.
• Stewardship programs to prolong efficacy.

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10. Key Factors Influencing Future Market Trajectory

Factor	Impact	Strategic Implication
Resistance emergence	Could curtail usage, shift demand	Invest in resistance monitoring, alternative therapies
Regulatory policies on antimicrobial stewardship	May restrict use, impact sales	Align with policies, promote appropriate usage
New formulation research and patents	Market expansion via innovative products	Focus R&D efforts on improved formulations
Global health initiatives targeting infectious diseases	Drive demand in endemic regions	Leverage public-private partnerships

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11. Key Takeaways

• Stable Market Backbone: Metronidazole remains essential, with consistent revenues driven by its affordability and broad-spectrum efficacy.

• Dynamic Resistance Landscape: Increasing resistance among key pathogens prompts prudent prescribing and continuous surveillance.

• Generics Dictate Pricing: Off-patent formulations dominate, keeping prices low; innovation largely centers around formulations rather than drug discovery.

• Emerging Markets as Growth Engines: African, Asian-Pacific, and Latin American markets exhibit higher growth potential, driven by disease burden and economic development.

• Innovation as a Differentiator: While primary sales are stable, future growth hinges on formulation innovations, resistance management, and strategic regulatory positioning.

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FAQs

Q1: Is metronidazole losing market share to newer antibiotics?
A: Currently, no significant market share loss is observed. Its affordability, established efficacy, and broad indications sustain its dominance. However, resistance and safety concerns necessitate cautious use, prompting research into alternative therapies.

Q2: How does antimicrobial resistance impact the future of metronidazole?
A: Resistance reduces clinical efficacy, potentially shrinking its utility. Monitoring resistance patterns and guideline updates are essential. Development of combination therapies and formulations may counteract resistance effects.

Q3: What role do regulatory agencies play in shaping the metronidazole market?
A: Agencies like the WHO, FDA, and EMA influence prescribing guidelines, approve new formulations, and advocate stewardship programs that indirectly affect demand and innovation pathways.

Q4: Are there promising alternative therapies to metronidazole?
A: Yes, agents like tinidazole and ornidazole are alternatives with potentially improved tolerability. New drugs are under investigation, but none have displaced metronidazole broadly.

Q5: How significant is the potential for topical or novel formulations in extending metronidazole’s market?
A: Significant. Topical and sustained-release formulations aim to improve compliance and efficacy, opening niche markets and potentially revitalizing growth.

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References

1. WHO. List of Essential Medicines. 2019.
2. IQVIA, Global Data Reports. 2022.
3. WHO. Global Antimicrobial Resistance Surveillance System (GLASS). 2021.
4. O'Neill J. Review on Antimicrobial Resistance. 2016.
5. CDC. Antibiotic Resistance Threats Report. 2019.
6. U.S. Patent and Trademark Office. Patent filings related to metronidazole. 2021.
7. Zhang, X. et al. "Nanotechnology in Antimicrobial Delivery," Journal of Drug Delivery Science and Technology, 2020.
8. CDC. Treatment Guidelines for Trichomoniasis. 2021.
9. US FDA. Guidance for Industry: Antibiotic Stewardship. 2018.
10. EMA. Guidelines on the Evaluation of Topical Antimicrobials. 2020.

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Conclusion

The market outlook for metronidazole remains cautiously optimistic, anchored by its proven efficacy and broad application spectrum. Continued vigilance against antimicrobial resistance, coupled with innovative formulations and strategic expansion into emerging markets, will influence its financial trajectory. Stakeholders should prioritize stewardship, innovation, and responsive regulatory engagement to sustain its crucial role in infectious disease management.

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This comprehensive analysis provides an authoritative resource for professionals seeking in-depth insights into the future landscape of metronidazole and its market dynamics.