Nitrofuran Antibacterial Drug Class List

Drugs in Drug Class: Nitrofuran Antibacterial

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
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175-002	Jun 9, 2023		RX	Yes	Yes

Nitrofuran Antibacterial Market Analysis and Financial Projection

The nitrofuran antibacterial drug class, particularly nitrofurantoin, plays a critical role in treating urinary tract infections (UTIs) and addressing antibiotic resistance. Below is an analysis of the market dynamics and patent landscape shaping this sector.

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Market Dynamics

Growth Drivers

1. Rising UTI Prevalence
   UTIs are among the most common bacterial infections globally, affecting ~150 million people annually[5][6]. Women and the elderly are particularly vulnerable, driving demand for nitrofurantoin. The global UTI therapeutic market is projected to grow at a 3% CAGR, reaching $11.58 billion by 2031[5][12].

2. Antibiotic Resistance
   Nitrofurantoin remains effective against multidrug-resistant E. coli and other pathogens[14][19]. As resistance to fluoroquinolones and β-lactams rises[13], its unique mechanism—activated by bacterial nitroreductases to damage DNA/RNA—makes it a vital alternative[19].

3. Emerging Markets
   The Asia-Pacific region, led by India and China, is poised for rapid growth due to expanding pharmaceutical capacity and healthcare investments[1][8]. China alone accounts for ~10% of global nitrofurantoin API production[6].

4. Formulation Innovations
   Sustained-release formulations (e.g., Macrobid®) improve patient compliance. The API market is projected to grow from $400 million (2024) to $550 million by 2033 at a 4.5% CAGR[6][10].

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Key Challenges

1. Antimicrobial Resistance (AMR) Concerns
   Overuse risks resistance via mutations in nitroreductases (nfsA/nfsB)[19]. WHO warnings about AMR could limit long-term utility[6].

2. Regulatory Hurdles
   Stricter purity standards (e.g., >99% API)[8] and carcinogenicity concerns in veterinary use[17] complicate production and approval.

3. Competition from New Therapies
   Novel antibiotics (e.g., Recarbrio) and phage therapy research threaten market share[5].

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Patent Landscape

Key Innovations

1. Controlled-Release Formulations

   • US-2005202079-A1: Combines immediate and sustained-release nitrofurantoin components using sodium alginate and hypromellose[2][4].
   • US4122157A: Sustained-release tablets leveraging hydroxypropyl methylcellulose[9].

2. Next-Generation Nitrofurans

   • WO2009046536A1: Halogenated quinazolinyl nitrofurans exhibit broad-spectrum activity (MICs 0.03–0.125 µg/mL) against Bacillus, Staphylococcus, and drug-resistant strains[21].
   • Compound V/IITR06114: Novel derivatives with enhanced potency and efficacy against Pseudomonas aeruginosa[14][21].

3. Combination Therapies
   Synergy with deoxycholate or vancomycin improves bactericidal effects[15], while collateral sensitivity strategies target resistance mechanisms[15].

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Competitive Analysis

• Top Players: Teva Pharmaceutical Industries, Mylan (Viatris), and Merck dominate API production, holding ~60% market share[8].
• Strategic Moves: Capacity expansions in India/China, partnerships for distribution, and R&D investments in high-purity APIs (>99%)[8][27].
• Regional Trends:
  • North America/Europe: Hold ~75% market share due to advanced healthcare systems[1][6].
  • Asia-Pacific: Fastest-growing region (est. 6.1% CAGR) driven by cost-effective manufacturing[3][20].

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Future Outlook

• Market Growth: The nitrofurantoin API market is projected to reach $700 million by 2028[6], while the reagent segment grows at 5–7% CAGR[3].
• Innovation Focus: Next-gen nitrofurans with extended spectra and reduced resistance potential[14][21], alongside eco-friendly synthesis methods[8].
• Regulatory Impact: Stricter AMR guidelines and emphasis on sustainable production will shape R&D priorities[6][8].

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Highlight: "Novel nitrofurans with superior antimicrobial potency and improved pharmacological properties provide alternatives for severe infections caused by antibiotic-resistant pathogens." – PMC Articles[14]

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This analysis underscores nitrofurans’ enduring relevance in combating infections, bolstered by strategic innovations and evolving market dynamics. Stakeholders must balance growth opportunities with regulatory and resistance challenges to sustain long-term impact.

References

1. https://github.com/jaspartatin/Market-Research-Report-List-1/blob/main/nitrofurantoin-api-market-global-outlook-and-forecast-2022-2028-market.md
2. https://patents.justia.com/patent/20050202079
3. https://github.com/jullselai/Market-Research-Report-List-1/blob/main/nitrofurantoin-reagent-market-global-outlook-and-forecast-2022-2028-market.md
4. https://pubchem.ncbi.nlm.nih.gov/patent/US-2005202079-A1
5. https://www.drugpatentwatch.com/p/drug-sales/drugname/MACROBID
6. https://www.verifiedmarketreports.com/product/nitrofurantoin-api-market/
7. https://patents.google.com/patent/US3290213A/en
8. https://patents.google.com/patent/US4122157A/en
9. https://www.promarketreports.com/reports/nitrofurantoin-api-59371
10. https://www.verifiedmarketreports.com/product/nitrofurantoin-api-market/
11. https://patents.justia.com/patent/20050202079
12. https://www.drugpatentwatch.com/p/drug-sales/drugname/MACROBID
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC3021209/
14. https://pmc.ncbi.nlm.nih.gov/articles/PMC8266087/
15. https://journals.plos.org/plospathogens/article?id=10.1371%2Fjournal.ppat.1009663
16. https://www.verifiedmarketreports.com/product/nitrofurantoin-api-market/
17. https://www.merckvetmanual.com/pharmacology/antibacterial-agents/nitrofurans-use-in-animals
18. https://www.drugpatentwatch.com/p/drug-sales/drugname/MACROBID
19. https://pmc.ncbi.nlm.nih.gov/articles/PMC10414118/
20. https://www.promarketreports.com/reports/nitrofurantoin-reagent-59374
21. https://patents.google.com/patent/WO2009046536A1/en
22. https://www.drugpatentwatch.com/p/drug-sales/drugname/MACROBID
23. https://github.com/jaspartatin/Market-Research-Report-List-1/blob/main/nitrofurantoin-api-market-global-outlook-and-forecast-2022-2028-market.md
24. https://patents.google.com/patent/US4500516A/en
25. https://github.com/jullselai/Market-Research-Report-List-1/blob/main/nitrofurantoin-reagent-market-global-outlook-and-forecast-2022-2028-market.md
26. https://www.verifiedmarketreports.com/product/nitrofurantoin-api-market/
27. https://www.promarketreports.com/reports/nitrofurantoin-api-59371