NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details

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

Nitrofurantoin; nitrofurantoin, macrocrystalline is the generic ingredient in two branded drugs marketed by Almatica, Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-five suppliers are listed for this compound.

Summary for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	35
Clinical Trials:	3
DailyMed Link:	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE at DailyMed

Recent Clinical Trials for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

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

Sponsor	Phase
MJM Bonten	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	Phase 3

See all NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Drug Class

Nitrofuran Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN; 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; NITROFURANTOIN, MACROCRYSTALLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	209225-001	Mar 30, 2023	AB	RX	No	No
Chartwell Rx	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076648-001	Mar 22, 2004		DISCN	No	No
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	AB	RX	Yes	Yes
Mankind Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217357-001	Jul 11, 2023	AB	RX	No	No
Ranbaxy Labs Ltd	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076951-001	Mar 30, 2005		DISCN	No	No
Watson Labs Inc	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	202250-001	Jul 8, 2015	AB	RX	No	No

Expired US Patents for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

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

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nitrofurantoin and Nitrofurantoin Macrocrystals

Introduction

Nitrofurantoin, a widely used antibiotic, is a cornerstone in the treatment of uncomplicated urinary tract infections (UTIs). This article delves into the market dynamics, financial trajectory, and key factors influencing the nitrofurantoin and nitrofurantoin macrocrystals markets.

Market Size and Growth

The global nitrofurantoin market is expected to exhibit significant growth over the forecast period. As of 2024, the uncomplicated UTI market, which heavily relies on nitrofurantoin, is valued at approximately $7.2 billion and is projected to surpass $14.28 billion by 2031, growing at a CAGR of 10.23%[4].

Market Segmentation

By Type

The nitrofurantoin market is segmented into different types, including nitrofurantoin monohydrate and nitrofurantoin macrocrystals. Nitrofurantoin macrocrystals, such as those found in Macrobid capsules, account for a significant share due to their slower dissolution and absorption rates, which enhance their efficacy and reduce side effects[2].

By Treatment

The oral antibiotics segment, which includes nitrofurantoin, dominates the uncomplicated UTI therapeutics market. The ease of administration and better patient compliance of oral drugs compared to injectables drive this segment's growth[4].

By Pathogen Type

Escherichia coli (E. coli) is the most common cause of UTIs, and nitrofurantoin is highly effective against this pathogen. The E. coli segment is expected to dominate the market due to its prevalence in UTI cases[4].

By Region

North America is anticipated to hold a dominant position in the nitrofurantoin market over the forecast period, driven by advanced healthcare infrastructure and high disease awareness[4].

Key Drivers

Increasing Prevalence of UTIs

The rising prevalence of UTIs, particularly among women and the geriatric population, is a significant driver of the nitrofurantoin market. According to the World Health Organization (WHO), UTIs account for over 8.1 million doctor visits each year in the U.S. alone[4].

Antibiotic Resistance

The increasing antibiotic resistance among UTI-causing pathogens is pushing the demand for effective antibiotics like nitrofurantoin. This trend is expected to continue, driving market growth[4].

Market Restraints

Side Effects and Adverse Events

Nitrofurantoin can cause side effects such as peripheral neuropathy, pseudomembranous colitis, and other neurological issues. These adverse events can limit its use and impact market growth[2].

Limited Novel Therapies

The lack of novel antibiotics and the reliance on existing treatments like nitrofurantoin can lead to limited treatment options, potentially restraining market expansion[4].

Financial Trajectory

Revenue Forecast

The global nitrofurantoin market is expected to see substantial revenue growth. The uncomplicated UTI market, which is a significant segment for nitrofurantoin, is forecasted to grow from $7.2 billion in 2024 to $14.28 billion by 2031[4].

Competitive Landscape

Key players in the market, such as GlaxoSmithKline, Iterum Therapeutics, Fimbrion Therapeutics, Janssen Pharmaceuticals, and Immunotek, are focused on developing advanced treatment solutions to overcome antibiotic resistance. This competitive landscape drives innovation and market growth[4].

Efficacy and Safety Profile

Long-term Prophylaxis

Nitrofurantoin macrocrystals have been shown to be effective and safe for long-term prophylaxis of recurrent UTIs. A study involving 219 female patients demonstrated a significant reduction in symptomatic episodes during prophylaxis, with a favorable safety and tolerability profile[5].

Clinical Pharmacology

The unique formulation of Macrobid capsules, which contains both macrocrystalline and monohydrate forms of nitrofurantoin, ensures a sustained release of the drug, enhancing its efficacy and reducing side effects[2].

Regional Analysis

North America

North America is expected to dominate the nitrofurantoin market due to its advanced healthcare infrastructure and high disease awareness. The U.S. and Canada are key markets within this region[4].

Europe and Asia Pacific

Europe and the Asia Pacific region are also significant markets, with countries like Germany, the U.K., China, and India contributing to the growth of the nitrofurantoin market[4].

Technological Trends

Novel Therapeutics

The development of novel molecular-targeted therapies and combination therapies presents lucrative opportunities for the nitrofurantoin market. For instance, Genesys Therapeutics' caviurin, a host-targeting therapeutic candidate, is an example of innovative treatments being explored[4].

Market Attractiveness

SWOT Analysis

• Strengths: Effective against common UTI pathogens, long-term prophylaxis efficacy, and favorable safety profile.
• Weaknesses: Potential side effects, limited novel therapies.
• Opportunities: Increasing prevalence of UTIs, need for novel antibiotics.
• Threats: Antibiotic resistance, competition from new therapies[1].

Consumer Behavior Analysis

Patient Compliance

The ease of administration and better patient compliance with oral antibiotics like nitrofurantoin drive market growth. Patients prefer oral therapies due to their convenience and effectiveness[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the nitrofurantoin market. While there was an initial disruption in supply chains, the increased focus on healthcare and the rise in telemedicine have led to better access to treatments for UTIs, including nitrofurantoin[1].

Key Takeaways

• The global nitrofurantoin market is expected to grow significantly, driven by the increasing prevalence of UTIs and the need for effective antibiotics.
• Nitrofurantoin macrocrystals are a key segment due to their efficacy and favorable safety profile.
• North America is anticipated to dominate the market due to advanced healthcare infrastructure and high disease awareness.
• The development of novel therapies and combination treatments presents opportunities for market growth.
• Side effects and limited novel therapies are restraints that need to be addressed.

FAQs

What is the projected growth rate of the uncomplicated UTI market?

The uncomplicated UTI market is expected to grow at a CAGR of 10.23% from 2024 to 2031[4].

Which region is expected to dominate the nitrofurantoin market?

North America is expected to hold a dominant position in the nitrofurantoin market over the forecast period[4].

What are the key drivers of the nitrofurantoin market?

The increasing prevalence of UTIs and the need for effective antibiotics due to antibiotic resistance are key drivers of the nitrofurantoin market[4].

What are the potential side effects of nitrofurantoin?

Nitrofurantoin can cause side effects such as peripheral neuropathy, pseudomembranous colitis, and other neurological issues[2].

Is nitrofurantoin effective for long-term prophylaxis of UTIs?

Yes, nitrofurantoin macrocrystals have been shown to be effective and safe for long-term prophylaxis of recurrent UTIs[5].

Sources

1. Global Nitrofurantoin Market Report 2024 Edition - Cognitivemarketresearch.com
2. Macrobid (Nitrofurantoin Capsules, USP) Label - Accessdata.fda.gov
3. Global Nitrofurantoin Macrocrystals Capsules Market Research Report 2024 - Marketresearchreports.com
4. Uncomplicated Urinary Tract Infection Market Size to Hit USD 14.28 Billion by 2031 - Biospace.com
5. Efficacy and safety profile of long-term nitrofurantoin in urinary tract infections - PubMed.ncbi.nlm.nih.gov