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Last Updated: December 22, 2024

LEVAMISOLE HYDROCHLORIDE - Generic Drug Details


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

Levamisole hydrochloride is the generic ingredient in one branded drug marketed by Janssen Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for levamisole hydrochloride.

Summary for LEVAMISOLE HYDROCHLORIDE
Recent Clinical Trials for LEVAMISOLE HYDROCHLORIDE

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

SponsorPhase
LinkDoc Technology (Beijing) Co. Ltd.Phase 4
Jianhua ZhouPhase 4
Programme National de Lutte contre l'Onchocercose, Republic of the CongoPhase 2

See all LEVAMISOLE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for LEVAMISOLE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for LEVAMISOLE HYDROCHLORIDE

US Patents and Regulatory Information for LEVAMISOLE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharma ERGAMISOL levamisole hydrochloride TABLET;ORAL 020035-001 Jun 18, 1990 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

LEVAMISOLE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Levamisole Hydrochloride

Market Overview

The Levamisole Hydrochloride market is characterized by a complex interplay between the pharmaceutical and veterinary sectors. Initially developed as an anthelmintic, Levamisole HCl is primarily used in veterinary medicine to treat parasitic infections in livestock such as cattle, sheep, and pigs. Additionally, it has gained attention in the pharmaceutical sector for its off-label use in treating colorectal cancer due to its immunomodulatory effects[1].

Key Market Drivers

Increased Livestock Population and Rising Demand for Animal Health Products

The livestock industry, particularly in regions like Asia-Pacific and Latin America, has experienced robust growth. This increase in livestock population has heightened the risk of parasitic infections, driving the demand for antiparasitic agents like Levamisole HCl. The use of Levamisole HCl in livestock ensures animal health and prevents parasitic infections from compromising the food supply chain, significantly contributing to market demand[1].

Applications in Cancer Immunotherapy

Levamisole HCl's immunomodulatory properties have made it a candidate for cancer immunotherapy, particularly in treating colorectal cancer. This application has expanded its market scope beyond veterinary medicine, attracting interest from pharmaceutical companies and researchers[1].

Rising Veterinary Expenditures

With a heightened focus on improving animal welfare, especially in developed countries, veterinary care has become a priority. This trend, supported by increasing pet ownership and investments in livestock health, has positively influenced the Levamisole HCl market[1].

Market Segmentation

The Levamisole HCl market is segmented based on its application, distribution channel, and regional markets.

Application Areas

  • Veterinary Medicine: The primary use of Levamisole HCl is in treating parasitic infections in livestock.
  • Human Pharmaceuticals: It is used off-label in cancer treatment, particularly for colorectal cancer.
  • Agricultural Sector: It plays a role in ensuring the health of agricultural animals[1].

Distribution Channels

  • Direct Sales: To hospitals, clinics, and veterinary pharmacies.
  • Online and Retail Pharmacies: Providing convenient access to the drug[1].

Regional Markets

  • North America: Holds a significant share due to advanced veterinary care infrastructure and demand for cancer immunotherapy.
  • Europe: Benefits from a robust pharmaceutical sector and increasing cancer immunotherapy applications.
  • Asia-Pacific: Driven by the growing livestock industry and high prevalence of parasitic infections[1].

Challenges and Restraints

Despite its promising applications, the Levamisole HCl market faces several challenges.

Competition from Alternative Drugs

Other antiparasitic drugs like albendazole and ivermectin offer alternative treatments, competing with Levamisole HCl in both human and veterinary medicine[1].

Safety Concerns

Levamisole HCl is associated with serious side effects, such as agranulocytosis, a condition where the number of white blood cells drops dangerously low. These safety concerns have led to restrictions on its use in some markets, limiting its potential[1].

Financial Trajectory

Current Market Size and Growth

The Levamisole HCl market has shown impressive growth, driven by the increasing demand in both veterinary and pharmaceutical sectors. While specific financial figures for the Levamisole HCl market are not provided, the broader context indicates a growing market. For instance, the Limescale Preventer Market, which is not directly related but indicative of broader trends, is expected to grow from $1.67 billion in 2024 to $2.5 billion by 2032, with a CAGR of around 5.16% during the forecast period[1].

Future Opportunities and Trends

The market is expected to expand as the agricultural and pharmaceutical sectors continue to grow. Key trends include:

  • Development of New Formulations: Efforts to develop new formulations that reduce side effects are underway.
  • Increasing Research in Cancer Treatment: Ongoing research into its applications in cancer treatment is expected to drive growth.
  • Emerging Markets: There is potential for growth in emerging markets, particularly in Africa and South Asia, where parasitic infections remain widespread and healthcare infrastructure is improving[1].

Regional Performance

North America

North America holds a significant share of the market due to its advanced veterinary care infrastructure and the demand for cancer immunotherapy. The region's robust pharmaceutical sector also contributes to its market dominance[1].

Europe

Europe benefits from a strong pharmaceutical sector and increasing applications in cancer immunotherapy. The region's emphasis on animal welfare and advanced veterinary care also supports the market[1].

Asia-Pacific

The Asia-Pacific region is driven by the growing livestock industry and the high prevalence of parasitic infections. This region is expected to see substantial growth as the demand for animal health products increases[1].

Key Players and Market Competition

The Levamisole HCl market is dominated by pharmaceutical companies based in regions such as North America, Europe, and Asia-Pacific. These companies are involved in the production and distribution of Levamisole HCl, and they play a crucial role in driving market growth through innovation and expansion into new markets[1].

Safety and Efficacy Studies

Recent studies have highlighted the safety and efficacy of Levamisole HCl in various applications. For instance, a study on the use of Levamisole in treating Loiasis showed that a single 2.5mg/kg dose induces a promising transient reduction in Loa loa microfilarial densities, encouraging further testing of different regimens[2].

Adulteration in Cocaine

Levamisole has also been identified as a common adulterant in cocaine, leading to serious health complications such as agranulocytosis, vasculitis, and leukoencephalopathy. This illicit use has significant medical and legal implications but does not directly impact the legitimate market dynamics of Levamisole HCl[4].

Key Takeaways

  • Growing Demand: The Levamisole HCl market is driven by increasing demand in veterinary and pharmaceutical sectors.
  • Regional Growth: North America, Europe, and Asia-Pacific are key regions driving market growth.
  • Challenges: The market faces challenges from alternative drugs and safety concerns.
  • Future Trends: Development of new formulations and increasing research in cancer treatment are expected to drive future growth.
  • Emerging Markets: Potential for growth in Africa and South Asia due to improving healthcare infrastructure.

FAQs

Q: What are the primary applications of Levamisole HCl? A: Levamisole HCl is primarily used in veterinary medicine to treat parasitic infections in livestock and has off-label use in treating colorectal cancer in humans.

Q: Which regions are driving the growth of the Levamisole HCl market? A: North America, Europe, and Asia-Pacific are the key regions driving the growth of the Levamisole HCl market.

Q: What are the major challenges facing the Levamisole HCl market? A: The market faces challenges from alternative antiparasitic drugs and safety concerns related to serious side effects.

Q: Is Levamisole HCl used in any other contexts? A: Yes, it has been used as an adulterant in cocaine, leading to serious health complications, but this does not impact its legitimate market dynamics.

Q: What are the future trends expected in the Levamisole HCl market? A: Future trends include the development of new formulations to reduce side effects and increasing research into its applications in cancer treatment.

Cited Sources

  1. OpenPR: "Levamisole Hcl Market Showing Impressive Growth during Forecast by 2032"
  2. Oxford Academic: "Safety and Efficacy of Levamisole in Loiasis: A Randomized..."
  3. Ken Research: "Global Levamisole Hydrochloride Market: Ken Research"
  4. Science.gov: "Levamisole tainted cocaine: Topics by Science.gov"
  5. Market Research Intellect: "Levamisole Hydrochloride Tablets Market Size, Scope And Forecast..."

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