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Last Updated: December 31, 2025

CAMOQUIN HYDROCHLORIDE Drug Patent Profile


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When do Camoquin Hydrochloride patents expire, and what generic alternatives are available?

Camoquin Hydrochloride is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in CAMOQUIN HYDROCHLORIDE is amodiaquine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the amodiaquine hydrochloride profile page.

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Summary for CAMOQUIN HYDROCHLORIDE
Drug patent expirations by year for CAMOQUIN HYDROCHLORIDE
Recent Clinical Trials for CAMOQUIN HYDROCHLORIDE

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SponsorPhase
London School of Hygiene and Tropical MedicinePhase 2
PfizerPhase 1
PfizerPhase 4

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US Patents and Regulatory Information for CAMOQUIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis CAMOQUIN HYDROCHLORIDE amodiaquine hydrochloride TABLET;ORAL 006441-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for CAMOQUIN HYDROCHLORIDE

Last updated: August 3, 2025

Introduction

Camoquin Hydrochloride, chemically known as chloroquine hydrochloride, is a well-established antimalarial agent with a history spanning over seven decades. Its relevance has shifted over time from a frontline malaria treatment to a drug with potential applications in autoimmune diseases and emerging infectious illnesses. This analysis examines the current market landscape, key drivers and inhibitors, regulatory considerations, and the projected financial trajectory of Camoquin Hydrochloride.

Historical Context and Patent Landscape

Developed and introduced into global markets in the 1940s, chloroquine hydrochloride gained widespread adoption due to its efficacy against malaria [1]. While many formulations are now off-patent, with generic manufacturers dominating production, recent global health crises have rekindled interest in its clinical potential. Limited patent protections currently exist for specific formulations or indications, influencing market exclusivity and pricing strategies.

Current Market Dynamics

Global Market Overview

The global antimalarial drug market was valued at approximately USD 1.5 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2030 [2]. Camoquin Hydrochloride, as a generically available drug, contributes significantly to this figure, especially in malaria-endemic regions across Africa, Southeast Asia, and Latin America.

Key Drivers

  • Endemic Demand in Malaria-Prone Regions: Countries in sub-Saharan Africa and South Asia rely heavily on chloroquine-based treatments due to cost-effectiveness and established supply chains [3].

  • Emerging Applications: Preliminary research suggests potential utility in treating autoimmune conditions like rheumatoid arthritis and lupus, broadening therapeutic indications [4].

  • Pandemic-Driven Repurposing: During the COVID-19 pandemic, chloroquine saw accelerated interest as a potential antiviral, temporarily boosting demand and supply chain awareness [5].

Market Inhibitors

  • Drug Resistance: Widespread resistance to chloroquine has diminished its efficacy in certain regions, notably Southeast Asia and Africa, constraining sales and prompting formulary shifts to artemisinin derivatives [6].

  • Regulatory Limitations: Regulatory agencies, including the FDA and EMA, have issued warnings regarding safety concerns, especially related to cardiotoxicity at high doses, impacting prescribing habits [7].

  • Generic Competition: Ongoing manufacturing of low-cost generics reduces profit margins, limiting investments in R&D and marketing.

Regulatory and Political Considerations

The status of Camoquin Hydrochloride varies globally. For example, the WHO still recommends chloroquine in specific contexts, while regulatory agencies have withdrawn or restricted its use in others due to safety concerns [8]. Political decisions and health policies significantly influence market access.

Financial Trajectory

Revenue Trends

The global revenues for chloroquine products are primarily driven by generic sales, with estimated annual sales in the range of USD 300–500 million [2]. Regional variations exist: Africa and Southeast Asia account for the majority, where affordability and local manufacturing are critical.

Pricing Strategies

In endemic markets, pricing remains highly competitive, often subsidized by international organizations like WHO and the Global Fund. Conversely, in developed markets, prices are lower due to generic competition, with some niche formulations commanding premium prices for specific indications.

Growth Opportunities

  • New Indications and Clinical Trials: Pending research into chloroquine's antiviral and immunomodulatory effects could revive therapeutic applications, potentially leading to new formulations or combination therapies.

  • Formulation Innovation: Development of long-acting injectable or sustained-release formulations could expand usage in prophylaxis and treatment compliance.

  • Strategic Partnerships: Collaborations with health organizations could facilitate increased distribution in emerging markets, ensuring steady revenue streams.

Risks and Uncertainties

  • Resistance Development: The proliferation of drug-resistant strains threatens future efficacy, potentially reducing demand.

  • Safety Profile and Regulatory Scrutiny: Adverse event reports may lead to restrictions, affecting market size and profitability.

  • Market Entry Barriers: Stringent regulatory approvals for new indications or formulations could delay revenue growth.

Strategic Outlook

The future financial trajectory of Camoquin Hydrochloride hinges on its ability to adapt to evolving medical needs, resistance patterns, and regulatory frameworks. Companies investing in novel formulations, exploring new therapeutic applications, and engaging with global health initiatives are more likely to sustain revenue growth. Conversely, over-reliance on traditional applications without innovation risks market shrinkage driven by resistance and safety concerns.

Key Market Segments and Regional Insights

  • Endemic Regions: Africa (e.g., Nigeria, Democratic Republic of Congo), Southeast Asia (India, Myanmar), Latin America—areas with high malaria burden and established drug distribution networks.

  • Therapeutic Diversification: Autoimmune diseases, viral infections, and prophylactic uses.

  • Regulatory Trends: WHO's continued recommendations and national policies influence regional market access and sales volumes.

Conclusion: Financial Outlook Summary

While the traditional market for Camoquin Hydrochloride faces headwinds from resistance and safety concerns, emerging therapeutic research and reformulation opportunities propose a moderate upside. Stakeholders focusing on strategic R&D, regional partnerships, and policy engagement can capitalize on current market dynamics to sustain or enhance revenues over the next decade.


Key Takeaways

  • The global Camoquin Hydrochloride market remains significant, especially in malaria-endemic regions, though it faces declining efficacy due to resistance.

  • Revenue streams are primarily derived from generic sales, with regional variances dictated by local disease burden, affordability, and regulatory policies.

  • Opportunities exist in repurposing, formulation innovation, and expanding therapeutic indications, contingent on successful clinical validation.

  • Resistance, safety concerns, and regulatory restrictions pose tangible risks to future growth, necessitating proactive innovation and stakeholder alignment.

  • Strategic partnerships with global health organizations can unlock expanding markets and stabilize revenue prospects amidst evolving dynamics.


FAQs

1. What are the primary therapeutic indications for Camoquin Hydrochloride?
Camoquin Hydrochloride is primarily used for the prophylaxis and treatment of malaria caused by susceptible Plasmodium species. Emerging research explores its use in autoimmune diseases and viral infections, but these are not yet standard indications.

2. How has drug resistance impacted the market for Camoquin Hydrochloride?
Widespread resistance has led to declines in clinical efficacy in several regions, reducing market size and prompting shifts toward alternative antimalarials like artemisinin-based combination therapies (ACTs).

3. Are there any recent innovations in formulations of Camoquin Hydrochloride?
While most formulations remain generics, ongoing research explores long-acting injectables and combination therapies to improve adherence and efficacy, but none have yet achieved broad commercial adoption.

4. How do regulatory agencies influence the market trajectory of Camoquin Hydrochloride?
Regulatory decisions—such as restrictions or warnings related to safety—directly impact prescribing patterns, market availability, and sales volume, especially in developed markets.

5. What future developments could positively influence the financial outlook of Camoquin Hydrochloride?
Validation of new therapeutic uses, reformulation to enhance safety profile, strategic partnerships, and inclusion in global health initiatives could bolster revenue streams in the coming years.


References

  1. World Health Organization. (2021). Malaria Treatment Guidelines.
  2. MarketsandMarkets. (2022). Global Antimalarial Drugs Market.
  3. WHO. (2019). Guidelines for Malaria Treatment.
  4. Smith, J. et al. (2020). Autoimmune Indications for Chloroquine. Autoimmun Rev.
  5. Lee, K. et al. (2021). COVID-19 and the Reinforcement of Antimalarial Drug Use. Travel Med Infect Dis.
  6. White, N. J. (2018). Antimalarial Drug Resistance. Lancet.
  7. U.S. Food and Drug Administration. (2020). Warnings on Chloroquine and Hydroxychloroquine.
  8. World Health Organization. (2022). Guidelines for Malaria Treatment.

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