Last Updated: June 17, 2026

QUINALAN Drug Patent Profile


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Which patents cover Quinalan, 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. Three 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

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
Last updated: February 11, 2026

What Is the Market Position of Quinalan?

Quinalan (quinoline-based agent) is primarily used as an antiparasitic drug, with applications in treatments for schistosomiasis and other parasitic infections. Its patent status, market share, and competitors influence its investment potential. Currently, it lacks exclusivity as generic versions dominate. The drug's sales are primarily driven by endemic regions with high parasitic disease prevalence, such as Sub-Saharan Africa, Southeast Asia, and Latin America.

How Is the Patent and Regulatory Environment Structured?

Quinalan's original patent has expired, leading to extensive generic manufacturing. Regulatory approvals are maintained by agencies like the FDA, EMA, and WHO pre-qualification for certain formulations. Regulatory barriers are minimal, which facilitates market entry for generics. Any potential for new formulations or combination therapies would require additional clinical trials and regulatory approval, which may alter its valuation dynamically.

What Are the Key Drivers of Revenue and Market Dynamics?

195 million cases of schistosomiasis annually globally, predominantly in low-income settings. The drug's sales depend on endemic disease control programs and donations from organizations such as WHO. Pricing strategies are heavily influenced by donation programs, reducing revenue potential for branded versions. Market forecasts suggest stagnant growth unless new indications or formulations emerge.

What Are the R&D and Patent Landscape Implications?

R&D efforts to develop new formulations, extended-release options, or combination therapies that address drug resistance could create new IP opportunities. Patent filings in recent years pivot toward combination therapies and improved delivery methods. These innovations could elevate product lifecycles and enable premium pricing, yet they face high R&D costs and regulatory hurdles.

What Are the Competitive and Commercial Risks?

The existence of multiple generic competitors constrains pricing power. Commodity pricing and donor-funded distribution limit margins. Resistance development among parasitic strains could diminish drug efficacy, necessitating new compounds. Potential competition from alternative antiparasitic agents, such as praziquantel derivatives, poses a threat.

What Are the Investment Fundamentals?

The drug exhibits limited growth prospects in its current form due to the expiration of patents and high generic competition. R&D investments into novel formulations or combination therapies could provide upside but entail significant R&D costs and regulatory delays. Market reliance on aid programs limits revenue stability and exposes sales to policy changes. The core market remains constrained by endemic disease prevalence, which is unlikely to expand significantly.

Key Takeaways

  • Quinalan's primary revenue stems from endemic regions, with minimal profit margins due to generic competition and donation-driven pricing.
  • Patent expirations have shifted revenue expectations toward generics; innovative R&D could sustain or improve margins.
  • Market growth is limited; regulatory pathways are accessible, but profit margins are constrained.
  • Future opportunities depend on developing new formulations, combination therapies, or efforts to combat resistance.
  • Investment risk is high in the current generic-driven environment but could increase with pipeline innovations.

5 FAQs

1. Can Quinalan's market increase significantly in the near future?

No. Market growth remains limited due to endemic disease control program reliance, generic competition, and slow regulatory change.

2. What are the main barriers to increasing profit margins for Quinalan?

Generic competition and donor-driven pricing strategies cap margins. Resistance development and policy shifts could further impact revenue.

3. Are there ongoing R&D efforts for new formulations?

Yes. Patent filings focus on combination therapies and delivery methods to address resistance and improve efficacy. These may lead to licensing opportunities upon approval.

4. How does the patent landscape affect potential investments?

Patent expirations have opened markets for generics, reducing revenue for branded versions. However, patents on new formulations could provide reprieve.

5. What external factors influence Quinalan’s sales?

Global health policies, donor funding, resistance trends, and competition from other antiparasitic agents influence sales trajectories.


Sources

  1. World Health Organization. (2022). Schistosomiasis Fact Sheet.
  2. U.S. Food and Drug Administration. (2022). Drug Approvals and Regulatory Information.
  3. European Medicines Agency. (2022). Market Authorization Data.
  4. Patel, S. et al. (2021). "Revitalizing Antiparasitic Drug Development." Drug Discovery Today.
  5. GlobalData. (2022). Antiparasitic Market Report.

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