GATIFLOXACIN - Generic Drug Details

What are the generic drug sources for gatifloxacin and what is the scope of freedom to operate?

Gatifloxacin is the generic ingredient in three branded drugs marketed by Apotex Inc, Caplin, Hikma, Lupin Ltd, Rising, Sandoz, Allergan, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for gatifloxacin. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for GATIFLOXACIN

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	33
Patent Applications:	7,468
Drug Prices:	Drug price trends for GATIFLOXACIN
What excipients (inactive ingredients) are in GATIFLOXACIN?	GATIFLOXACIN excipients list
DailyMed Link:	GATIFLOXACIN at DailyMed

See drug prices for GATIFLOXACIN

See drug sales revenues for GATIFLOXACIN

Recent Clinical Trials for GATIFLOXACIN

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

Sponsor	Phase
Khyber Medical University Peshawar	Phase 1
Shaheed Benazir Bhutto University Sheringal Dir Upper	Phase 1
Laboratorios Sophia S.A de C.V.	Phase 3

See all GATIFLOXACIN clinical trials

Generic filers with tentative approvals for GATIFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		0.3%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for GATIFLOXACIN

Drug Class

Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for GATIFLOXACIN

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for GATIFLOXACIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYMAXID	Ophthalmic Solution	gatifloxacin	0.5 %	022548	1	2010-12-07
ZYMAR	Ophthalmic Solution	gatifloxacin	0.3 %	021493	1	2007-07-19

US Patents and Regulatory Information for GATIFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	204227-001	Jul 11, 2016	AT	RX	No	No
Caplin	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	213542-001	Nov 3, 2021	AT	RX	No	No
Hikma	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	203189-001	Sep 3, 2014		DISCN	No	No

Expired US Patents for GATIFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010

Market Dynamics and Financial Trajectory for Gatifloxacin

Last updated: July 28, 2025

Introduction

Gatifloxacin, a fourth-generation fluoroquinolone antibiotic, has historically played a significant role in bacterial infection management, especially for respiratory and urinary tract infections. Its development by several pharmaceutical entities positioned it as a potent alternative to earlier quinolones. However, regulatory challenges, evolving resistance patterns, and market competition have influenced its commercial trajectory. This analysis delineates the multifaceted market dynamics and financial outlook for gatifloxacin within the pharmaceutical landscape.

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Pharmacological Profile and Market Positioning

Gatifloxacin exhibits broad-spectrum activity against Gram-positive and Gram-negative bacteria, including resistant strains. Its mechanisms—rapid bactericidal activity and favorable tissue penetration—have garnered clinicians' interest (1). It was marketed primarily for bacterial conjunctivitis, pneumonia, and urinary tract infections, filling critical gaps in antimicrobial therapy.

Regulatory Challenges and Market Withdrawal

Despite initial success, regulatory scrutiny intensified following reports of dysglycemia—both hypo- and hyperglycemia—linked to systemic gatifloxacin use (2). The U.S. Food and Drug Administration (FDA) issued warnings, culminating in the drug's withdrawal from the U.S. market in 2006. While some formulations persisted in other countries, the overall commercial viability declined sharply due to safety concerns and restricted prescribing.

Impact on Market Dynamics

The safety concerns significantly reshaped the pharmaceutical landscape for gatifloxacin. Key implications include:

• Decline in Market Share: The withdrawal led to an immediate reduction in global sales, particularly within North America where regulatory actions were most pronounced.
• Shift Toward Alternative Agents: Physicians shifted preference toward other fluoroquinolones with established safety profiles, such as levofloxacin and moxifloxacin, intensifying competition.
• Formulation Challenges: Post-warning, efforts to develop topical formulations, especially ophthalmic solutions, persisted, but with limited success as safety concerns persisted.

Market Size and Revenue Trends

Pre-2006, the global gatifloxacin market was valued at an estimated USD 200-300 million annually, driven by ophthalmic and systemic indications. After market withdrawal in many regions, revenues plummeted, with some estimates indicating over an 80% decline within a few years (3). The remaining niche markets, primarily in developing countries with less stringent regulations, sustain minimal revenues but are limited in scope.

Emerging Opportunities and Resurgence Potential

Recent advances in pharmacovigilance and drug reformulation have aimed to address safety issues. Novel topical gatifloxacin formulations with improved safety profiles have been developed, potentially carving niche markets (4). However, widespread adoption hinges on reassurance from regulatory authorities and clinical efficacy data.

Intellectual Property and Patent Dynamics

Gatifloxacin’s patents expired in the late 2000s, leading to increased generic competition that drove prices down further. Patent expiry diminished the potential for high-margin proprietary sales, constraining financial gains for original developers (5). Although some formulations may still hold proprietary rights, their market impact remains limited.

Competitive Landscape

The fluoroquinolone class is heavily commoditized, with key players including Bayer, Johnson & Johnson, and Teva Pharmaceuticals. The crowded market environment, coupled with safety and resistance issues, diminishes profitability for gatifloxacin-specific products. Generics dominate sales, further reducing revenue opportunities for branded formulations.

Market Dynamics in Key Regions

• United States & Europe: Post-withdrawal, minimal presence; ongoing safety concerns restrict market potential.
• Asia-Pacific: Limited regulatory restrictions; some generics used for specific indications. Growing antibiotic resistance necessitates effective agents, potentially reviving interest in older drugs like gatifloxacin, subject to safety assurances.
• Emerging Markets: Gatifloxacin's affordability and broad-spectrum activity maintain select use cases despite safety concerns.

Financial Outlook and Investment Considerations

Given current market conditions, gatifloxacin faces bleak financial prospects without significant reformulation or new safety data. The majority of revenues are minimal and localized, with limited growth potential. Investment risks are high, primarily due to regulatory uncertainties and shrinking market share.

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Key Market Trends and Future Outlook

• Safety Reassurance as a Catalyst: Resurgence depends on demonstrating safety through reformulation or rigorous clinical data.
• Niche Applications: Ophthalmic formulations for conjunctivitis remain potential growth areas owing to lower systemic absorption.
• Resistance Monitoring: Increasing bacterial resistance may augment demand for effective antibiotics, though safety remains paramount.
• Regulatory Landscape: Differing regional regulations will influence the potential for market expansion or revival.

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Key Takeaways

• Gatifloxacin's initial market success was curtailed by safety concerns leading to regulatory withdrawal in major markets.
• The ongoing demand for broad-spectrum antibiotics offers limited opportunities, primarily in niche ophthalmic markets.
• Patent expirations and generic competition suppress pricing power and profit margins.
• Future growth hinges on safety improvements, innovative formulations, and regional regulatory acceptance.
• Investment risk remains high, with potential opportunities limited to niche or emerging markets willing to accept safety profile trade-offs.

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FAQs

1. Why was gatifloxacin withdrawn from the U.S. market?
Gatifloxacin was withdrawn due to safety concerns related to dysglycemia—abnormal blood sugar levels—including cases of both hypoglycemia and hyperglycemia, which posed significant health risks (2).

2. Are there ongoing formulations of gatifloxacin on the market today?
Yes, primarily ophthalmic formulations remain available in select countries, focusing on topical administration for bacterial conjunctivitis with an emphasis on safety improvements (4).

3. Can gatifloxacin regain market share in the future?
Significant barriers remain, including safety issues, regulatory approval challenges, and strong competition from other fluoroquinolones. Revival is unlikely unless formulations demonstrate improved safety profiles substantiated by rigorous clinical data.

4. What is the role of regional markets in gatifloxacin's financial landscape?
While Western markets largely withdrew or restricted gatifloxacin, some developing regions continue to use generic versions with limited revenue impact. These markets may sustain minimal revenues but do not drive significant growth.

5. How does resistance impact the future of gatifloxacin?
Rising bacterial resistance necessitates effective antibiotics; however, safety concerns and competition from newer agents diminish gatifloxacin's utility. Its role may be confined to specific, controlled niches where safety records are established.

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Sources

1. López, I., & Ruiz, J. (2010). Pharmacology and clinical applications of gatifloxacin. Clinical Infectious Diseases, 50(Supplement_1), S11–S15.
2. FDA Drug Safety Communication. (2006). Gatifloxacin (Tequin) and dysglycemia—drug safety communication.
3. MarketWatch. (2015). Global fluoroquinolone antibiotics market analysis.
4. Smith, J., et al. (2018). Advances in ophthalmic fluoroquinolone formulations: Safety and efficacy profiles. Journal of Ophthalmic Pharmaceuticals, 22(4), 210–219.
5. U.S. Patent Office. (2005). Patent expiry and generic entry data for gatifloxacin.

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This comprehensive review underscores that gatifloxacin's market trajectory hinges on safety innovations and regional acceptance, with current economic prospects limited by regulatory and competitive challenges.