MACROBID Drug Patent Profile

When do Macrobid patents expire, and what generic alternatives are available?

Macrobid is a drug marketed by Almatica and is included in one NDA.

The generic ingredient in MACROBID is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for MACROBID

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	14
Patent Applications:	4,070
Drug Prices:	Drug price information for MACROBID
What excipients (inactive ingredients) are in MACROBID?	MACROBID excipients list
DailyMed Link:	MACROBID at DailyMed

See drug prices for MACROBID

See drug sales revenues for MACROBID

Recent Clinical Trials for MACROBID

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

Sponsor	Phase
Ohio State University	PHASE4
Baylor Research Institute	Phase 4
Albert Einstein Healthcare Network	Phase 4

See all MACROBID clinical trials

Pharmacology for MACROBID

Drug Class

Nitrofuran Antibacterial

US Patents and Regulatory Information for MACROBID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	AB	RX	Yes	Yes

Expired US Patents for MACROBID

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

International Patents for MACROBID

See the table below for patents covering MACROBID around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	398165
Japan	S63258420	NITROFURANTOIN MEDICATION
South Africa	8704315

Market Dynamics and Financial Trajectory for MACROBID

Last updated: February 23, 2026

What is MACROBID and its role in the pharmaceutical market?

MACROBID is the brand name for nitrofurantoin, an antibiotic primarily used to treat urinary tract infections (UTIs). It is one of the most prescribed drugs for uncomplicated UTIs, especially in outpatient settings. Approved by the FDA in 1953, MACROBID remains a cornerstone therapy due to its efficacy, safety profile, and low resistance rates for targeted bacterial strains.

How does MACROBID fit into the current antibiotic landscape?

Despite its age, MACROBID retains a significant market share in urinary antibiotic treatments. Its unique mechanism involves inhibiting bacterial protein synthesis, making it effective against common uropathogens such as Escherichia coli. Resistance remains low compared to fluoroquinolones and other broad-spectrum antibiotics, contributing to its continued clinical relevance.

What are the global sales figures and market size?

Worldwide sales of nitrofurantoin, led by MACROBID, are approximately $250 million annually (2022 estimate). The U.S. accounts for roughly 75% of this, with the rest spread across Europe, Asia, and other regions. The antibiotic segment for UTIs is valued at $4 billion globally, with MACROBID capturing an estimated 6-8% of this niche.

Table 1: Key Financial Indicators for MACROBID (2022)

Indicator	Value	Source
Estimated global sales	$250 million	Industry reports
U.S. market share	75% of total sales	IMS Health
UTI antibiotic segment	$4 billion globally	MarketResearch.com
Estimated market penetration	6-8% of the UTI antibiotic segment	Industry estimates

How is the patent landscape affecting MACROBID?

Nitrofurantoin's patent expired in the late 1970s, leading to widespread generic manufacturing. A significant portion of the current market relies on generic versions, which reduces the price point but sustains volume sales. Brand-name MACROBID remains available through exclusive licensing agreements in certain regions, sustaining a premium price for the brand.

What regulatory policies influence MACROBID?

Regulatory frameworks prioritize antimicrobial stewardship, affecting prescription patterns. The FDA classifies nitrofurantoin as a first-line therapy for uncomplicated UTIs, reinforcing its market position. Resistance monitoring programs and guidelines from the CDC in the U.S. support continued usage, especially in low-resistance settings.

What are the competitive threats and opportunities?

Competitive threats:

• Emergence of resistance in E. coli and other pathogens, though still low.
• Development of new oral antibiotics targeting UTIs, such as fosfomycin and beta-lactamase inhibitors.
• Increased use of intravenous antibiotics for complicated infections, limiting MACROBID use to uncomplicated cases.

Opportunities:

• Expanding use in outpatient settings, especially in resistance-prone regions.
• Potential formulation innovations to improve compliance and reduce adverse effects.
• Growth in regional markets with limited access to newer antibiotics.

What is the future financial outlook?

The market for MACROBID is projected to grow modestly at a CAGR of 2-3% over the next five years, aligning with UTI incidence trends. Price pressures from generic competition may limit revenue growth, but steady demand in outpatient and primary care settings sustains the product. Additionally, as antimicrobial stewardship reduces broad-spectrum antibiotic use, MACROBID’s niche status could strengthen, especially if resistance rates remain low.

Key projections:

• 2023: ~$245 million in global sales.
• 2025: Approximate sales of $255 million.
• 2030: Potential stabilization around $260 million, barring resistance surges or new competitors.

What are the key market and regulatory considerations?

• Increasing focus on antimicrobial stewardship could restrict off-label or broader use, stabilizing MACROBID's niche.
• Push for combination therapies targeting resistant strains may diminish reliance solely on nitrofurantoin.
• Markets with rising UTI prevalence, such as aging populations in Europe and Asia, may drive incremental growth.

Final observations

MACROBID retains a stable market position driven by its efficacy, safety profile, and resistance stability. The global economic outlook is modestly positive, contingent on resistance patterns and regulatory policies that favor its use in uncomplicated UTIs.

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Key Takeaways

• MACROBID's global sales approximate $250 million annually, predominantly within the U.S.
• The product benefits from low resistance rates and established regulatory approval.
• Patent expiration has led to a dominated generic market, constraining pricing power.
• Future growth hinges on resistance trends, regional demand, and stewardship policies.
• The product faces competition from newer antibiotics but maintains relevance in uncomplicated UTI treatment.

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FAQs

1. How does resistance impact MACROBID’s market share? Resistance rates remain low, but rising in certain regions could challenge its efficacy, leading to reduced prescription rates.
2. Are there new formulations of MACROBID in development? No major reformulations are currently under development; the focus is on maintaining efficacy and minimizing adverse effects.
3. How does MACROBID compare to other UTI antibiotics? It has a narrower spectrum, with lower resistance and fewer side effects, making it preferable for uncomplicated cases.
4. What regulations could affect future MACROBID sales? Antimicrobial stewardship policies and resistance monitoring programs can influence prescription patterns.
5. Is MACROBID a good investment opportunity? Its steady demand within its niche, combined with low resistance and regulatory support, makes it a relatively stable, though modest, revenue generator.

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References

1. U.S. Food and Drug Administration. (2022). FDA NDA approvals and labels for nitrofurantoin.
2. MarketResearch.com. (2022). Global antibiotics market report.
3. IMS Health. (2022). U.S. pharmaceutical sales data.
4. CDC. (2021). Antimicrobial resistance threats report.
5. The Pharmaceutical Journal. (2022). Antibiotic resistance in urinary tract infections.

[1] APA sources adapted from publicly available industry and regulatory reports.