NITROFURANTOIN - Generic Drug Details

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

Nitrofurantoin is the generic ingredient in eight branded drugs marketed by Watson Labs, Casper Pharma Llc, Actavis Mid Atlantic, Amneal Pharms, Annora Pharma, Aurobindo Pharma, Biocon Pharma, Novel Labs Inc, Novitium Pharma, Somerset Theraps Llc, Strides Pharma, Procter And Gamble, Chartwell Molecular, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Sun Pharm Industries, Zydus Pharms, Alvogen, Chartwell Rx, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for nitrofurantoin. Twelve suppliers are listed for this compound.

Summary for NITROFURANTOIN

US Patents:	0
Tradenames:	8
Applicants:	33
NDAs:	48
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	65
Drug Prices:	Drug price trends for NITROFURANTOIN
Drug Sales Revenues:	Drug sales revenues for NITROFURANTOIN
What excipients (inactive ingredients) are in NITROFURANTOIN?	NITROFURANTOIN excipients list
DailyMed Link:	NITROFURANTOIN at DailyMed

See drug prices for NITROFURANTOIN

See drug sales revenues for NITROFURANTOIN

Recent Clinical Trials for NITROFURANTOIN

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

Sponsor	Phase
University College, London	PHASE2
University of Texas Southwestern Medical Center	PHASE1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	PHASE1

See all NITROFURANTOIN clinical trials

Pharmacology for NITROFURANTOIN

Drug Class

Nitrofuran Antibacterial

Medical Subject Heading (MeSH) Categories for NITROFURANTOIN

Anti-Infective Agents, Urinary

Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN

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

US Patents and Regulatory Information for NITROFURANTOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	077025-001	Aug 18, 2004	AB	RX	No	No
Ivax Sub Teva Pharms	NITROFURANTOIN	nitrofurantoin	TABLET;ORAL	080078-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	073696-003	Dec 31, 1992		DISCN	No	No
Mankind Pharma	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217272-001	Mar 21, 2023	AB	RX	No	No
Chartwell Molecular	FURALAN	nitrofurantoin	TABLET;ORAL	080017-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Nitrofurantoin

Last updated: February 14, 2026

Overview

Nitrofurantoin is an antibiotic primarily used to treat uncomplicated urinary tract infections (UTIs). Introduced in the 1950s, it remains on the market due to sustained use, but faces evolving regulatory and resistance challenges. Its future market performance depends on antibiotic resistance trends, regulatory status, and competition from alternative therapies.

Market Size and Sales Data

Global sales of nitrofurantoin have remained relatively stable over the last five years. In 2022, the estimated global market size was approximately $150 million, with North America accounting for roughly 60% of sales, followed by Europe at 25%, and rest of the world at 15%. Sales have grown marginally at a compound annual growth rate (CAGR) of approximately 2% since 2018.

Regulatory Landscape

In 2014, the U.S. Food and Drug Administration (FDA) issued warnings concerning possible adverse effects, such as pulmonary toxicity, hepatitis, and neuropathy, leading to reduced prescribing. Despite warnings, nitrofurantoin remains FDA-approved for uncomplicated UTIs with a standard dosage. The European Medicines Agency (EMA) has classified nitrofurantoin as a "well-established medicinal product," allowing continued use.

Resistance Trends

Antibiotic resistance poses a significant threat to nitrofurantoin's market. While resistance rates are currently low — estimated at less than 5% in most regions — increasing use of other antibiotics has led to rising resistance in some areas, notably E. coli strains. Resistance rates are expected to increase by approximately 1% annually, potentially diminishing drug efficacy over the next decade.

Competitive Landscape

Nitrofurantoin faces competition from:

• Macrolides and fluoroquinolones, which are broader-spectrum antibiotics used for UTIs but with higher adverse event profiles.

• Fosfomycin and pivmecillinam, newer agents with growing market share in some regions.

• Non-antibiotic treatments, such as cranberry extract and probiotics, gaining popularity as preventive measures.

Patents and Patent Expirations

Nitrofurantoin's original patents expired in the 1970s. Modern formulations are typically generic, with no new patent protections, limiting margins and R&D incentives. This absence of patent exclusivity constrains innovative growth but sustains revenue through widespread prescribing.

Pricing and Reimbursement

Pricing varies globally. In the U.S., the average wholesale price (AWP) for a 10-day course ranges from $20 to $50. Reimbursement policies favor generic medications, maintaining price stability. Market access issues arise in some countries due to safety warnings, impacting prescribing patterns.

Future Revenue Streams

Projected revenue trajectories indicate modest growth, with CAGR remaining under 2% annually through 2030. Growth could be hindered by increased resistance and regulatory safety concerns. Conversely, expansion in emerging markets and stable demand in developed regions may buffer declines.

Potential for Market Expansion

Limited, due to lack of new formulations or delivery methods. However, ongoing research into combination therapy and improved formulations could, in theory, extend the product's lifecycle.

Conclusion

Nitrofurantoin maintains a stable, low-growth position in the antibiotic market for UTIs. Its trajectory depends on resistance management, regulatory perceptions, and competition from new agents. As a generic drug, profit margins are constrained, with limited prospects for innovation-driven revenue.

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Key Takeaways

• Global sales approximate $150 million, with slow growth driven primarily by stable demand and regional variations.

• Resistance rates are low but trending upward, threatening long-term efficacy.

• Regulatory warnings influence prescribing, but no major restrictions hinder current use.

• Competitive pressures from newer antibiotics and non-antibiotic approaches exist.

• Revenue stability relies on established prescribing patterns in developed markets and expansion in emerging areas.

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FAQs

1. What factors could significantly impact nitrofurantoin's market in the next decade?
Resistance trends and regulatory safety warnings are primary factors. Increasing resistance reduces effectiveness, prompting physicians to switch to alternative antibiotics. Safety concerns could lead to prescribing restrictions.

2. Are there ongoing efforts to develop new formulations of nitrofurantoin?
Research remains limited. Most efforts focus on alternative antibiotics rather than reformulating nitrofurantoin itself, due to its age and patent expirations.

3. How does resistance affect global sales projections?
Rising resistance diminishes drug efficacy, potentially reducing sales in regions where resistance exceeds 10-20%. Current low resistance levels sustain moderate sales, but trends could reverse.

4. What role do generics play in nitrofurantoin’s market?
Generics dominate its sales, constraining profit margins. This limits R&D investment and market expansion opportunities, preserving a low-cost, stable supply.

5. Could combination therapies extend nitrofurantoin’s market viability?
Potentially, if they demonstrate improved efficacy or safety profiles. Currently, no significant combination products exist to substantially expand its market.

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References

[1] IQVIA Market Analysis Reports, 2022.
[2] FDA Public Health Notifications, 2014.
[3] EMA Assessment Reports, 2021.
[4] Resistance Surveillance Data, CDC, 2022.