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Last Updated: March 27, 2025

PLAQUENIL Drug Patent Profile


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Which patents cover Plaquenil, and what generic alternatives are available?

Plaquenil is a drug marketed by Advanz Pharma and is included in one NDA.

The generic ingredient in PLAQUENIL is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

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Summary for PLAQUENIL
Drug patent expirations by year for PLAQUENIL
Drug Prices for PLAQUENIL

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Drug Sales Revenue Trends for PLAQUENIL

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Recent Clinical Trials for PLAQUENIL

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SponsorPhase
Incannex Healthcare LtdPhase 2
Yoo-min KimPhase 3
Ministry of Health & Welfare, KoreaPhase 3

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Pharmacology for PLAQUENIL

US Patents and Regulatory Information for PLAQUENIL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Advanz Pharma PLAQUENIL hydroxychloroquine sulfate TABLET;ORAL 009768-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  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 1 of 1 entries

Market Dynamics and Financial Trajectory for Plaquenil (Hydroxychloroquine)

Overview of Plaquenil

Plaquenil, also known as hydroxychloroquine, is a versatile drug used in the treatment of various health conditions, including malaria, rheumatoid arthritis, lupus erythematosus, and, in some cases, COVID-19. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global hydroxychloroquine market is anticipated to experience significant growth over the coming years. According to various reports, here are some key projections:

  • The market is expected to reach $1.8 billion by 2030, growing at a CAGR of 10.3% from 2021 to 2030[3].
  • Another forecast indicates that the market will grow to $2.86 billion by 2028 at a CAGR of 6.6%[2].
  • By 2034, the market is projected to attain a value of $6.85 billion, growing at a steady 5% CAGR from 2024 to 2034[4].

Regional Market Analysis

Asia-Pacific

The Asia-Pacific region, particularly India and China, dominates the hydroxychloroquine market. India is the largest supplier of pharmaceuticals globally, and the region's high demand for medications due to increasing cases of malaria, COVID-19, and other diseases drives market growth. The geriatric population in countries like Japan and India also contributes to the market's expansion[1].

North America

The North American market is forecasted to expand at a CAGR of 4.3% from 2024 to 2034. The U.S. market, in particular, is significant due to the high prevalence of rheumatoid arthritis, with approximately 54.4 million adults diagnosed and a projected increase to 78 million by 2040[2][4].

Europe and Other Regions

Europe and other regions, such as Latin America and the Middle East, also contribute to the global market. However, the growth rates in these regions are generally lower compared to Asia-Pacific and North America[1][4].

Market Segmentation

By Product Type

The market is segmented into tablets and active pharmaceutical ingredients (APIs). The tablet form is the most commonly used and accounts for a significant share of the market[1].

By Distribution Channel

The distribution channels include hospital pharmacies, online pharmacies, specialty drug stores, and retail pharmacies. Hospital pharmacies are expected to dominate the market due to government initiatives for treating diseases like malaria in rural areas[1].

By Disease

Hydroxychloroquine is used to treat various diseases, including malaria, rheumatoid arthritis, lupus erythematosus, and COVID-19. The increasing prevalence of rheumatoid arthritis and other autoimmune diseases is a key driver for the market[1][2][3].

Key Drivers of Market Growth

Increasing Prevalence of Autoimmune Diseases

The rising cases of rheumatoid arthritis, lupus, and other autoimmune diseases are significant drivers for the hydroxychloroquine market. For instance, the CDC projects that the number of adults diagnosed with arthritis in the U.S. will increase from 54.4 million to 78 million by 2040[2].

COVID-19 Impact

The COVID-19 pandemic has heightened the demand for hydroxychloroquine, despite its controversial use in treating the virus. This increased demand has contributed to the market's growth[1][2][4].

Government Initiatives and Funding

Government funding initiatives and improved access to healthcare services are also driving the market. For example, Aspen Pharmaceutical Corporation received substantial funding to bolster its hydroxychloroquine manufacturing in Brazil[2].

Challenges and Regulatory Concerns

Side Effects and Regulatory Issues

The long-term use of hydroxychloroquine is associated with side effects such as severe hypoglycemia and QT interval prolongation, which can increase the risk of Torsade de pointes and sudden cardiac death. These side effects, along with regulatory concerns, pose significant obstacles to market growth[4][5].

Quality of Drugs

The effectiveness of hydroxychloroquine against malaria is compromised in areas where chloroquine resistance is prevalent. This has led to advocacy for better quality control of drugs to ensure malaria control[3].

Competitive Landscape

The hydroxychloroquine market is highly competitive, with several key players vying for market share. These include:

  • Sanofi
  • Amneal Pharmaceuticals, Inc.
  • Mylan N.V.
  • Teva Pharmaceutical Industries Ltd.
  • Novartis AG
  • Zydus Cadila
  • Dr. Reddy’s Laboratories Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Lupin Limited
  • Prasco Laboratories
  • Abcam Plc.
  • Advanz Pharma Group
  • Bayer AG[2][3][4].

These companies are focusing on expanding production capacities, developing new formulations, and engaging in strategic mergers and acquisitions to maintain their market positions.

Market Developments and Strategies

Key market players are investing heavily in research and development to explore new potential uses for hydroxychloroquine. For example, Sanofi and Asahi Kasei Pharma Corporation have executed a marketing license agreement to expand the availability of Plaquenil in Japan[2].

New formulations and delivery methods aimed at improving patient compliance and reducing side effects are also being developed. These initiatives are expected to enhance treatment experiences and contribute to market growth[4].

Key Takeaways

  • The global hydroxychloroquine market is expected to grow significantly, driven by the increasing prevalence of autoimmune diseases and the impact of COVID-19.
  • Asia-Pacific, particularly India and China, dominates the market due to high demand and large pharmaceutical manufacturing capabilities.
  • North America is another significant market, driven by the high prevalence of rheumatoid arthritis.
  • Regulatory concerns and side effects associated with long-term use are challenges that need to be addressed.
  • Key players are focusing on R&D, new formulations, and strategic partnerships to maintain market share.

FAQs

What is the projected growth rate of the global hydroxychloroquine market?

The global hydroxychloroquine market is projected to grow at a CAGR ranging from 5% to 10.3% over the forecast period, depending on the source and specific projections[2][3][4].

Which region dominates the hydroxychloroquine market?

The Asia-Pacific region, particularly India and China, dominates the hydroxychloroquine market due to the presence of major pharmaceutical manufacturers and high demand for medications[1].

What are the key drivers of the hydroxychloroquine market?

Key drivers include the increasing prevalence of autoimmune diseases like rheumatoid arthritis, the impact of COVID-19, and government initiatives and funding for healthcare services[1][2][4].

What are the main challenges facing the hydroxychloroquine market?

Challenges include side effects associated with long-term use, regulatory concerns, and the compromised effectiveness of hydroxychloroquine against malaria in areas with chloroquine resistance[3][4][5].

Who are the key players in the hydroxychloroquine market?

Key players include Sanofi, Amneal Pharmaceuticals, Inc., Mylan N.V., Teva Pharmaceutical Industries Ltd., Novartis AG, and several others[2][3][4].

How are market players addressing the challenges in the hydroxychloroquine market?

Market players are focusing on research and development to explore new uses, developing new formulations to improve patient compliance, and engaging in strategic partnerships to enhance market presence[2][4].

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