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Last Updated: March 19, 2026

FLAGYL Drug Patent Profile


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When do Flagyl patents expire, and what generic alternatives are available?

Flagyl is a drug marketed by Pfizer and Baxter Hlthcare and is included in five NDAs.

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

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Questions you can ask:
  • What is the 5 year forecast for FLAGYL?
  • What are the global sales for FLAGYL?
  • What is Average Wholesale Price for FLAGYL?
Summary for FLAGYL
US Patents:0
Applicants:2
NDAs:5

US Patents and Regulatory Information for FLAGYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer FLAGYL metronidazole CAPSULE;ORAL 020334-001 May 3, 1995 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer FLAGYL I.V. RTU IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 018353-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer FLAGYL ER metronidazole TABLET, EXTENDED RELEASE;ORAL 020868-001 Nov 26, 1997 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer FLAGYL metronidazole TABLET;ORAL 012623-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer FLAGYL metronidazole TABLET;ORAL 012623-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare FLAGYL I.V. RTU IN PLASTIC CONTAINER metronidazole INJECTABLE;INJECTION 018657-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: February 3, 2026

mmary
Flagyl (metronidazole) is a well-established antimicrobial agent used primarily for protozoal infections and anaerobic bacteria. Despite its widespread use, its patent expired decades ago, positioning it as a generic drug. Investment prospects focus on niche applications, resistance management, and potential reformulations. Fundamental analysis highlights limited growth potential without new patent protections or novel formulations.


Is Flagyl (metronidazole) a viable investment opportunity?

As a generic drug, Flagyl's revenue derives from volume sales rather than exclusive rights. The core market consists of hospital and outpatient settings for conditions like bacterial vaginosis, trichomoniasis, and anaerobic infections. Patent expirations in the early 2000s have minimized exclusivity, leading to intense price competition and thin margins among producers. Investment in Flagyl itself presents limited growth prospects without innovation.

What is the current market landscape for Flagyl?

Market Size and Usage

  • The global antimicrobial market was valued at approximately $60 billion in 2021, with broad antibiotic segments dominating.
  • Flagyl accounted for an estimated $500 million to $1 billion globally in sales in 2022, primarily driven by generic formulations [1].
  • Major markets include the US, Europe, and emerging markets with high infection rates.

Competition and Pricing Dynamics

  • Multiple generic manufacturers produce metronidazole, leading to intense price competition.
  • Prices in the US range from $0.10 to $0.50 per tablet, depending on volume and supplier.
  • Market share is fragmented, with no single producer holding a dominant position.

Regulatory and Patent Status

  • Patents expired in early 2000s, eliminating exclusivity.
  • Regulatory filings are straightforward as an off-patent drug, lowering barriers to entry for generics.

What are the fundamental drivers impacting future sales?

Demand Stability and Limitations

  • Demand remains steady for infections treated with Flagyl.
  • However, rising antimicrobial resistance (AMR) is reducing efficacy in some indications, impacting clinical use.
  • Alternative treatments (e.g., tinidazole) compete in certain applications.

Innovations and Reformulations

  • No recent reformulations or new delivery systems (e.g., extended-release) have gained approval.
  • Few companies are investing in reformulating Flagyl due to limited profitability; R&D in this space is minimal.

Resistance and Safety Concerns

  • Resistance in certain pathogenic strains (e.g., Trichomonas vaginalis) pose a threat.
  • Safety concerns include potential neurotoxicity and carcinogenicity at high doses, prompting cautious use.

What investment strategies are relevant for Flagyl?

  • Generic Market Play: Investing in companies with established manufacturing capacity and low-cost production enables margin preservation amid price erosion.
  • Niche Applications: Targeting regions or applications where resistance is low, or where alternatives are limited, may sustain demand.
  • Diagnosis-Driven Prescriptions: Companies involved in diagnostics to ensure targeted therapy could benefit as antimicrobial stewardship tightens.

What are the risks and limitations?

  • Market Saturation: Limited upside due to past patent expirations and generic competition.
  • Resistance and Usage Decline: Growing resistance reduces scope of use, driven by global AMR initiatives.
  • Regulatory Shifts: Increased regulation around antimicrobial stewardship could restrict use.
  • Innovation Gap: Lack of new formulations or indications diminishes long-term growth.

Key Takeaways

  • Flagyl's market is mature, with sales driven by generic volume rather than innovation or exclusivity.
  • Price competition constrains margins; demand remains stable but susceptible to resistance.
  • No significant innovation or reformulation efforts are underway for Flagyl.
  • Future growth depends on niche markets, regional demand, and stewardship policies.
  • Investors should consider exposure to generic manufacturers with low-cost operations rather than the drug itself.

FAQs

Q1: Is there any potential for new patent protections for Flagyl?
No; the original patents expired in the early 2000s. No recent filings suggest new patents on the core molecule.

Q2: Could reformulation or combination therapies revive Flagyl sales?
Unlikely; there are limited incentives for large-scale R&D due to low margins and patent barriers.

Q3: How does antimicrobial resistance impact Flagyl's future?
It restricts use in certain infections, reducing overall demand. Resistance varies geographically and by strain.

Q4: Which regions offer the best investment prospects for Flagyl?
Emerging markets with high infection prevalence and limited access to alternative therapies offer growth opportunities.

Q5: Are there any legal or regulatory risks specific to Flagyl?
Risks stem from antimicrobial stewardship policies and potential safety concerns, which could influence prescribing practices.


References

[1] Global Data, "Antimicrobial Market Size, Share & Trends," 2022.

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