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Last Updated: December 22, 2024

Chloroquine phosphate; primaquine phosphate - Generic Drug Details


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What are the generic sources for chloroquine phosphate; primaquine phosphate and what is the scope of patent protection?

Chloroquine phosphate; primaquine phosphate is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for chloroquine phosphate; primaquine phosphate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 18
DailyMed Link:chloroquine phosphate; primaquine phosphate at DailyMed
Recent Clinical Trials for chloroquine phosphate; primaquine phosphate

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

SponsorPhase
Pan American Health OrganizationPhase 2/Phase 3
University of California, San FranciscoPhase 2/Phase 3
Oswaldo Cruz FoundationPhase 2

See all chloroquine phosphate; primaquine phosphate clinical trials

US Patents and Regulatory Information for chloroquine phosphate; primaquine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE chloroquine phosphate; primaquine phosphate TABLET;ORAL 014860-002 Approved Prior to Jan 1, 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

Chloroquine phosphate; primaquine phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chloroquine Phosphate and Primaquine Phosphate

Introduction

Chloroquine phosphate and primaquine phosphate are two critical antimalarial drugs that have been pivotal in the global fight against malaria and other infectious diseases. This article delves into the market dynamics, financial trajectory, and key factors influencing these drugs.

Market Overview of Chloroquine Phosphate

Historical Context and Current Demand

Chloroquine phosphate, originally developed as an antimalarial drug, has seen a resurgence in interest due to its potential in treating autoimmune and inflammatory conditions. The drug's mechanism involves interfering with the growth and survival of malaria parasites and modulating the immune response, making it useful in conditions like rheumatoid arthritis and lupus[2].

Key Drivers

  • Persistent Malaria Prevalence: The ongoing prevalence of malaria, especially in tropical and subtropical regions, drives the demand for chloroquine phosphate. This is exacerbated by the growing resistance to conventional treatments, making chloroquine phosphate a vital component in malaria management[2].
  • COVID-19 Impact: The COVID-19 pandemic has significantly influenced the chloroquine phosphate market, with fluctuations in demand due to its initial exploration as a potential treatment for COVID-19, although this has been largely debunked[2].

Market Segmentation

  • Geographical Breakdown: The market is segmented into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. The Asia-Pacific region, where malaria is highly prevalent, drives a significant portion of the demand[2].
  • Application Segmentation: Chloroquine phosphate is used not only for malaria but also for autoimmune and inflammatory conditions, which expands its market scope[2].

Market Overview of Primaquine Phosphate

Historical Context and Current Demand

Primaquine phosphate, developed by Sanofi, is primarily used for the treatment of malaria caused by the Plasmodium vivax parasite. It has been approved globally since 1950 and is classified as an orphan drug due to its focus on a rare disease[4].

Key Drivers

  • Increasing Malaria Incidence: The rising incidence of malaria, particularly in tropical and subtropical regions, is a significant driver for the primaquine phosphate market. The World Health Organization (WHO) reports thousands of cases annually, necessitating effective treatments[3].
  • Government Initiatives and Funding: Technological advancements and government funding for malaria eradication efforts boost the demand for primaquine phosphate. Innovations in drug development processes and diagnostic technologies further enhance its market dynamics[3].

Market Segmentation

  • Disease Indication: The market is segmented by disease indication, including malaria, pneumocystis pneumonia (PCP), leprosy, and others. This segmentation helps in targeting the right healthcare practitioners and patients[3].
  • Geographical Segmentation: The market is categorized into regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. The Asia-Pacific region holds a large share due to the high prevalence of malaria[3].

Financial Trajectory

Revenue Projections

  • Chloroquine Phosphate: The market for chloroquine phosphate is expected to witness significant growth due to its diverse therapeutic applications. The demand driven by malaria and autoimmune diseases is projected to increase, although the exact revenue figures are influenced by various market dynamics and external factors such as the COVID-19 pandemic[2].
  • Primaquine Phosphate: The primaquine phosphate market is anticipated to grow substantially from 2023 to 2031, driven by the increasing incidence of malaria and advancements in drug development. The market size is expected to reach several billion USD by the end of the forecast period[1][3].

Cost and Pricing Analysis

  • Raw Material and Manufacturing Costs: The cost of setting up a manufacturing plant for both drugs involves significant capital investments, including raw material, machinery, and infrastructure costs. For chloroquine phosphate, the detailed process flow, utility requirements, and human resource needs are crucial in determining the overall cost structure[2].
  • Pricing Mechanism: The pricing of these drugs is influenced by market competition, regulatory frameworks, and the economic landscapes of different regions. The intense competition in the pharmaceutical industry, particularly from generics, can lead to pricing pressures and affect the revenue projections[3].

Competitive Landscape

Key Players

  • Chloroquine Phosphate: The market for chloroquine phosphate includes key players such as Pfizer, Novartis AG, and F. Hoffmann-La Roche Ltd, among others. These companies are involved in various market-related activities including partnerships, mergers and acquisitions, and product launches[2][3].
  • Primaquine Phosphate: Major players in the primaquine phosphate market include Mylan Laboratories, Ipca Laboratories, Mangalam Drugs & Organics, and Sanofi. These companies are profiled based on their product offerings, market entry year, and regional presence[1][3].

Market Dynamics

  • Drivers and Restraints: For both drugs, drivers include the increasing incidence of malaria, government initiatives, and technological advancements. Restraints include intense competition, the emergence of generics, and pricing pressures[1][3].
  • Opportunities and Challenges: Opportunities lie in the potential therapeutic applications beyond malaria, such as autoimmune and inflammatory conditions. Challenges include regulatory hurdles, the need for continuous innovation, and the impact of global health crises like the COVID-19 pandemic[2][3].

Regulatory Framework

Approval Status

  • Chloroquine Phosphate: Chloroquine phosphate has been widely approved for use in treating malaria and other conditions. However, its use has been subject to various regulatory scrutiny, especially during the COVID-19 pandemic[2].
  • Primaquine Phosphate: Primaquine phosphate has been approved globally since 1950 and is classified as an orphan drug, indicating its focus on rare diseases[4].

Regulatory Procedures

  • The setup of manufacturing plants for these drugs requires adherence to strict regulatory procedures, including those related to raw material sourcing, manufacturing processes, and quality control. Compliance with international standards and local regulations is essential for market approval and sustainability[2].

Technological Advancements

Drug Development Processes

  • Innovations in drug development processes, such as formulation techniques and delivery systems, enhance the efficacy and safety profiles of both chloroquine phosphate and primaquine phosphate. These advancements are critical in expanding their market presence[3].

Diagnostic Technologies

  • Improvements in diagnostic technologies enable quicker and more accurate detection of malaria, leading to timely administration of these drugs. This is particularly important for primaquine phosphate, which is used in the radical cure and relapse prevention of malaria[3].

Public Health Impact

Malaria Eradication Efforts

  • Both drugs are integral to global malaria eradication efforts. The increasing incidence of malaria and the growing resistance to conventional treatments underscore the importance of these antimalarial drugs in public health strategies[1][3].

Access to Healthcare

  • The availability and accessibility of these drugs in endemic regions are crucial. Investment in healthcare infrastructure and increased insurance coverage for antimalarial drugs promote early diagnosis and treatment, enhancing patient adherence to prescribed therapies[3].

Key Takeaways

  • Market Growth: Both chloroquine phosphate and primaquine phosphate markets are expected to grow significantly due to the increasing incidence of malaria and advancements in drug development.
  • Key Drivers: Drivers include the persistent prevalence of malaria, government initiatives, and technological advancements.
  • Competitive Landscape: The markets are highly competitive with key players investing heavily in innovation and marketing.
  • Regulatory Framework: Compliance with regulatory procedures is essential for market approval and sustainability.
  • Public Health Impact: These drugs are critical in global malaria eradication efforts and improving access to healthcare in endemic regions.

FAQs

What are the primary drivers for the chloroquine phosphate market?

The primary drivers include the persistent prevalence of malaria, especially in tropical and subtropical regions, and the drug's potential application in treating autoimmune and inflammatory conditions[2].

How does the COVID-19 pandemic impact the chloroquine phosphate market?

The COVID-19 pandemic has significantly impacted the market, with fluctuations in demand due to its initial exploration as a potential treatment for COVID-19, although this has been largely debunked[2].

What is the role of primaquine phosphate in malaria treatment?

Primaquine phosphate is primarily used for the radical cure and relapse prevention of malaria caused by the Plasmodium vivax parasite. It has been approved globally since 1950 and is classified as an orphan drug[4].

Who are the key players in the primaquine phosphate market?

Major players include Mylan Laboratories, Ipca Laboratories, Mangalam Drugs & Organics, and Sanofi. These companies are profiled based on their product offerings, market entry year, and regional presence[1][3].

How do technological advancements influence the market for these drugs?

Technological advancements in drug development processes, such as formulation techniques and delivery systems, enhance the efficacy and safety profiles of both drugs. Improvements in diagnostic technologies also enable quicker and more accurate detection of malaria[3].

Sources

  1. Market Research Intellect - Primaquine Phosphate API Market Size, Scope And Forecast Report[1]
  2. HackMD - Chloroquine Phosphate Manufacturing Plant[2]
  3. Verified Market Research - Primaquine Market Size, Scope, Growth, Trends and Forecast[3]
  4. Patsnap Synapse - Decoding primaquine phosphate: A Comprehensive Study of its R&D Trends[4]

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