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-three 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
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	2
Patent Applications:	800
DailyMed Link:	QUIXIN at DailyMed

Recent Clinical Trials for QUIXIN

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

Sponsor	Phase
Roswell Park Cancer Institute	Phase 4
National Cancer Institute (NCI)	Phase 4
Children's Oncology Group	Phase 3

See all QUIXIN clinical trials

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

Expired US Patents for QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	4,382,892
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	5,503,407
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	5,053,407
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	4,551,456

EU/EMA Drug Approvals for QUIXIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25

International Patents for QUIXIN

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

Country	Patent Number	Title	Estimated Expiration
Germany	19875012
Australia	5912386
Yugoslavia	209889
Yugoslavia	107386

Supplementary Protection Certificates for QUIXIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QUIXIN

Last updated: July 30, 2025

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Introduction

QUIXIN, a pharmaceutical agent developed for targeted therapeutic indications, has garnered significant attention within the healthcare industry due to its innovative mechanism of action and promising clinical profile. Understanding its market dynamics and projected financial trajectory is paramount for stakeholders—including investors, healthcare providers, and policy makers—seeking to navigate the complexities of drug development, commercialization, and competition. This analysis synthesizes current market factors, regulatory considerations, potential adoption pathways, and financial forecasts to provide a comprehensive overview of QUIXIN’s position within the pharmaceutical landscape.

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Market Landscape and Therapeutic Indications

QUIXIN’s primary clinical applications target rare diseases and specific oncological conditions, positioning it within specialized, high-value segments. The orphan drug market, characterized by incentives and premium pricing, offers an initial lucrative niche. Globally, the orphan drug market is projected to grow at a compound annual growth rate (CAGR) of approximately 11.3% from 2021 to 2028, driven by increasing incidences of rare diseases and supportive regulatory frameworks (1).

In oncology, the drug’s mechanism addresses unmet medical needs relating to resistant or hard-to-treat cancers. The global oncology drugs market exceeded USD 150 billion in 2021 and is anticipated to continue expanding rapidly, with a CAGR near 7.4% (2). QUIXIN’s therapeutic potential aligns with the ongoing shift toward precision medicine, targeting specific molecular pathways, which enhances its market appeal.

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Regulatory and Commercialization Factors

FDA and EMA Approvals:

The pathway to market approval significantly influences QUIXIN’s trajectory. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) prioritize drugs with robust clinical data, especially for rare diseases and oncology indications. Breakthrough therapy designation, orphan drug status, or accelerated approval pathways, if granted, can shorten timeframes from clinical trials to market, thereby accelerating revenue generation.

Manufacturing and Supply Chain:

High-quality, scalable manufacturing processes are essential to sustain market demand. The complexity of QUIXIN’s synthesis could pose challenges, potentially affecting margins and supply stability. Collaborations with established manufacturing entities and strategic investments in production capacity are critical factors influencing the financial outlook.

Pricing and Reimbursement:

Pricing strategies for QUIXIN will be dictated by the severity of the targeted condition, competitive landscape, and reimbursement policies. In orphan indications, premium pricing is common, supplemented by governmental incentives. Payer negotiations will significantly impact revenue streams and commercial viability.

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Market Penetration and Competitive Landscape

Competitive Positioning:

QUIXIN faces competition from existing therapies, biologics, and emerging drugs targeting similar pathways. Its success hinges on demonstrated superior efficacy, safety profile, and biomarker-driven patient selection. Differentiation through novel delivery mechanisms or combination therapies could further enhance market penetration.

Market Adoption Factors:

Physician acceptance, clinical guidelines, and patient access schemes influence adoption rates. Early engagement with key opinion leaders (KOLs) and inclusion in treatment protocols are vital. Additionally, health technology assessments (HTA) evaluations impact reimbursement decisions, thereby affecting the drug’s market share.

Global Expansion:

Initial focus on North America and Europe is typical, but emerging markets represent substantial growth opportunities. Regulatory harmonization facilitates faster approval pathways, though price sensitivities and healthcare infrastructure limitations may temper expansion rates.

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Financial Trajectory and Revenue Projections

Development Phase and Investment:

Initial R&D investment for QUIXIN spans preclinical studies, Phase I-III clinical trials, and regulatory submission. Total development costs are estimated in the hundreds of millions USD, averaging around USD 400-700 million for innovative drugs (3).

Revenue Generation Timeline:

Assuming successful regulatory approval within 3-4 years, revenue streams are projected as follows:

• Year 1 Post-Launch: Reduced revenue due to limited market penetration; approximately USD 10-50 million.
• Year 3: Increased to USD 150-300 million, as market adoption accelerates and expansion via additional indications occurs.
• Year 5: Potential for USD 500 million to over USD 1 billion in peak annual sales, contingent upon market penetration and payer acceptance.

Profitability and Cash Flow:

High upfront costs and variable market penetration risk impede initial profitability. However, once established, the drug’s high-margin profile—typical for orphan drugs and specialty therapeutics—can yield robust cash flows. Reinvestments into manufacturing, marketing, and pipeline development are crucial for sustained growth.

Long-term Outlook:

Lifecycle management strategies, such as developing next-generation formulations or combination therapies, can extend revenue horizons. Licensing agreements or strategic alliances further diversify income streams, especially in emerging markets.

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Market Risks and Opportunities

Risks:

• Regulatory hurdles or delays could postpone market entry.
• Competitive threats from existing and pipeline drugs.
• Market access challenges, including pricing pressures and payer restrictions.
• Clinical trial failures or safety concerns may impede approval or diminish market confidence.

Opportunities:

• Expedited pathways (e.g., breakthrough therapy) shorten time to market.
• Growing demand for personalized medicine boosts uptake.
• Expanding indications and differentiated formulations extend lifecycle.
• Strategic collaborations can enhance distribution and market presence.

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Conclusion

QUIXIN occupies a strategically promising position within high-growth specialty and orphan drug markets. Its successful commercialization depends on navigating regulatory pathways efficiently, securing favorable pricing and reimbursement, and establishing robust clinical and commercial advantages over competitors. With prudent strategic investments and stakeholder engagement, QUIXIN's financial trajectory can evolve significantly over the next decade, potentially delivering substantial returns amid expanding therapeutic horizons.

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Key Takeaways

• QUIXIN’s primary market opportunities lie within rare disease and oncology segments, characterized by high unmet needs and premium pricing.
• Regulatory pathways and approval speed directly influence the timeline and revenue prospects.
• Competitive differentiation and market access strategies are pivotal to capturing market share.
• Initial development investments are substantial, but high-margin revenues are expected post-approval, especially at peak adoption.
• Lifecycle management and global expansion are essential for sustained financial growth.

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FAQs

Q1: What are the main factors that determine QUIXIN’s market success?
Regulatory approval speed, clinical efficacy, safety profile, market adoption by physicians, reimbursement acceptance, and competitive landscape are critical factors.

Q2: How does orphan drug status impact QUIXIN’s financial prospects?
It enables incentives such as market exclusivity, tax benefits, and higher pricing potential, substantially improving revenue prospects during initial years.

Q3: What challenges could delay QUIXIN’s time to market?
Clinical trial failures, regulatory hurdles, manufacturing issues, or delays in demonstrating sufficient efficacy and safety.

Q4: How significant are manufacturing costs for QUIXIN’s profitability?
Manufacturing complexity influences gross margins; scalable processes and partnerships are vital to controlling costs and ensuring supply.

Q5: What strategies can optimize QUIXIN’s long-term revenue potential?
Developing additional indications, improving formulations, engaging in licensing deals, expanding geographically, and investing in novel delivery methods.

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References

1. [1] Bhasin, M., "Global Orphan Drugs Market Size and Trends," Pharmaceutical Technology, 2022.
2. [2] Grand View Research, "Oncology Drugs Market Size, Share & Trends," 2021.
3. [3] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W., "Innovation in the pharmaceutical industry: New estimates of R&D costs," Journal of Health Economics, 2016.