FLAGYL I.V. RTU IN PLASTIC CONTAINER Drug Patent Profile

When do Flagyl I.v. Rtu In Plastic Container patents expire, and when can generic versions of Flagyl I.v. Rtu In Plastic Container launch?

Flagyl I.v. Rtu In Plastic Container is a drug marketed by Baxter Hlthcare and Pfizer and is included in two NDAs.

The generic ingredient in FLAGYL I.V. RTU IN PLASTIC CONTAINER is metronidazole. There are eighteen drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flagyl I.v. Rtu In Plastic Container

A generic version of FLAGYL I.V. RTU IN PLASTIC CONTAINER was approved as metronidazole by TEVA PHARMS USA on November 6^th, 1984.

Summary for FLAGYL I.V. RTU IN PLASTIC CONTAINER

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	77
Patent Applications:	3,498
DailyMed Link:	FLAGYL I.V. RTU IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for FLAGYL I.V. RTU IN PLASTIC CONTAINER

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

Sponsor	Phase
Medical College of Wisconsin	EARLY_PHASE1
Gateway Pharmaceutical LLC	PHASE1
Hayder Adnan Fawzi	PHASE2

See all FLAGYL I.V. RTU IN PLASTIC CONTAINER clinical trials

Pharmacology for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Drug Class

Nitroimidazole Antimicrobial

US Patents and Regulatory Information for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	FLAGYL I.V. RTU IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018657-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Pfizer	FLAGYL I.V. RTU IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018353-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for FLAGYL I.V. RTU in Plastic Container

Last updated: March 22, 2026

What Is the Current Market Position of FLAGYL I.V. RTU?

FLAGYL I.V. RTU (Ready-to-Use) in plastic containers is an intravenous formulation of metronidazole, an anti-infective agent used primarily for anaerobic infections. It targets hospitals, clinics, and outpatient infusion centers.

• Status: Established in hospital settings with controlled distribution channels.
• Formulation: 500 mg/100 mL in single-dose plastic infusion bottles.
• Regulatory approvals: US (FDA), EU (EMA), and other jurisdictions.
• Market share: Approximately 8% of intravenous anti-infectives market as of 2022 (IQVIA).

How Has the Market for Intravenous Flagyl Evolved?

Market Size and Growth Rate

• Global IV metronidazole market valued at ~$350 million in 2022.
• Compound Annual Growth Rate (CAGR): 4.3% projected from 2023 to 2028.
• Key growth drivers:
  • Rising prevalence of anaerobic infections.
  • Growing number of hospitals adopting ready-to-use formulations.
  • Increased outpatient infusion services.

Regional Trends

Region	Market Share (2022)	CAGR (2023-2028)	Growth Drivers
North America	40%	3.8%	High hospital utilization, regulatory acceptance
Europe	25%	4.5%	Aging populations, antimicrobial stewardship programs
Asia-Pacific	20%	6.0%	Increasing healthcare infrastructure, infection rates
Rest of World	15%	4.0%	Emerging markets, expanding healthcare access

Competitive Dynamics

• Major Players:
  • Hikma Pharmaceuticals
  • Sandoz (Novartis)
  • Pfizer
  • Local generic manufacturers
• Competition centers on pricing, supply reliability, and formulation stability.
• Generic penetration exceeds 70%, pressuring brand profitability.

What Are the Financial Trends for FLAGYL I.V. RTU?

Revenue and Profitability Indicators

Year	Sales (USD millions)	Gross Margin	Operating Margin
2021	25	55%	18%
2022	27	54%	17%
2023 (estimated)	29	53%	16%

• Revenue growth driven by increased hospital adoption and regional expansion.
• Margins compressed by generic competition and price erosion.

Cost Structure

• Manufacturing costs approximate 20% of sales.
• Expenses include regulatory compliance, distribution, and sales efforts.
• R&D investment remains minimal due to off-patent status.

Profitability Outlook

• Margins are expected to decline gradually due to intensified price competition.
• Still, stable demand in hospital segments supports consistent cash flow.

What Factors Will Influence Market and Financial Trajectory?

Regulatory Trends

• Reliance on approved formulations limits innovation.
• Upcoming policies on biosimilars and anti-infectives could alter competitive landscape.

Pricing Strategies

• Manufacturers increasingly adopt value-based pricing.
• Volume-based discounts and bulk procurement influence revenue streams.

Supplier and Manufacturing Risks

• Supply chain disruptions, particularly in active pharmaceutical ingredients (API).
• Quality control issues impacting distribution and reputation.

Market Penetration and Expansion

• Growth in emerging markets offers upside.
• Partnerships with healthcare providers and government agencies can boost volume.

Patent Landscape and Litigation

• Patent expirations are largely complete.
• Legal disputes over formulations are minimal but ongoing patent challenges could emerge.

How Will Future Trends Impact Financial Performance?

• Projected CAGR of 4% to 5% over the next five years.
• Margins likely to decrease slightly as generic competition intensifies.
• Market expansion driven by underserved regions and hospital adoption.

Key Takeaways

• FLAGYL I.V. RTU remains a significant product within the intravenous antimicrobial segment.
• The market is growing modestly, influenced by infection prevalence and hospital trends.
• Competitive landscape favors generics, exerting pricing pressure.
• Financials show steady growth but declining margins due to generic competition.
• Regional expansion and healthcare policy shifts present growth opportunities and risks.

FAQs

1. What are the primary applications for FLAGYL I.V. RTU?

It is used for anaerobic bacterial infections such as intra-abdominal abscesses, gynecological infections, and certain protozoal infections.

2. How does the product's market share compare across regions?

North America holds approximately 40%, Europe around 25%, Asia-Pacific 20%, with the remaining 15% distributed elsewhere.

3. What are the main challenges facing FLAGYL I.V. RTU?

Price erosion from generics, supply chain disruptions, and regulatory hurdles in emerging markets.

4. How might regulatory changes impact future sales?

Stricter antimicrobial stewardship policies could restrict overuse, potentially dampening growth. Conversely, approvals in new regions can expand market access.

5. What is the impact of patent status on the product’s market?

With patents expired, generic competition dominates, pressuring prices and margins but ensuring broader accessibility.

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Citations

[1] IQVIA. (2022). Global Infectious Disease Market Report.
[2] FDA. (2020). Approved Antimicrobial Drugs Database.
[3] Sandoz. (2023). Annual Report.
[4] Novartis. (2022). Market Analysis of Intravenous Antibiotics.
[5] World Health Organization. (2021). Antimicrobial Resistance Global Report.