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Last Updated: December 23, 2024

NICLOSAMIDE - Generic Drug Details


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

Niclosamide is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for niclosamide.

Summary for NICLOSAMIDE
Recent Clinical Trials for NICLOSAMIDE

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

SponsorPhase
Stanford UniversityPhase 1
TFF Pharmaceuticals, Inc.Phase 1
The University of Western AustraliaPhase 4

See all NICLOSAMIDE clinical trials

Medical Subject Heading (MeSH) Categories for NICLOSAMIDE

US Patents and Regulatory Information for NICLOSAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms NICLOCIDE niclosamide TABLET, CHEWABLE;ORAL 018669-001 May 14, 1982 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

NICLOSAMIDE Market Analysis and Financial Projection Experimental

Niclosamide: Market Dynamics and Financial Trajectory

Introduction

Niclosamide, a salicylanilide introduced in the 1960s as an oral treatment for tapeworm infections, has evolved to become a versatile therapeutic agent with broad-spectrum anti-infective properties. This article delves into the market dynamics and financial trajectory of niclosamide, highlighting its current and potential applications, market growth drivers, and financial implications.

Historical Context and Current Use

Niclosamide was initially approved by the FDA as an oral anthelmintic drug for treating tapeworm infections. Over the years, its biological activity has been found to extend beyond parasitic infections, including anticancer, antibacterial, and antiviral properties[3][4].

Market Growth Drivers

The niclosamide market is driven by several key factors:

Increasing Healthcare Needs

The global increase in awareness about parasitic diseases and the growing emphasis on improving public health, especially in developing regions, have led to a rise in demand for effective treatments like niclosamide piperazine salt. This demand is further fueled by increased healthcare spending and investments in pharmaceutical research[1].

Expanding Therapeutic Applications

Research on niclosamide's potential antiviral and anticancer properties is expanding its use beyond traditional parasitic infections. Its efficacy against SARS-CoV-2 and other respiratory infections has sparked significant interest among researchers and healthcare providers[3][4].

Technological Advancements

Advancements in drug development and formulation technologies are expected to expand the applications of niclosamide, driving steady market growth. New formulations and analogs of niclosamide are being developed to improve its potency and reduce cytotoxicity[3].

Mergers and Acquisitions

The niclosamide market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness. These strategic consolidations provide access to new technologies, intellectual property, and talent, enabling companies to innovate faster[1].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is a rapidly growing market for niclosamide, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region contribute to greater demand for niclosamide products and services[1].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries like the United Kingdom, Germany, France, and Italy are key players in this market[1].

Latin America

Latin America presents both opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players. Economic fluctuations and political instability in some countries can impact market dynamics and consumer behavior[1].

Middle East and Africa

These regions also offer significant potential due to the prevalence of parasitic infections and the need for effective treatments. Government and private investments in healthcare infrastructure are driving the demand for niclosamide in these areas[1].

Financial Trajectory

Market Size and Growth

The niclosamide piperazine salt market is anticipated to witness a compound annual growth rate (CAGR) of 12.29% from 2024 to 2031. The market is expected to grow from USD 2.85 billion in 2024 to USD 6.41 billion by 2031[1].

Key Players and Investments

Companies like Luosen Auxiliaries, Shanghai Xinchen Chemical, Hangzhou Keying Chem, Hengcheng Pharmaceutical Group, and Hubei Bolan Chemical are significant players in the niclosamide market. These companies are investing heavily in research and development to expand the therapeutic applications of niclosamide[1].

Strategic Shifts in Biopharma

First Wave BioPharma's decision to divest its Niclosamide program and focus on late-stage clinical programs is a strategic move that could enhance the company's financial position. The transaction includes an upfront payment and future milestone payments and royalties, providing a non-dilutive capital infusion[2].

Challenges and Opportunities

Liability and Efficacy

Niclosamide's low selectivity index in certain cell lines represents a liability for therapeutic use. However, research on its analogs and structure-activity relationships suggests potential for designing better niclosamide analogs with improved properties[3].

Regulatory and Market Approval

The success of niclosamide in new therapeutic areas depends on regulatory approvals and market acceptance. Companies must navigate through stringent regulatory processes to ensure the safe and effective use of niclosamide in various applications[2].

Environmental and Sustainability Concerns

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives. The demand for eco-friendly niclosamide products and services is on the rise, presenting both opportunities and challenges for manufacturers[1].

Future Outlook

Emerging Applications

The potential of niclosamide in treating GI diseases, such as inflammatory bowel diseases (IBD), and its antiviral properties against SARS-CoV-2 and other respiratory infections, make it a promising therapeutic agent. Ongoing research and clinical trials are expected to expand its applications further[2][3].

Technological Innovations

Advancements in drug formulation technologies and the development of new analogs are likely to improve the efficacy and safety of niclosamide. These innovations will be crucial in addressing the current liabilities associated with niclosamide and in exploring new therapeutic areas[3].

Key Takeaways

  • Growing Market: The niclosamide market is expected to grow significantly, driven by increasing healthcare needs and expanding therapeutic applications.
  • Regional Dynamics: Asia-Pacific, Europe, and Latin America are key regions driving the market growth.
  • Financial Growth: The market is anticipated to reach USD 6.41 billion by 2031, with a CAGR of 12.29% from 2024 to 2031.
  • Strategic Shifts: Companies are making strategic moves to focus on late-stage clinical programs and expand their product portfolios.
  • Challenges and Opportunities: Addressing liabilities and regulatory hurdles while capitalizing on emerging applications and technological innovations.

FAQs

What are the primary uses of niclosamide?

Niclosamide is primarily used as an oral anthelmintic drug for treating tapeworm infections but is also being researched for its antiviral, antibacterial, and anticancer properties.

Which regions are driving the growth of the niclosamide market?

The Asia-Pacific region, Europe, and Latin America are key drivers of the niclosamide market growth.

What is the expected CAGR of the niclosamide piperazine salt market from 2024 to 2031?

The niclosamide piperazine salt market is anticipated to witness a CAGR of 12.29% from 2024 to 2031.

Why is First Wave BioPharma divesting its Niclosamide program?

First Wave BioPharma is divesting its Niclosamide program to focus on late-stage clinical programs and to secure non-dilutive capital through upfront payments and future milestone payments and royalties.

What are the potential liabilities of niclosamide in therapeutic use?

Niclosamide has a low selectivity index in certain cell lines, which represents a liability for therapeutic use. However, research on its analogs is aimed at improving its properties.

Sources

  1. OpenPR: Niclosamide Piperazine Salt Market Size, Share and Forecast[1].
  2. StockTitan: First Wave BioPharma Announces Streamlining of Clinical Pipeline[2].
  3. MDPI: In Vitro Evaluation and Mitigation of Niclosamide's Liabilities[3].
  4. UNION Therapeutics: Niclosamide[4].

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