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

Which patents cover Flagyl I.v. Rtu In Plastic Container, 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

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

Last updated: February 3, 2026

Investment Scenario Overview for FLAGYL I.V. RTU IN PLASTIC CONTAINER

FLAGYL I.V. RTU (Ready-To-Use) in a plastic container presents a targeted injectable formulation of MetroGel (metronidazole). Market demand is driven by its clinical applications in bacterial infections and parasitic diseases. The global intravenous antibiotic market is expanding at a compound annual growth rate (CAGR) of 7.2% from 2020 to 2027, reaching an estimated market size of $20 billion by 2027 [1]. This product aligns with increasing hospital and outpatient settings adopting IV therapies for serious infections, supporting a favorable growth outlook. The formulation's product features include convenience and reduced preparation time, appealing to hospitals and clinics.

Market and Competitive Landscape

Demand Drivers

• Rising prevalence of bacterial infections, including Clostridium difficile-associated diarrhea.
• Preference for IV antibiotics in hospital settings due to efficacy and rapid onset.
• Growth in outpatient infusion services and home healthcare segments.

Competitive Position

FLytal's key competitors include other IV metronidazole formulations:

• Generic IV metronidazole solutions available from multiple producers.
• New formulations with extended stability or improved delivery methods.
• Market leader status remains with established generics, but lack of patented barriers means price competition is intense.

Pricing and Market Entry

• Wholesale prices of IV metronidazole in the U.S. range from $0.50 to $2.00 per vial, depending on concentration and supplier.
• Entry barriers are low; patent expiry for leading formulations occurred circa 2010, leading to commoditization.
• Reimbursement rates via Medicare/Medicaid support hospital adoption, typically aligned with acquisition cost plus markup.

Regulatory and Supply Chain Considerations

Regulatory Pathway

• Submission to FDA via 505(b)(2) pathway allows for approval based on existing data with some supplementation.
• Stability testing for RTU formulation must preserve efficacy over 24 months.
• Good Manufacturing Practice (GMP) compliance necessary for production and distribution.

Manufacturing and Distribution

• Production in dedicated sterile facilities with quality standards suitable for injectable drugs.
• Packaging in tightly sealed plastic containers to prevent contamination.
• Cold chain logistics critical for maintaining stability, especially in warmer climates.

Financial and Investment Fundamentals

Revenue Projections

• Targeting hospital procurement through direct sales or hospital formularies.
• Estimated annual sales volume of 500,000 vials in the U.S., assuming steady market penetration.
• Price point of $1.00 per vial yields $500 million in gross revenue annually, with margins similar to generic injectable drugs (~10-30%).

Cost Structure

• Manufacturing costs (per vial): approximately $0.20-$0.40.
• Distribution and warehousing: 10-15% of sales.
• Regulatory, R&D, and marketing costs combined: 10-15% of revenue.
• Breakeven points expected within 3-5 years post-launch.

Risks

• Market saturation and price erosion.
• Competitive proliferation of generics.
• Supply chain disruptions affecting raw materials (active pharmaceutical ingredients).
• Regulatory delays or labeling issues.

Key Investment Considerations

• Market Size: Growing demand for IV antibiotics favors product uptake.
• Patent and IP Status: Likely limited; depends on formulation-specific patents if any.
• Competitive Intensity: High. Price competition is fierce, margins thin.
• Development Risk: Moderate, provided manufacturing and regulatory pathways are manageable.
• Revenue Potential: Substantial but contingent on effective market penetration and pricing strategy.

Key Takeaways

• FLAGYL I.V. RTU in plastic containers enters a mature but expanding market.
• Revenue potential is significant in hospital settings; margins are thin.
• Competitive landscape favors generics, limiting pricing power.
• Regulatory approval depends on stability and manufacturing standards, with a time frame of 1-2 years.
• Supply chain resilience and market access are critical success factors.

FAQs

1. What regulatory hurdles exist for launching FLAGYL I.V. RTU?

   • Ensuring stability data meet FDA standards; compliance with GMP; may require 1-2 years for approval.

2. How does pricing impact net margins?

   • Price erosion due to competition compresses margins; efficient manufacturing and distribution are key to maintaining profitability.

3. What are key patent considerations?

   • Likely no patent exclusivity; innovation focus on formulation stability and delivery method.

4. Is market saturation a concern?

   • Yes, extensive generic availability limits pricing power and market share expansion.

5. What logistical challenges are associated with distribution?

   • Maintaining cold chain logistics, managing inventory, and ensuring quality control in sterile environments.

References

[1] Market Research Future. "Intravenous Antibiotics Market Overview," 2021.