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Last Updated: March 18, 2025

Nitazoxanide - Generic Drug Details


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

Nitazoxanide is the generic ingredient in two branded drugs marketed by Romark, Rising, and Zenara, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nitazoxanide. Two suppliers are listed for this compound.

Summary for nitazoxanide
Drug Prices for nitazoxanide

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Recent Clinical Trials for nitazoxanide

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

SponsorPhase
Marwa Ahmed El-SamongyPhase 2/Phase 3
Anahuac UniversityN/A
Sadat City UniversityPhase 1/Phase 2

See all nitazoxanide clinical trials

Pharmacology for nitazoxanide
Drug ClassAntiprotozoal

US Patents and Regulatory Information for nitazoxanide

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rising NITAZOXANIDE nitazoxanide TABLET;ORAL 213820-001 Nov 27, 2020 AB RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zenara NITAZOXANIDE nitazoxanide TABLET;ORAL 214844-001 Feb 3, 2025 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for nitazoxanide

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide FOR SUSPENSION;ORAL 021498-001 Nov 22, 2002 ⤷  Try for Free ⤷  Try for Free
Romark ALINIA nitazoxanide TABLET;ORAL 021497-001 Jul 21, 2004 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory of Nitazoxanide

Introduction to Nitazoxanide

Nitazoxanide, sold under brand names such as Alinia, is a broad-spectrum antiparasitic and antiviral medication. It is used to treat various helminthic, protozoal, and viral infections, including those caused by Cryptosporidium parvum and Giardia lamblia[2].

Market Size and Growth

The global nitazoxanide market has been experiencing significant growth, driven by increasing demand for effective treatments against parasitic and viral infections. As of 2023, the global nitazoxanide market size was substantial, with a compound annual growth rate (CAGR) projected to be notable from 2024 to 2031[1].

Market Segmentation

The nitazoxanide market is segmented based on type and application. The Type I segment accounted for a noticeable share of the global market in 2023 and is expected to continue growing significantly in the near future. The Application 1 segment is also anticipated to expand at a significant CAGR throughout the forecast period[1].

Regional Analysis

The market is analyzed across various regions, including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Each region has its own market size and growth dynamics, influenced by local healthcare needs, regulatory environments, and economic conditions[1].

Key Players and Strategies

Companies such as Pure Chemistry Scientific and BOC Sciences are key players in the nitazoxanide market. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business globally. Their strategies include technological advancements, market expansion, and competitive pricing[1].

Market Drivers

Several factors drive the growth of the nitazoxanide market:

  • Increasing Prevalence of Parasitic and Viral Infections: The rising incidence of infections such as cryptosporidiosis and giardiasis, particularly in immunocompromised individuals, drives the demand for effective treatments like nitazoxanide[2].
  • Technological Advancements: Continuous research and development in the pharmaceutical sector, including the exploration of nitazoxanide's antiviral properties, contribute to market growth[2][5].
  • Expanding Applications: Nitazoxanide's efficacy in treating a range of infections, including influenza, chronic hepatitis B, and COVID-19, expands its market potential[2][5].

Market Restraints

Despite the growth drivers, there are several restraints to consider:

  • Regulatory Challenges: The approval process for new indications and the stringent regulatory environment can slow market growth[2].
  • Side Effects and Safety Concerns: Although generally well-tolerated, nitazoxanide can have adverse effects, which may impact its adoption in certain patient groups[5].
  • Competition from Alternative Treatments: The presence of other antiparasitic and antiviral drugs can compete with nitazoxanide for market share[5].

Financial Trajectory

The financial trajectory of the nitazoxanide market is promising, with significant revenue growth expected over the forecast period. Here are some key financial indicators:

  • Revenue Growth: The market is projected to grow substantially from 2024 to 2031, driven by increasing demand and expanding applications[1][4].
  • CAGR: The compound annual growth rate is expected to be notable, reflecting the market's robust growth potential[1].
  • Market Size by Region: Each region is expected to contribute significantly to the overall market size, with varying growth rates based on local market dynamics[1].

Competitive Analysis

The competitive landscape of the nitazoxanide market is characterized by a few key players who dominate the market. These companies compete based on product quality, pricing, and market reach. The competitive analysis includes:

  • Market Share: Key players like Pure Chemistry Scientific and BOC Sciences hold significant market shares, with ongoing efforts to increase their market presence[1].
  • Product Differentiation: Companies focus on differentiating their products through innovative formulations and expanded indications[1].

Technological Trends

Technological advancements play a crucial role in the nitazoxanide market:

  • Research and Development: Ongoing research into new applications, such as the treatment of colorectal cancer and breast cancer, and its antiviral properties against influenza and COVID-19, drives market innovation[2][3].
  • Manufacturing Process Improvements: Technological advancements in the production of high-quality chemicals are essential for maintaining market competitiveness[1].

Consumer Behavior Analysis

Consumer behavior analysis is critical for understanding market dynamics:

  • Patient Preferences: Patients and healthcare providers increasingly prefer treatments with broad-spectrum efficacy and minimal side effects, which favors nitazoxanide[5].
  • Healthcare Policies: Changes in healthcare policies and reimbursement strategies can influence the adoption of nitazoxanide in different regions[1].

SWOT Analysis

A SWOT analysis provides a comprehensive view of the market's strengths, weaknesses, opportunities, and threats:

  • Strengths: Broad-spectrum efficacy, expanding applications, and strong research backing.
  • Weaknesses: Regulatory challenges, potential side effects, and competition from other treatments.
  • Opportunities: Growing demand for antiparasitic and antiviral treatments, technological advancements.
  • Threats: Economic downturns, changes in regulatory environments, and emergence of new competitors[1].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on the nitazoxanide market:

  • Increased Demand: The pandemic has accelerated research into antiviral treatments, including nitazoxanide, for COVID-19[2].
  • Supply Chain Disruptions: Global supply chain disruptions have affected the production and distribution of nitazoxanide, though this impact is expected to be temporary[1].

Future Market Opportunities

The future of the nitazoxanide market looks promising with several opportunities:

  • Expanding Indications: Ongoing research into new applications, such as chronic hepatitis B and C, and other viral infections, will expand the market[2][5].
  • Emerging Markets: Growing healthcare needs in emerging economies offer significant market opportunities for nitazoxanide[1].

Key Takeaways

  • The global nitazoxanide market is expected to grow significantly from 2024 to 2031.
  • The market is driven by increasing demand for effective treatments against parasitic and viral infections.
  • Key players are focusing on technological advancements and market expansion.
  • Regulatory challenges and competition from alternative treatments are key restraints.
  • The market has significant growth potential, especially in emerging economies.

FAQs

Q: What are the primary applications of nitazoxanide? A: Nitazoxanide is primarily used to treat infections caused by Cryptosporidium parvum and Giardia lamblia, as well as other protozoal and helminthic infections. It is also being researched for its antiviral properties against influenza, COVID-19, and other viral infections[2].

Q: Who are the key players in the nitazoxanide market? A: Key players include Pure Chemistry Scientific and BOC Sciences, among others. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business globally[1].

Q: What are the major drivers of the nitazoxanide market? A: The market is driven by the increasing prevalence of parasitic and viral infections, technological advancements, and the expanding applications of nitazoxanide[2][5].

Q: How has the COVID-19 pandemic impacted the nitazoxanide market? A: The pandemic has accelerated research into antiviral treatments, including nitazoxanide, and has highlighted the importance of broad-spectrum antiviral drugs. However, it has also caused temporary supply chain disruptions[1][2].

Q: What are the potential future market opportunities for nitazoxanide? A: Future opportunities include expanding indications into new areas such as chronic hepatitis B and C, and growing healthcare needs in emerging economies[1][2].

Sources

  1. Cognitive Market Research: Nitazoxanide Market Report 2024 (Global Edition)
  2. Wikipedia: Nitazoxanide
  3. NCBI: Investigations of nitazoxanide molecular targets and pathways for ...
  4. Verified Market Research: Alinia (Nitazoxanide) Market Size And Forecast
  5. DrugBank: Nitazoxanide: Uses, Interactions, Mechanism of Action - DrugBank

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