NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details

What are the generic sources for nitrofurantoin; nitrofurantoin, macrocrystalline and what is the scope of patent protection?

Nitrofurantoin; nitrofurantoin, macrocrystalline is the generic ingredient in two branded drugs marketed by Almatica, Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Omsav Pharma, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-nine suppliers are listed for this compound.

Summary for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	29
Clinical Trials:	3
DailyMed Link:	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE at DailyMed

Recent Clinical Trials for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

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

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	Phase 3
MJM Bonten	Phase 3

See all NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Drug Class

Nitrofuran Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

J01XE	Nitrofuran derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Omsav Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217073-001	Nov 3, 2023	AB	RX	No	No
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	AB	RX	Yes	Yes
Ranbaxy Labs Ltd	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076951-001	Mar 30, 2005		DISCN	No	No

Expired US Patents for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	4,772,473
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	4,798,725

Market and Financial Trajectory of Nitrofurantoin and Macrocrystalline Nitrofurantoin

Last updated: February 14, 2026

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What Is the Current Market Demand for Nitrofurantoin and Its Variants?

Nitrofurantoin, especially its macrocrystalline formulation, is an established antibiotic used primarily for uncomplicated urinary tract infections (UTIs). Market demand remains steady due to its longstanding efficacy, generic availability, and favorable safety profile.

estimates from IQVIA indicate that global sales of nitrofurantoin reached approximately $300 million in 2022, with North America accounting for roughly 60%. Growth rates are modest, around 2-3% annually, driven by regional prescribing patterns and antimicrobial resistance considerations.

Key points:

• Predominantly used in the U.S. and European markets.
• Increasing resistance to other antibiotics sustains demand for nitrofurantoin.
• Generic formulations dominate sales, limiting pricing power and R&D investment.

How Do Market Dynamics Affect Nitrofurantoin’s Commercial Outlook?

Competitive Landscape:

The U.S. Food and Drug Administration (FDA) approved nitrofurantoin in 1953. Several generics are available, with the top five manufacturers controlling over 85% of volume. Limited pipeline activity and low R&D investment sustain the generic-dominated environment.

Regulatory and Resistance Issues:

The emergence of antimicrobial resistance (AMR) poses a challenge but also an opportunity, as nitrofurantoin remains effective against resistant strains of Escherichia coli. Resistance rates are rising but are still below 10% in most regions, preserving market relevance.

Patent Status:

Nitrofurantoin is off-patent globally. No recent patent filings for new delivery methods or formulations, such as macrocrystalline variants, have attracted significant R&D interest. Manufacturers focus on cost-effective generic production rather than innovation.

What Is the Financial Trajectory for Nitrofurantoin and Macrocrystalline Variants?

Revenue Projections:

The global market for nitrofurantoin is expected to grow at a compound annual growth rate (CAGR) of approximately 2% through 2027. Leading generics could see revenues close to $360 million by 2027, driven by consistent prescribing patterns.

Cost Structure and Pricing:

Manufacturing costs remain low due to established synthesis routes. Wholesale prices for nitrofurantoin tablets range from $0.05 to $0.20 per tablet, with macrocrystalline formulations priced similarly. Price erosion due to generic competition limits margins.

Investment and R&D:

Limited R&D investments are observed in this segment, with most revenue derived from established formulations. Efforts primarily focus on manufacturing efficiencies rather than innovation or new indications.

Are Any Market or Regulatory Trends Expected to Influence Future Trajectory?

Antimicrobial Stewardship:

Efforts to reduce unnecessary antibiotic use may modestly constrain growth. However, stewardship policies favor narrow-spectrum agents like nitrofurantoin for UTIs, supporting consistent demand.

New Formulations:

Development of extended-release or combination formulations has not been prominent, possibly due to the low profit margins and high regulatory hurdles.

Emerging Resistance and Diagnostics:

Advances in rapid diagnostics to precisely identify appropriate antibiotic therapy could positively influence nitrofurantoin utilization.

What Are the Key Factors Impacting the Drug’s Financial Outlook?

• Generic Competition: Maintains low prices, caps revenue growth.
• Resistance Trends: Slight increases in resistance could limit future use but currently do not threaten market share.
• Regulatory Environment: No new regulations significantly impact current approvals or market access.
• Manufacturing Costs: Stable, supporting continued profitability at current price points.
• Pipeline Innovation: Minimal; focuses on existing formulations without substantial R&D pipelines.

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Key Takeaways

• Nitrofurantoin remains a low-cost, widely used antimicrobial for UTIs, especially in North America and Europe.
• The market grows slowly, about 2-3% annually, influenced by resistance dynamics and prescribing habits.
• Generic competition dominates, limiting revenue potential but providing stable cash flow for manufacturers.
• No significant R&D trends or new formulations are emerging; market stability relies on existing drugs and resistance patterns.
• Regulatory and antimicrobial stewardship policies are unlikely to drive dramatic change in the near term.

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FAQs

1. How does resistance impact the future of nitrofurantoin?
Resistance rates are currently below 10% in most regions, but rising resistance could reduce efficacy, leading to decreased use over time. Continuous monitoring is essential.

2. Are there any new formulations of nitrofurantoin in development?
Development has been limited; most focus remains on generic manufacturing. Innovative formulations such as extended-release versions are not publicly in advanced stages.

3. What region offers the greatest growth potential for nitrofurantoin?
North America remains the largest market with stable demand. Emerging markets may see incremental growth, contingent on healthcare infrastructure and antibiotic stewardship policies.

4. How do antimicrobial stewardship programs influence nitrofurantoin sales?
Stewardship protocols favor narrow-spectrum agents like nitrofurantoin for uncomplicated UTIs, maintaining steady demand but preventing overuse.

5. Is there a risk of regulatory changes affecting nitrofurantoin?
Current regulatory pathways are stable; no imminent policy shifts threaten market access based on recent approvals and usage patterns.

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Citations

[1] IQVIA. 2022 Pharmaceutical Market Data.
[2] FDA. Approval history and regulatory status of nitrofurantoin.
[3] CDC. Antimicrobial resistance surveillance reports.
[4] MarketWatch. Antibiotics market analysis report, 2023.