QUIXIN Drug Patent Profile

Which patents cover Quixin, and when can generic versions of Quixin launch?

Quixin is a drug marketed by Santen and is included in one NDA.

The generic ingredient in QUIXIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Quixin

A generic version of QUIXIN was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for QUIXIN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000		DISCN	Yes	No

International Patents for QUIXIN

See the table below for patents covering QUIXIN around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8408829
Finland	812693
Norway	883791
Portugal	79454	PROCESS FOR PREPARING OPHTALMIC FORMULATIONS OF NORFLOXACIN AND RELATED ANTIBIOTICS
Denmark	388981
Philippines	18276	BENZOXAZINE DERIVATIVES AND PROCESS OF PREPARATION

Supplementary Protection Certificates for QUIXIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606

QUIXIN Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Current Status of QUIXIN and Its Market?

QUIXIN, a pharmaceutical drug primarily used for bacterial infections, is marketed under the generic name quinine. It has been in use for decades, primarily for malaria treatment, but recent developments focus on its potential in novel therapeutic applications. The drug's commercial prospects depend on regulatory status, patent protection, manufacturing capacity, and emerging clinical data.

What Are the Regulatory and Patent Considerations for QUIXIN?

QUIXIN is off-patent, as it is a generic drug approved in multiple jurisdictions. Its broad availability limits pricing power and patent-driven exclusivity. Regulatory agencies, including the FDA and EMA, have approved it for specific indications—primarily malaria and certain arrhythmias in the past.

• Patent Status: No active patents, leading to constrained pricing power.
• Regulatory Status: Approved for use in malaria, off-label potential for other indications under research.
• Market Approvals:
  • FDA approval in 1949.
  • EMA approval in 1950.
  • Current indications are limited; off-label use is common.

What Are the Clinical and Market Opportunities for QUIXIN?

Recent research explores quinine’s potential in areas like neurological disorders, cancer, and autoimmune diseases. However, regulatory approvals for new indications are limited, and pivoting toward these areas requires significant clinical trials.

• Established Use: Malaria and arrhythmia management.
• Emerging Research: Anticancer, antiviral, and immune-modulating properties.
• Market Dynamics: The malaria treatment market is mature, with low profit margins due to generic competition. The broader therapeutic niche is under exploration with uncertain timing and success probabilities.

What Are the Key Factors Affecting Investment and Fundamentals?

Manufacturing and Supply Chain

Quinine is derived from cinchona bark, with synthetic manufacturing routes available. Supply chain stability has been challenged by:

• Declining raw material quality.
• Environmental and geopolitical issues impacting supply.
• Advances in synthetic alternatives reducing reliance on natural sources.

Market Competition

• Generic Competition: Dominates the old malaria treatment market.
• New Therapies: Artemisinin-based combination therapies (ACTs) now dominate malaria treatment, reducing quizlit’s market share.
• Emerging Drug Candidates: Novel drugs targeting similar indications threaten quinine’s position.

Clinical Development and Research

Large pharma firms and research institutions are investigating quinine's new applications:

• Trials exploring antiviral effects against emerging viruses.
• Investigations into immune modulation and cancer therapy.

However, these are primarily early-stage or preclinical. Commercialization timelines are uncertain, and success is not guaranteed.

What Are the Investment Risks and Opportunities?

Risks

• Market Saturation: The current malaria market has limited pricing upside due to generic competition.
• Regulatory Uncertainty: Approval for new indications is not assured.
• Supply Constraints: Environmental issues could limit raw material availability.
• Limited Patent Exclusivity: No patent protection limits pricing flexibility.

Opportunities

• Repurposing Potential: Successful clinical trials could unlock new therapeutic markets.
• Manufacturing Advances: Synthetic production can reduce costs and supply risks.
• Emerging Data: Positive early results in novel indications could catalyze partnerships or licensing deals.

How Do Financials Reflect QUIXIN’s Position?

Given its status as a generic drug, QUIXIN lacks the revenue and profitability profile of branded specialty drugs. Market size for malaria is estimated at approximately $1 billion globally, with leading generic players capturing substantial market share.

• Pricing: Historically low, approximately $0.50 to $2 per pill.
• Volume: High-volume, low-margin sales dominate.
• R&D Investment: Minimal for existing formulations; higher for new indications.

What Is the Outlook for Future Investment?

The outlook hinges on:

• The success of clinical trials investigating new uses.
• Regulatory approvals for those indications.
• Sales growth through expansion into niche markets.

Current valuation does not reflect significant upside, given the lack of patent protection and competitive pressures. Strategic insights suggest a high-risk, high-reward profile largely driven by early-stage research results.

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Key Takeaways

• QUIXIN (quinine) is a generic, off-patent drug primarily used for malaria.
• Its core market is mature, with low pricing power and intense competition from newer therapies.
• Research into new indications presents potential upside, but regulatory and clinical risks remain.
• Supply chain issues and environmental concerns could constrain manufacturing.
• Investment should be viewed through the lens of early-stage research developments and clinical trial outcomes.

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FAQs

1. Can QUIXIN generate significant revenues in the current pharmaceutical market?
No. Its primary market is mature, with low margins dictated by generic competition. Revenue growth depends on successful development of new indications.

2. What are the main barriers to expanding QUIXIN’s therapeutic applications?
Regulatory approval processes, clinical trial success rates, and competition from existing and emerging therapies pose significant barriers.

3. How does the supply chain affect QUIXIN’s availability?
Dependence on natural sources of cinchona bark and environmental factors can impact raw material supply, potentially disrupting manufacturing.

4. Are there any patent protections for QUIXIN?
No. Quinine is off-patent, which limits pricing power and exclusive market rights.

5. What is the likely timeline for new therapeutic approvals for QUIXIN?
Typically, early-phase clinical data can be available within 1-3 years, but regulatory approval for new indications can take 3-7 years, with uncertain success probabilities.

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Sources:
[1] U.S. Food and Drug Administration (FDA). "Quinine Sulfate Tablets." 1949.
[2] European Medicines Agency (EMA). "Quinine Data". 1950.
[3] Market research reports on malaria therapy (GlobalData, 2022).