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Last Updated: December 22, 2024

QUALAQUIN Drug Patent Profile


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

Qualaquin is a drug marketed by Sun Pharm Industries and is included in one NDA.

The generic ingredient in QUALAQUIN is quinine sulfate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the quinine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Qualaquin

A generic version of QUALAQUIN was approved as quinine sulfate by TEVA PHARMS on September 28th, 2012.

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

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Recent Clinical Trials for QUALAQUIN

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SponsorPhase
Mutual Pharmaceutical Company, Inc.Phase 1

See all QUALAQUIN clinical trials

Pharmacology for QUALAQUIN
Drug ClassAntimalarial

US Patents and Regulatory Information for QUALAQUIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries QUALAQUIN quinine sulfate CAPSULE;ORAL 021799-001 Aug 12, 2005 DISCN Yes 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

QUALAQUIN Market Analysis and Financial Projection Experimental

Quinine Market Dynamics and Financial Trajectory: A Focus on Qualaquin

Introduction

Qualaquin, a brand name for quinine sulfate, is a crucial medication in the treatment of malaria and, though less recommended, for nocturnal leg cramps. Here, we delve into the market dynamics and financial trajectory of quinine, with a particular focus on Qualaquin.

Global Quinine Market Size and Growth

The global quinine market has been experiencing steady growth. As of 2021, the market size was valued at USD 1.8 billion and is projected to reach USD 2.6 billion by 2030, growing at a CAGR of 6% from 2022 to 2030[1][4].

Market Segmentation

The quinine market is segmented by type, application, administration, end-user, and region.

By Type

The market is dominated by the 200 mg segment, which held the maximum market share in 2021. Other types, including 300 mg and others, also contribute significantly to the market[1][3].

By Application

While malaria is a primary application, the "others" segment, which includes conditions like lupus and rheumatoid arthritis, is expected to witness high CAGR growth during the forecast period. However, the use of quinine for nocturnal leg cramps is increasingly discouraged due to its minimal effectiveness and significant side effects[1][3][5].

By Administration

Intramuscular administration is projected to hold the dominant market share throughout the forecast period, followed by oral and intravenous administrations[1].

By End User

Hospitals are the primary end-users, holding the dominant market share. Clinics and other healthcare facilities also contribute to the market demand[1].

Regional Analysis

Geographically, the Middle East and Africa region was the leading revenue generator in 2021, but the Asia-Pacific region is expected to see the most growth during the forecast period. This growth is driven by increasing healthcare spending, rising disposable income, and a high population base in countries like India[1][4].

Financial Trajectory of Qualaquin

Qualaquin, being the only FDA-approved quinine sulfate drug for treating malaria, plays a significant role in the market.

Market Size and Forecast

The quinine sulfate market, which includes Qualaquin, is expected to grow from USD 2.23 billion in 2023 to USD 2.41 billion in 2024 at a CAGR of 8.3%. By 2028, the market is forecasted to reach USD 3.33 billion[3].

Revenue Drivers

The growth of the quinine market, and thus Qualaquin, is driven by several factors:

  • Increasing Malaria Prevalence: Growing malaria cases, especially in tropical regions, drive the demand for anti-malarial treatments like quinine sulfate[3].
  • Healthcare Expenditure: Rising healthcare spending in developing nations and improving supply chains for raw materials contribute to market growth[3].
  • Regulatory Emphasis: Growing regulatory emphasis on drug safety and the global focus on malaria eradication strategies also support the market[3].

Challenges and Restraints

Despite the growth, there are challenges:

  • Side Effects and FDA Warnings: The FDA has issued warnings about the use of quinine for conditions other than malaria due to serious side effects and minimal effectiveness. This has led to a decrease in off-label prescriptions for conditions like nocturnal leg cramps[2][5].
  • Competition: The market is competitive, with several key players including Aecochem Corp, Haihang Industry Co. Ltd., Actavis, and Shreeji Pharma International, among others[1].

Competitive Landscape

The quinine market is dominated by a few key players, with Qualaquin being a significant brand. The competitive landscape includes strategic market developments such as acquisitions, mergers, partnerships, and new product launches. Companies like Aecochem Corp, Haihang Industry Co. Ltd., and Actavis are major players in this market[1].

Regulatory Environment

The FDA's stance on quinine is critical. While Qualaquin is approved for treating malaria, its use for other conditions is strictly regulated due to safety concerns. The FDA has banned the sale of unapproved quinine drugs and cautions against off-label use, which affects the market dynamics[2][5].

Consumer and Prescriber Trends

Despite FDA warnings, quinine is still prescribed off-label for conditions like nocturnal leg cramps, although this practice is declining. The rise in demand for tonic water, which contains quinine, also influences the market to some extent[1][2].

Key Takeaways

  • The global quinine market is expected to grow at a CAGR of 6% from 2022 to 2030.
  • Qualaquin, as the only FDA-approved quinine sulfate drug for malaria, plays a crucial role in the market.
  • The market is driven by increasing malaria prevalence, healthcare expenditure, and regulatory emphasis on drug safety.
  • Serious side effects and FDA warnings limit the use of quinine for conditions other than malaria.
  • The Asia-Pacific region is expected to see significant growth due to increasing healthcare spending and a high population base.

FAQs

What is the current market size of the global quinine market?

The global quinine market size was valued at USD 1.8 billion in 2021 and is projected to reach USD 2.6 billion by 2030[1].

Why is the use of quinine for nocturnal leg cramps discouraged?

The FDA has discouraged the use of quinine for nocturnal leg cramps due to its minimal effectiveness and the risk of serious side effects, including life-threatening adverse events[2][5].

Which region is expected to see the most growth in the quinine market?

The Asia-Pacific region is expected to see the most growth during the forecast period due to increasing healthcare spending, rising disposable income, and a high population base in countries like India[1][4].

What are the primary applications of quinine?

The primary applications of quinine include the treatment of malaria and, to a lesser extent, conditions like lupus and rheumatoid arthritis. However, its use for nocturnal leg cramps is not recommended[1][3].

Who are the key players in the quinine market?

Key players in the quinine market include Aecochem Corp, Haihang Industry Co. Ltd., Actavis, Shreeji Pharma International, and others[1].

Sources

  1. Custom Market Insights: Quinine Market Size, Trends, Share, Global Forecast To 2030
  2. Consumer Reports: Stop taking Quinine for night-time leg cramps
  3. The Business Research Company: Quinine Sulfate Global Market Report 2024
  4. Zion Market Research: Global Quinine Market Size, Share, Trends and Forecast 2032
  5. American Academy of Neurology: Symptomatic treatment for muscle cramps (an evidence-based review)

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