You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

QUALAQUIN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Four 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.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for QUALAQUIN?
  • What are the global sales for QUALAQUIN?
  • What is Average Wholesale Price for QUALAQUIN?
Summary for QUALAQUIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 3
Patent Applications: 2,506
Drug Prices: Drug price information for QUALAQUIN
What excipients (inactive ingredients) are in QUALAQUIN?QUALAQUIN excipients list
DailyMed Link:QUALAQUIN at DailyMed
Drug patent expirations by year for QUALAQUIN
Drug Prices for QUALAQUIN

See drug prices for QUALAQUIN

Recent Clinical Trials for QUALAQUIN

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

SponsorPhase
Mutual Pharmaceutical Company, Inc.Phase 1

See all QUALAQUIN clinical trials

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 ⤷  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 the Pharmaceutical Drug: QUALAQUIN

Last updated: August 1, 2025


Introduction

QUALAQUIN, primarily known as a historical antimalarial drug, has garnered renewed interest amid contemporary health crises, particularly in the context of emerging infectious diseases. Its evolving market dynamics and projected financial trajectory reflect broader shifts in global healthcare, drug development priorities, and regulatory landscapes. This analysis dissects the key drivers shaping QUALAQUIN's market, evaluates its growth potential, and projects its financial performance, instrumental for strategic decision-making.


Historical Context and Therapeutic Profile of QUALAQUIN

Originally developed in the early 20th century, QUALAQUIN's chemical core is 4-aminoquinoline, sharing structural similarity with chloroquine. It was widely utilized for malaria prophylaxis and treatment, particularly in endemic regions such as Africa and Southeast Asia. However, its use declined with the emergence of drug-resistant Plasmodium strains and the advent of newer antimalarials with improved safety profiles.

Notably, QUALAQUIN's mechanism involves inhibition of parasite heme detoxification, but its efficacy varies against resistant strains. Beyond malaria, its off-label consideration for autoimmune diseases has driven limited but notable niche interest. Its pharmacokinetics are characterized by high bioavailability and extensive tissue distribution, impacting its usage patterns and manufacturing considerations.


Market Drivers Influencing QUALAQUIN

1. Resurgence Due to COVID-19 and Off-Label Uses
The COVID-19 pandemic underscored the potential repurposing of existing antimalarials like QUALAQUIN. Early in the pandemic, studies explored its antiviral activity, leading to emergency use authorizations in some regions. Although subsequent rigorous trials largely discredited these claims, the initial surge demonstrated the drug’s visibility in infectious disease management and spurred renewed research initiatives.

2. Resistance Patterns and Public Health Policies
Growing resistance to chloroquine and related drugs curtailed their frontline use in malaria. However, with ongoing research into combination therapies and dosing modifications, QUALAQUIN remains relevant in specific regions. The WHO’s recommendations and the evolving resistance landscape significantly influence its market viability.

3. Regulatory and Patent Landscape
Most formulations of QUALAQUIN are off-patent, enabling generic manufacturing, which facilitates widespread accessibility but constrains pricing power for pharmaceutical companies. Regulatory approvals for new indications or formulations depend heavily on clinical trial efficacy, impacting future market expansion possibilities.

4. Geographic and Demographic Shifts
High burden of malaria in Africa, Asia, and Latin America sustains the demand for affordable antimalarials like QUALAQUIN. Population growth, urbanization, and healthcare infrastructure enhancements influence distribution channels and sales volumes.

5. Competitive Landscape
The market hosts multiple generics, including chloroquine and amodiaquine, with competitors in different segments of the antimalarial realm. The emergence of novel drugs with improved efficacy or safety profiles—such as artemisinin-based combination therapies—affects QUALAQUIN's market share.


Pharmaceutical Development and Innovation

While the core drug remains the same, ongoing research explores novel analogs, combination regimens, and advanced delivery systems. These innovations aim to enhance safety, reduce resistance, and widen indications, potentially altering its market trajectory.


Market Size and Financial Trajectory

1. Current Market Landscape
The global antimalarial drugs market was valued at approximately $1.4 billion in 2021, with generics accounting for a significant majority. QUALAQUIN’s share, dominated by generic formulations, is estimated to be around $150-250 million, primarily in endemic regions.

2. Revenue Drivers and Forecasts
Short-term revenues are expected to remain stable or slightly decline due to competitive pressures and declining use in malaria therapy where resistance is significant. However, potential niche applications, such as adjunct therapies in autoimmune diseases, could generate incremental growth.

Long-term, the market’s trajectory hinges on several factors:

  • Adoption in new indications, contingent upon clinical validation.
  • Geographic expansion into emerging markets with rising disease prevalence.
  • Advances in combination therapy regimens boosting demand.

3. Impact of Regulatory Changes
Regulatory approvals or restrictions significantly influence sales. For example, restrictions on off-label use in certain jurisdictions could limit penetration, while approvals for new formulations or indications might accelerate growth.

4. Supply Chain and Manufacturing Considerations
The off-patent status facilitates large-scale generic manufacturing, minimizing costs and increasing accessibility. Yet, supply chain disruptions, especially amid geopolitical or health crises, could influence pricing and availability, affecting revenue stability.

5. Future Scenario Modeling

  • Best-Case Scenario: Adoption of QUALAQUIN in new indications, expansion into emerging markets, and patent extensions or new formulations could propel revenues to over $500 million within 5 years.
  • Moderate Scenario: Continued generic competition, limited approval for new uses, with revenues stabilizing around $200-300 million.
  • Worst-Case Scenario: Regulatory restrictions and obsolescence due to newer drugs lead to decline below $100 million.

Regulatory Outlook and Strategic Implications

Regulatory agencies’ stance on off-label uses, particularly in infectious diseases, influences future prospects. The FDA and EMA’s evolving policies toward older antimalarials, especially given the re-evaluation during COVID-19, dictate operational pathways. Engaging in clinical trials to establish efficacy for emerging indications could unlock new markets and enhance financial trajectories.


Conclusion

The market dynamics and financial outlook for QUALAQUIN hinge on evolving disease patterns, resistance development, regulatory environments, and innovative clinical research. Its position as a low-cost generic provides resilience in traditional malaria markets but constrains growth prospects absent new indications or formulations. Strategic investments in clinical validation, geographic expansion, and formulation innovation could diversify revenue streams and extend its market viability.


Key Takeaways

  • Market Stability in Endemic Regions: QUALAQUIN continues to serve as an essential, affordable antimalarial in Africa, Asia, and Latin America, driven by high disease burden and limited alternatives.

  • Growth Opportunities in Niche Indications: Research into autoimmune and off-label antiviral uses offers potential for incremental revenues, contingent on clinical validation.

  • Competitive and Regulatory Pressures: The generic landscape and evolving health policies necessitate strategic positioning to capitalize on market opportunities.

  • Innovation as a Catalyst: Developing new formulations or combination therapies could mitigate resistance issues and expand market share.

  • Crisis-Driven Exposure: Past surges during health crises like COVID-19 highlight the importance of adaptive research strategies for future resilience.


Frequently Asked Questions

1. What are the primary therapeutic uses of QUALAQUIN today?
QUALAQUIN is mainly used for malaria treatment and prophylaxis in regions where resistance to other drugs remains manageable. Its use in autoimmune diseases and investigational off-label applications also persists, though these are limited.

2. How does resistance affect QUALAQUIN’s market potential?
Increasing resistance among Plasmodium species has limited QUALAQUIN’s efficacy in some regions, reducing demand. However, in areas with known efficacy, resistance management and combination therapies preserve its role.

3. Are there any upcoming regulatory changes that might impact QUALAQUIN?
Regulatory bodies are scrutinizing older antimalarials to ensure safety and efficacy. Pending approvals for new indications or formulations could enhance its marketability, whereas restrictions could diminish its scope.

4. What is the revenue outlook for QUALAQUIN over the next five years?
While stable in traditional markets, its revenue trajectory depends on clinical development success, regulatory support, and geographic expansion, with potential to grow modestly or decline depending on these factors.

5. Can innovations extend QUALAQUIN’s market life?
Yes, developing new formulations, combination therapies, and securing approvals for emerging indications could significantly prolong its relevance and financial contribution.


References

[1] World Health Organization. (2021). World Malaria Report.
[2] MarketsandMarkets. (2022). Antimalarial Drugs Market Insights.
[3] U.S. Food and Drug Administration. (2022). Regulatory updates on antimalarial drugs.
[4] ClinicalTrials.gov. (2023). Ongoing studies involving QUALAQUIN and derivatives.
[5] IQVIA. (2022). Global Pharmaceutical Market Trends.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.