Nitrofurantoin - Generic Drug Details

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

Nitrofurantoin is the generic ingredient in eight branded drugs marketed by Watson Labs, Casper Pharma Llc, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Carnegie, Nostrum Labs Inc, Novel Labs Inc, Novitium Pharma, Procter And Gamble, Chartwell Molecular, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Sun Pharm Industries, Zydus Pharms, Alvogen, Chartwell Rx, Inventia, Micro Labs, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for nitrofurantoin. Twelve suppliers are listed for this compound.

Summary for nitrofurantoin

US Patents:	0
Tradenames:	8
Applicants:	31
NDAs:	46
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	54
Patent Applications:	6,496
Drug Prices:	Drug price trends for nitrofurantoin
What excipients (inactive ingredients) are in nitrofurantoin?	nitrofurantoin excipients list
DailyMed Link:	nitrofurantoin at DailyMed

See drug prices for nitrofurantoin

See drug sales revenues for nitrofurantoin

Recent Clinical Trials for nitrofurantoin

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

Sponsor	Phase
University of Minnesota	Early Phase 1
Walter Reed National Military Medical Center	Phase 2
Goodlife Pharma B.V.	Phase 4

See all nitrofurantoin clinical trials

Pharmacology for nitrofurantoin

Drug Class

Nitrofuran Antibacterial

Medical Subject Heading (MeSH) Categories for nitrofurantoin

Anti-Infective Agents, Urinary

Anatomical Therapeutic Chemical (ATC) Classes for nitrofurantoin

J01XE	Nitrofuran derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for nitrofurantoin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Molecular	FURALAN	nitrofurantoin	TABLET;ORAL	080017-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sunny	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	208516-001	May 24, 2018	AB	RX	No	No
Chartwell Rx	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076648-001	Mar 22, 2004		DISCN	No	No
Ranbaxy Labs Ltd	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076951-001	Mar 30, 2005		DISCN	No	No
Chartwell Molecular	FURALAN	nitrofurantoin	TABLET;ORAL	080017-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175-002	Jun 9, 2023		RX	Yes	Yes

Nitrofurantoin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nitrofurantoin

Introduction

Nitrofurantoin, an antibiotic used to treat urinary tract infections (UTIs), is a significant player in the pharmaceutical market. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global nitrofurantoin market is expected to exhibit steady growth over the forecast period. As of 2023, the market size was valued at approximately USD 623 million, and it is projected to grow to USD 871 million by 2032, at a compound annual growth rate (CAGR) of around 4-5%[4].

Drivers of Growth

Several factors drive the growth of the nitrofurantoin market:

Increasing Prevalence of UTIs

The rising incidence of UTIs, particularly among women, is a significant driver. The UTI treatment market, which includes nitrofurantoin, is projected to grow from $10.12 billion in 2023 to $11.74 billion by 2028, with a CAGR of 2.9%[3].

Advancements in Antibiotics

Advancements in antibiotic formulations and the development of new treatment protocols contribute to market growth. The widespread use of urinary catheters and adherence to clinical guidelines also support the demand for nitrofurantoin[3].

Regional Dynamics

North America currently dominates the UTI treatment market, including nitrofurantoin, due to high healthcare spending and advanced medical infrastructure. However, the Asia-Pacific region is expected to exhibit the fastest growth during the forecast period, driven by increasing healthcare awareness and improving economic conditions[3].

Market Segmentation

The nitrofurantoin market can be segmented in several ways:

By Type

Nitrofurantoin is available in various forms, including capsules and suspensions. The capsule form is more commonly used and accounts for a larger share of the market[5].

By Application

Nitrofurantoin is primarily used to treat uncomplicated and complicated UTIs. The uncomplicated UTI segment is the largest due to the higher incidence of such infections[3].

By Distribution Channel

The drug is distributed through various channels, including hospital pharmacies, gynecology and urology clinics, drug stores, retail pharmacies, and online drug stores. Hospital pharmacies and retail pharmacies are the major distribution channels[3].

Competitive Landscape

The nitrofurantoin market is competitive, with several key players involved in its production and distribution. Companies such as Pfizer and other generic manufacturers compete based on factors like pricing, product quality, and distribution networks[1].

Challenges and Restraints

Despite the growth potential, the nitrofurantoin market faces several challenges:

Antibiotic Resistance

The rise in antibiotic-resistant bacterial strains is a significant concern. This has led to the development of non-antibiotic treatment options and alternative therapies, which could impact the demand for nitrofurantoin[3].

Side Effects and Safety Concerns

Nitrofurantoin can cause various side effects, including lung problems, liver issues, and peripheral neuropathy. These safety concerns can affect patient compliance and overall market demand[5].

Regulatory Environment

Stringent regulatory requirements and the need for continuous monitoring of drug safety can also pose challenges for manufacturers and impact the market's financial trajectory[5].

Technological Trends

The market is witnessing several technological trends that could influence its future:

Microbiome-Based Therapies

Research into microbiome-based therapies offers potential alternatives to traditional antibiotics like nitrofurantoin. This could reshape the UTI treatment landscape in the coming years[3].

Telemedicine and Remote Consultations

The integration of telemedicine and remote consultations is expected to enhance patient access to UTI treatments, including nitrofurantoin, especially in underserved areas[3].

Financial Projections

The financial trajectory of the nitrofurantoin market is positive, with steady growth anticipated over the next decade. Here are some key financial projections:

• Market Size: Expected to grow from USD 623 million in 2023 to USD 871 million by 2032[4].
• CAGR: Around 4-5% during the forecast period[4].
• Revenue Share: The uncomplicated UTI segment is expected to maintain its dominance, contributing significantly to the overall revenue[3].

Regional Analysis

The regional dynamics of the nitrofurantoin market are crucial for understanding its financial trajectory:

• North America: Currently the largest market, driven by high healthcare spending and advanced medical infrastructure[3].
• Asia-Pacific: Expected to be the fastest-growing region, driven by increasing healthcare awareness and economic growth[3].

Key Takeaways

• The nitrofurantoin market is expected to grow steadily, driven by the increasing prevalence of UTIs and advancements in antibiotics.
• The market faces challenges such as antibiotic resistance and safety concerns.
• Technological trends like microbiome-based therapies and telemedicine are expected to influence the market.
• North America is the current leader, but the Asia-Pacific region is anticipated to show the fastest growth.

FAQs

What is the primary use of nitrofurantoin?

Nitrofurantoin is primarily used to treat urinary tract infections (UTIs), including both uncomplicated and complicated cases[5].

What are the common side effects of nitrofurantoin?

Common side effects include diarrhea, gas, and in some cases, severe lung problems, liver issues, and peripheral neuropathy[5].

Which region is expected to dominate the nitrofurantoin market in the future?

The Asia-Pacific region is expected to exhibit the fastest growth during the forecast period, driven by increasing healthcare awareness and economic growth[3].

What are the key drivers of the nitrofurantoin market?

Key drivers include the increasing prevalence of UTIs, advancements in antibiotics, and the widespread use of urinary catheters[3].

How is the nitrofurantoin market segmented?

The market is segmented by type (capsules and suspensions), application (uncomplicated and complicated UTIs), and distribution channel (hospital pharmacies, retail pharmacies, etc.)[3].

Sources:

1. Global Nitrofurantoin Market Report 2024 Edition - Cognitivemarketresearch.com
2. Pseudotumor and Nitrofurantoin Therapy - JAMA Network
3. Urinary Tract Infection Treatment Market Set to Expand - EINPresswire.com
4. Nitrofurantoin API Market Research Report 2032 - Dataintelo.com
5. Nitrofurantoin (oral route) - Mayo Clinic