Nitrofurantoin, macrocrystalline - Generic Drug Details

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

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-eight suppliers are listed for this compound.

Summary for nitrofurantoin, macrocrystalline

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	15
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	6,478
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
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-002	Jun 25, 2021	AB	RX	No	No
Novel Labs Inc	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	203233-002	Jul 9, 2018	AB	RX	No	No
Aurobindo Pharma Usa	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	074967-001	Jul 9, 1997	AB	RX	No	No

Nitrofurantoin, macrocrystalline Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nitrofurantoin, Macrocrystalline

Introduction

Nitrofurantoin, a broad-spectrum antibiotic introduced in 1953, has been a staple in the treatment of urinary tract infections (UTIs). The macrocrystalline form of nitrofurantoin has gained significant attention due to its efficacy, safety profile, and convenience. Here, we delve into the market dynamics and financial trajectory of macrocrystalline nitrofurantoin.

Market Demand and Growth

The demand for nitrofurantoin, particularly the macrocrystalline form, has seen a significant surge in recent years. This increase is largely attributed to new guidelines that have repositioned nitrofurantoin as a first-line therapy for uncomplicated lower urinary tract infections (UTIs)[1].

Regulatory Approvals and Reclassification

In various regions, regulatory approvals and reclassifications have contributed to the drug's market growth. For instance, in New Zealand, the modified release formulation of nitrofurantoin, Macrobid, gained regulatory approval in October 2020 and was fully funded on the Pharmaceutical Schedule from March 2021. This move has made the treatment more accessible and convenient, with a twice-daily dosing regimen, which is expected to improve adherence and reduce treatment failures[3].

Competitive Landscape

The antibiotic market for UTI treatments is competitive, with other antibiotics like fluoroquinolones and amoxicillin-clavulanic acid also being used. However, the overuse of fluoroquinolones has raised concerns about resistance and side effects, making nitrofurantoin a more favorable option due to its lower resistance rates and targeted activity in the urinary tract[1].

Market Share and Prescription Trends

Nitrofurantoin's market share has increased as it becomes a preferred choice for treating uncomplicated UTIs. The drug's effectiveness against drug-resistant uropathogens and its lower side effect profile compared to other antibiotics have contributed to its growing prescription rates. Studies have shown that macrocrystalline nitrofurantoin offers a higher cure rate and lower incidence of side effects compared to microcrystalline forms[3].

Financial Trajectory

The financial performance of nitrofurantoin, particularly the macrocrystalline form, is closely tied to its increasing market demand and regulatory approvals.

Revenue Growth

The revenue from nitrofurantoin sales has seen a steady increase as the drug becomes more widely accepted as a first-line treatment for UTIs. The convenience of the modified release formulation, such as Macrobid, which requires only twice-daily dosing, has improved patient adherence and reduced treatment failures, further boosting sales[3].

Cost-Effectiveness

Nitrofurantoin is generally cost-effective compared to other antibiotics. The reduced need for frequent dosing and the lower incidence of side effects contribute to lower overall treatment costs. This cost-effectiveness is a significant factor in its financial trajectory, making it an attractive option for both patients and healthcare systems[3].

Challenges and Opportunities

Despite the positive market dynamics, there are challenges and opportunities that influence the financial trajectory of nitrofurantoin.

Resistance and Side Effects

While nitrofurantoin has a low resistance rate, there is an increasing concern about multi-drug resistant strains. This has led to a cautious approach in prescribing the drug, although it remains a viable option due to its targeted activity in the urinary tract. Side effects, such as peripheral neuropathy and pseudomembranous colitis, though rare, need to be monitored and managed[1][2].

Long-Term Prophylaxis

The efficacy and safety profile of macrocrystalline nitrofurantoin in long-term prophylaxis for recurrent UTIs present a significant opportunity. Studies have shown that long-term use of nitrofurantoin can significantly reduce the incidence of symptomatic episodes without leading to overgrowth of resistant bacteria or elimination of sensitive coliforms[5].

Key Players and Market Strategies

Several pharmaceutical companies are involved in the production and distribution of nitrofurantoin, including Procter & Gamble Pharmaceuticals and others.

Product Differentiation

Companies have focused on differentiating their products through formulations. For example, the Macrobid formulation, which combines macrocrystalline and monohydrate forms, offers a slower and more sustained release of the drug, improving patient compliance and reducing side effects[2].

Marketing and Distribution

Effective marketing and distribution strategies have played a crucial role in the drug's financial success. Companies have targeted both healthcare providers and patients, highlighting the benefits of nitrofurantoin, such as its high efficacy, low resistance rates, and convenient dosing regimens.

Future Outlook

The future outlook for nitrofurantoin, particularly the macrocrystalline form, is promising.

Continued Regulatory Support

Regulatory bodies continue to support the use of nitrofurantoin as a first-line treatment for UTIs, which is expected to drive further market growth.

Research and Development

Ongoing research into new formulations and dosing regimens could further enhance the drug's efficacy and safety profile, potentially expanding its market share.

Global Expansion

As the drug gains more widespread acceptance globally, its market reach and financial performance are likely to improve.

Key Takeaways

• Increasing Demand: Nitrofurantoin's demand is rising due to its repositioning as a first-line therapy for UTIs.
• Regulatory Approvals: Recent regulatory approvals and reclassifications have made the drug more accessible.
• Competitive Advantage: The drug's low resistance rates and targeted activity give it a competitive edge.
• Financial Growth: Revenue has increased due to improved patient adherence and reduced treatment failures.
• Challenges and Opportunities: Monitoring resistance and side effects while exploring long-term prophylaxis opportunities.

FAQs

What is the primary use of nitrofurantoin?

Nitrofurantoin is primarily used to treat urinary tract infections (UTIs), particularly uncomplicated lower UTIs.

What are the different forms of nitrofurantoin available?

Nitrofurantoin is available in oral forms such as capsules, tablets, and suspension. The macrocrystalline form is particularly noted for its slower dissolution and absorption.

How does the macrocrystalline form of nitrofurantoin compare to the microcrystalline form?

The macrocrystalline form offers a higher cure rate and lower incidence of side effects compared to the microcrystalline form.

What are the common side effects of nitrofurantoin?

Common side effects include peripheral neuropathy, pseudomembranous colitis, and gastrointestinal issues. Rare but serious side effects include benign intracranial hypertension and psychotic reactions.

Is nitrofurantoin suitable for long-term use?

Yes, macrocrystalline nitrofurantoin is suitable for long-term prophylaxis of recurrent UTIs, with a favorable safety and efficacy profile over 12 months.

Sources

1. Frontiers in Cellular and Infection Microbiology: "Nitrofurantoin: properties and potential in treatment of urinary tract infections"[1]
2. FDA Label: "Macrobid (Nitrofurantoin Capsules, USP) (monohydrate/macrocrystals)"[2]
3. Medsafe New Zealand: "Application to widen the classification of MACROBID 100mg Capsules"[3]
4. NCBI Bookshelf: "Nitrofurantoin - Pharmaceutical Drugs"[4]
5. PubMed: "Efficacy and safety profile of long-term nitrofurantoin in urinary infections"[5]