NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details

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

Nitrofurantoin, macrocrystalline is the generic ingredient in three branded drugs marketed by Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-seven suppliers are listed for this compound.

Summary for NITROFURANTOIN, MACROCRYSTALLINE

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	15
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
DailyMed Link:	NITROFURANTOIN, MACROCRYSTALLINE at DailyMed

Recent Clinical Trials for 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, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN, MACROCRYSTALLINE

Drug Class

Nitrofuran Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for 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, MACROCRYSTALLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mankind Pharma	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217272-003	Mar 21, 2023	AB	RX	No	No
Impax Labs Inc	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	073671-001	Jan 28, 1993	AB	RX	No	No
Watson Labs	NITROFURANTOIN MACROCRYSTALLINE	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	070249-001	Jun 24, 1988		DISCN	No	No
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-002	Jun 25, 2021	AB	RX	No	No
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

NITROFURANTOIN, MACROCRYSTALLINE Market Analysis and Financial Projection

Last updated: February 13, 2026

Market Dynamics for Macrocrystalline Nitrofurantoin

Market Size and Segmentation
Macrocrystalline nitrofurantoin is primarily used to treat uncomplicated urinary tract infections (UTIs). The global antibiotic market for UTIs, which includes drugs like nitrofurantoin, was valued at approximately $4.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2028 [1].

Key Geographies

• North America: Dominates with a market share exceeding 40%, driven by high UTI incidence, antibiotic prescribing rates, and robust healthcare infrastructure.
• Europe: Accounts for roughly 25% of the market, with growing prescription use in outpatient settings.
• Asia-Pacific: Exhibits the fastest growth, with a CAGR near 6.1%, attributed to increasing urbanization and antibiotic accessibility.

Patent Status and Competition
Macrocrystalline nitrofurantoin is off-patent worldwide, resulting in a highly competitive generic market. Major pharmaceutical companies primarily manufacture generics, with limited R&D pipeline activity for new formulations [2].

Regulatory Landscape
Regulatory agencies such as the FDA and EMA approve both brand-name and generic products. No new patent protections or significant regulatory changes have been reported recently, supporting lower pricing pressures.

Financial Trajectory

Revenue Trends
Historical revenues for nitrofurantoin drugs fluctuate with prescription volumes. In the US, generic nitrofurantoin sales approximate $200 million annually, with a slight decline observed over the past five years due to generic price competition and increasing antibiotic resistance concerns [3].

Pricing Dynamics
Prices for macrocrystalline nitrofurantoin have steadily decreased, with wholesale acquisition costs (WAC) dropping approximately 15% over the past three years. Price erosion is driven by generic competition and payer pressure.

Research & Development Investment
R&D efforts are limited, primarily focused on reformulations or combination products to address resistance or improve patient adherence. Significant novel pipeline activity is absent, indicating a focus on generic manufacturing.

Market Entry Barriers
The low novelty and patent expiry reduce barriers; however, manufacturing quality standards, regulatory approval processes, and market penetration costs influence profitability. Patent-stacking or market exclusivity is minimal.

Market Challenges and Opportunities

Challenges

• Antibiotic resistance: Increasing resistance rates threaten to diminish efficacy, pushing prescribers toward alternative therapies.
• Price Competition: Intense generic competition reduces profit margins.
• Prescribing Practices: Shift toward alternative antibiotics or non-pharmacological management in certain regions.

Opportunities

• Formulation Innovations: Extended-release formulations or combination therapies could provide differentiation.
• Resistance Management: Developing stewardship programs and monitoring resistance patterns may sustain demand.
• Expanding into emerging markets with rising UTI incidence and improving healthcare access.

Summary

The macrocrystalline nitrofurantoin segment exists within a mature, highly competitive, and price-sensitive environment. The revenue remains stable but slight declines are probable given resistance issues and pricing pressures. Future growth prospects hinge on formulation innovations and geographic expansion, rather than patent protection or novel drug development.

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Key Takeaways

• Macrocrystalline nitrofurantoin's revenue is approximately $200 million annually in the US, with global sales facing downward pressure.
• The drug is off-patent, leading to a commoditized market with high generic competition.
• Resistance emergence diminishes effective demand, influencing prescribing trends.
• Price erosion and regulatory hurdles limit profit margins for manufacturers.
• Growth opportunities exist in formulation innovation and market expansion in emerging economies.

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FAQs

1. Why is macrocrystalline nitrofurantoin off-patent?
It was approved decades ago, and patent protections have expired globally, enabling the widespread manufacture of generics.

2. How does antibiotic resistance impact this drug’s market?
Rising resistance in UTI pathogens reduces the drug’s effectiveness, potentially leading to decreased usage as clinicians switch to alternative therapies.

3. Are there any recent regulatory changes affecting macrocrystalline nitrofurantoin?
No significant regulatory changes have been reported in recent years; approvals continue under existing generic pathways.

4. What are the main competitors in this market?
Generic manufacturers, including Teva, Mylan, and Lupin, dominate supply, with little differentiation beyond price.

5. What future innovations could prolong the drug’s market relevance?
Formulation improvements, such as sustained-release versions, and combination therapies aiming to combat resistance are potential avenues.

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References

[1] MarketsandMarkets, "Antibiotics Market by Type," 2022.
[2] EvaluatePharma, "Generic Drug Pipeline," 2023.
[3] IQVIA, "US Prescription Data for Nitrofurantoin," 2022.