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Last Updated: December 22, 2024

NITROFURANTOIN MACROCRYSTALLINE Drug Patent Profile


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

Nitrofurantoin Macrocrystalline is a drug marketed by Watson Labs and is included in two NDAs.

The generic ingredient in NITROFURANTOIN MACROCRYSTALLINE is nitrofurantoin, macrocrystalline. Twenty-eight suppliers are listed for this compound. Additional details are available on the nitrofurantoin, macrocrystalline profile page.

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SponsorPhase
MJM BontenPhase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
SaltroPhase 3

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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
Watson Labs NITROFURANTOIN MACROCRYSTALLINE nitrofurantoin, macrocrystalline CAPSULE;ORAL 070248-001 Jun 24, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs NITROFURANTOIN MACROCRYSTALLINE nitrofurantoin, macrocrystalline CAPSULE;ORAL 070249-001 Jun 24, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NITROFURANTOIN MACROCRYSTALLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nitrofurantoin Macrocrystals

Introduction

Nitrofurantoin macrocrystals, a formulation of the antibiotic nitrofurantoin, have been a staple in the treatment and prophylaxis of urinary tract infections (UTIs) for decades. This article delves into the market dynamics and financial trajectory of this drug, highlighting its efficacy, market trends, and financial performance.

Efficacy and Safety Profile

Nitrofurantoin macrocrystals have demonstrated a strong efficacy and safety profile, particularly in the long-term prophylaxis of recurrent UTIs. Studies have shown that macrocrystalline nitrofurantoin reduces the incidence of symptomatic UTI episodes significantly, with a 5.4-fold decrease during prophylaxis[2].

Market Segmentation

The market for nitrofurantoin macrocrystals can be segmented based on several factors:

Geographical Segmentation

The global market for nitrofurantoin macrocrystals is diverse, with different regions having varying demand and regulatory environments. For instance, in New Zealand, the modified release formulation of nitrofurantoin (Macrobid) gained regulatory approval in 2020, which has impacted local market dynamics[5].

Product Formulation

The market is segmented into different formulations, including macrocrystalline and microcrystalline forms. Macrocrystalline formulations have largely replaced microcrystalline ones due to their slower dissolution and absorption rates, which reduce gastrointestinal side effects[5].

Therapeutic Use

Nitrofurantoin macrocrystals are used for both the treatment and prophylaxis of UTIs. The treatment segment includes acute uncomplicated UTIs, while the prophylaxis segment focuses on preventing recurrent infections[2][4].

Market Trends

Increasing Demand for Effective UTI Treatments

The rising incidence of UTIs and the growing resistance to other antibiotics have increased the demand for nitrofurantoin macrocrystals. This trend is expected to continue as healthcare providers seek effective and safe treatment options[3].

Advancements in Formulations

The introduction of modified release formulations like Macrobid has enhanced patient compliance and reduced treatment failures. These formulations require less frequent dosing, making them more convenient for patients[5].

Regulatory Approvals and Funding

Recent regulatory approvals and funding for modified release nitrofurantoin in various countries have expanded market access and increased the drug's visibility among healthcare providers and patients[5].

Financial Performance

Market Size and Growth

The global nitrofurantoin macrocrystals market is expected to grow, driven by increasing demand and the introduction of new formulations. Market research reports indicate a significant market size, with the global market valued at several million dollars and projected to grow over the next few years[1].

Pricing and Revenue

The pricing of nitrofurantoin macrocrystals varies based on the formulation and geographical location. For example, the Macrobid formulation is fully funded in New Zealand, which has positively impacted its revenue. The standard dose of nitrofurantoin can range from $50 to $100 mg per dose, contributing to substantial revenue for pharmaceutical companies[5].

Competitive Landscape

The market for nitrofurantoin macrocrystals is competitive, with several pharmaceutical companies offering different formulations. The competitive landscape is influenced by factors such as efficacy, safety profile, and patient compliance. Companies that offer convenient and effective formulations, like Macrobid, have a competitive edge[5].

Key Players and Market Share

Major pharmaceutical companies involved in the production and distribution of nitrofurantoin macrocrystals include those that manufacture Macrobid and Macrodantin. These companies hold significant market share due to their established brands and regulatory approvals[4].

Challenges and Opportunities

Antimicrobial Resistance

One of the significant challenges facing the nitrofurantoin macrocrystals market is the growing concern of antimicrobial resistance. However, nitrofurantoin's unique mechanism of action and lower resistance rates compared to other antibiotics present an opportunity for continued market growth[3].

Regulatory Environment

Changes in regulatory environments can significantly impact the market. For instance, the reclassification of nitrofurantoin to allow supply without prescription in certain countries can expand market access and increase revenue[5].

Patient Compliance and Adherence

Patient compliance is a crucial factor in the success of any treatment regimen. The introduction of modified release formulations like Macrobid, which require twice-daily dosing instead of four times daily, has improved patient adherence and reduced treatment failures[5].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of nitrofurantoin macrocrystals is essential for optimizing treatment regimens. The drug's slow release and absorption characteristics contribute to its efficacy and safety profile[3][4].

Clinical Evidence and Studies

Numerous clinical studies have supported the use of nitrofurantoin macrocrystals for UTI treatment and prophylaxis. These studies have demonstrated the drug's effectiveness in reducing symptomatic episodes and its favorable safety profile[2][5].

Future Outlook

The future outlook for nitrofurantoin macrocrystals is positive, driven by increasing demand, advancements in formulations, and favorable regulatory environments. As the healthcare industry continues to seek effective and safe treatment options for UTIs, the market for nitrofurantoin macrocrystals is expected to grow.

Key Takeaways

  • Efficacy and Safety: Nitrofurantoin macrocrystals have a strong efficacy and safety profile, particularly in long-term UTI prophylaxis.
  • Market Trends: Increasing demand for effective UTI treatments, advancements in formulations, and favorable regulatory approvals are driving market growth.
  • Financial Performance: The global market is valued at several million dollars and is projected to grow, with significant revenue generated from various formulations.
  • Competitive Landscape: The market is competitive, with major pharmaceutical companies holding significant market share.
  • Challenges and Opportunities: Antimicrobial resistance is a challenge, but nitrofurantoin's unique mechanism and lower resistance rates present opportunities.

FAQs

Q: What is the primary use of nitrofurantoin macrocrystals?

A: The primary use of nitrofurantoin macrocrystals is for the treatment and prophylaxis of urinary tract infections (UTIs).

Q: How do macrocrystalline and microcrystalline formulations differ?

A: Macrocrystalline formulations have slower dissolution and absorption rates compared to microcrystalline formulations, reducing gastrointestinal side effects.

Q: What is the impact of modified release formulations like Macrobid on patient compliance?

A: Modified release formulations like Macrobid improve patient compliance by requiring less frequent dosing, which reduces treatment failures.

Q: How does the regulatory environment affect the market for nitrofurantoin macrocrystals?

A: Regulatory approvals and funding for nitrofurantoin macrocrystals can expand market access and increase revenue.

Q: What are the key challenges facing the nitrofurantoin macrocrystals market?

A: The key challenges include antimicrobial resistance, although nitrofurantoin's unique mechanism of action and lower resistance rates mitigate this to some extent.

Sources

  1. Market Research Reports: Global Nitrofurantoin Macrocrystals Capsules Market Research Report 2024.
  2. PubMed: Efficacy and safety profile of long-term nitrofurantoin in urinary tract infections.
  3. Journal of Antimicrobial Chemotherapy: Review of the pharmacokinetic properties of nitrofurantoin and nitroxoline.
  4. FDA: Macrobid (Nitrofurantoin Capsules, USP) label.
  5. Medsafe New Zealand: Application to widen the classification of MACROBID 100mg Capsules.

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