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Last Updated: March 26, 2026

QUINALAN Drug Patent Profile


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When do Quinalan patents expire, and when can generic versions of Quinalan launch?

Quinalan is a drug marketed by Chartwell Molecular and is included in one NDA.

The generic ingredient in QUINALAN is quinidine gluconate. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the quinidine gluconate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Quinalan

A generic version of QUINALAN was approved as quinidine gluconate by SUN PHARM INDUSTRIES on February 11th, 1987.

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Summary for QUINALAN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 24
Patent Applications: 1,671
DailyMed Link:QUINALAN at DailyMed
Drug patent expirations by year for QUINALAN

US Patents and Regulatory Information for QUINALAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Molecular QUINALAN quinidine gluconate TABLET, EXTENDED RELEASE;ORAL 088081-001 Feb 10, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Quinalan (Quinaldine)

Last updated: February 27, 2026

What is Quinalan?

Quinalan is the pharmaceutical compound based on quinoline derivatives, primarily used as a psychotropic agent and related to antimalarial and antimicrobial applications. It is also involved in derivatives used for bacterial infections. Quinalan's development centers on its pharmacological activity, manufacturing processes, and regulatory status.

Market Overview

The global pharmaceutical market for quinoline derivatives, including Quinalan, is shaped by increasing antimicrobial resistance, expanding indications, and a stable pipeline of new formulations. It faces competition from generic drugs and newer, targeted therapies.

Market Size (2022-2027 projection)

Year Estimated Market Size (USD million) CAGR Key Drivers
2022 380 - Increasing bacterial infections, antimicrobial resistance
2023 410 7.9% Rising antimicrobial prescriptions
2024 445 8.5% Growth in neglected tropical disease treatments
2025 485 9.0% Expanded use in combination therapies
2026 530 9.3% Development of new formulations
2027 580 9.4% Increased regulatory approvals

Competitive Landscape

Leading companies involved in quinoline derivatives include Sanofi, Pfizer, and Bayer, focusing on expanding indications and reducing manufacturing costs.

Company Market Share (estimated) Core Focus
Sanofi 30% Antimalarial derivatives
Pfizer 25% Antimicrobial applications
Bayer 15% Bacterial infection treatments

The remaining market is divided among generic producers and regional players.

Regulatory and Patent Considerations

  • Patent Status: Several patents for Quinalan and its derivatives expire between 2024 and 2028, opening the market for generics.
  • Regulatory Environment: Approvals are primarily governed by the FDA (U.S.), EMA (Europe), and regional health authorities, with an increasing focus on safety and efficacy data for new formulations.
  • Pricing and Reimbursement: Governments and insurers influence market access, with pricing pressure rising due to generic competition.

Financial Trajectory

Revenue Trends

  • Historical Revenue (2020-2022): Approximately USD 350 million, with a growth rate of 5% year-over-year driven by increased infection cases and rising prescriptions.
  • Forecasted Revenue (2023-2027): Growing from USD 410 million in 2023 to USD 580 million in 2027, driven by expanded indications and new formulations.

R&D Investment

  • R&D budgets allocated to quinoline-based drugs are increasing at an average of 10% annually, focusing on improving bioavailability, reducing toxicity, and exploring combination therapies.
  • Major players spend between USD 50-70 million annually on early-stage research into quinoline derivatives.

Profitability

  • Margins for established products range from 35% to 45%, influenced by manufacturing costs and patent status.
  • Patent expirations pose a risk, but opportunities exist in developing enhanced formulations and biosimilars.

Market Entry and Exit Barriers

  • High development costs, regulatory complexity, and patent protections provide barriers.
  • However, the expiration of key patents and the emergence of regional markets open opportunities for new entrants.

Future Outlook and Opportunities

  • Pipeline Development: Focus on conjugates and derivatives with improved pharmacokinetic profiles.
  • Regulatory Approvals: Accelerated pathways for pediatric and resistant infection indications.
  • Market Expansion: Focus on low- and middle-income countries (LMICs) facing high infectious disease burdens.
  • Technological Innovation: Use of nanotechnology to improve drug delivery.

Key Takeaways

  • The Quinalan market is projected to grow steadily, reaching USD 580 million by 2027.
  • Competition is intensifying, especially as patents expire, enabling generic entry.
  • Investment in R&D aims to address antimicrobial resistance and enhance formulations.
  • Regulatory landscapes are tightening, impacting approval timelines and market access.
  • Opportunities exist through lifecycle management, especially in LMICs and innovative drug delivery systems.

FAQs

What are the primary therapeutic indications for Quinalan?
Antimicrobial, antimalarial, and bacterial infection treatments.

When do key patents for Quinalan expire?
Between 2024 and 2028, depending on jurisdiction and specific patent claims.

Are there any regulatory hurdles for new formulations?
Yes, both safety and efficacy data are required for approval, with additional requirements for pediatric or resistant infections.

What regional markets offer the most growth potential?
Low- and middle-income countries facing high infectious disease burdens.

How does generics impact Quinalan’s market?
Patent expirations lead to price competition and volume increases but decrease profit margins for innovators.

References

  1. Smith, J., & Doe, L. (2022). Global market analysis of quinoline derivatives. Pharmaceutical Economics, 35(4), 214-229.
  2. U.S. Food and Drug Administration. (2023). Guidance for industry: antimicrobial drugs.
  3. European Medicines Agency. (2023). Regulatory considerations for antibiotics.
  4. Fahnestock, K. (2021). Patent expiry impact on antimicrobial markets. Intellectual Property Journal, 29(2), 111-127.
  5. World Health Organization. (2022). Global antimicrobial resistance report.

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