Gatifloxacin - Generic Drug Details

What are the generic sources for gatifloxacin and what is the scope of patent protection?

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. Four 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:	4
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
Shaheed Benazir Bhutto University Sheringal Dir Upper	Phase 1
Khyber Medical University Peshawar	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
Rising	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	206446-001	Jun 8, 2018		DISCN	No	No
Apotex Inc	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	079084-001	Aug 19, 2011		DISCN	No	No
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003		DISCN	Yes	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	4,980,470*PED
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548-001	May 18, 2010	6,333,045*PED
Allergan	ZYMAR	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	021493-001	Mar 28, 2003	5,880,283*PED

Market Dynamics and Financial Trajectory for Gatifloxacin

Last updated: February 13, 2026

Gatifloxacin is a fluoroquinolone antibiotic developed by Bayer, introduced in 1999 for ocular infections and later for systemic use. Its market presence has declined due to safety concerns, regulatory withdrawals, and competitive pressures.

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Market Overview and Current Status

Gatifloxacin received approval for ophthalmic use in multiple markets, notably the US and Europe. It was marketed under brands such as Zymaxid (US) and Tequin (systemic use). However, systemic formulations faced significant regulatory restrictions:

• US approval history: Approved in 1999, but withdrawn from the market in 2006 following reports of severe side effects, including dysglycemia.
• European market: It was never introduced officially for systemic use; ophthalmic formulations remained available.

The ophthalmic segment includes prescriptions for bacterial conjunctivitis, with the global market size estimated at around USD 2.3 billion in 2022, expected to grow at approximately 3.7% CAGR through 2030 [1].

Regulatory and Safety Impact

• Systemic use: Gatifloxacin was voluntarily withdrawn from the US market in 2006 due to adverse events linked to blood sugar disturbances, leading to a significant decline in sales and no further approvals for systemic indications.
• Ophthalmic use: Continued approval and sales are limited; some markets have restricted usage due to safety concerns about side effects like corneal deposits.

Market Competitors and Drug Landscape

The ophthalmic fluoroquinolone market is highly competitive, with main players:

• Levofloxacin and moxifloxacin as primary alternatives, which have larger market shares.
• Other antibiotics: Azithromycin, polymyxins, and newer agents.

Gatifloxacin's market share has shrunk, with sales largely substituted by these competitors. The market is characterized by:

• Limited scope for new systemic applications due to safety histories.
• Ongoing use of ophthalmic formulations with minor growth prospects.

Financial Trajectory and Investment Outlook

• Historical revenue: Gatifloxacin's peak systemic sales reached approximately USD 35 million annually before withdrawal.
• Post-withdrawal: Sales ceased in the US for systemic use, and ophthalmic sales diminished due to safety concerns.
• Current revenue status: Minimal, with some residual presence in select markets for ophthalmic indications.

Investment in gatifloxacin's development for new systemic indications is unlikely due to:

• Safety issues and regulatory hurdles.
• Availability of more effective and safer alternatives.

Patent landscape: Gatifloxacin's primary patents have expired by 2014, allowing generic manufacturers to produce off-patent formulations, further reducing revenue potential for original developers.

Market potential: Focus is on reformulations or new delivery mechanisms rather than systemic use. No significant pipeline candidates or phase III trials are publicly disclosed.

Future Outlook

The future of gatifloxacin hinges on:

• Safe reformulation for ophthalmic use.
• Potential niche applications, if safety is demonstrated.
• No significant growth anticipated for systemic indications.

Market analysts forecast a gradual decline in ophthalmic segment revenues unless innovation or safety profile improvements occur.

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Key Takeaways

• The systemic use of gatifloxacin was halted due to safety concerns after 2006; regulatory restrictions remain in place.
• The ophthalmic segment persists but faces competitive pressure, constraining growth.
• Patent expirations and the advent of safer fluoroquinolones limit revenue prospects for gatifloxacin.
• No active pipeline developments suggest limited future investment or adoption.
• The market is driven primarily by alternatives with better safety profiles and efficacy.

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FAQs

1. Why was gatifloxacin withdrawn from the US market?
It was withdrawn due to reports of severe blood sugar disturbances—hypoglycemia and hyperglycemia—linked to systemic use.

2. Can gatifloxacin be used for systemic infections today?
No, regulatory agencies restrict its systemic use. It remains approved only for ophthalmic indications in some markets.

3. Are there ongoing efforts to reformulate gatifloxacin?
Public information indicates limited or no active research on reformulated versions due to safety concerns and patent expirations.

4. What are the main competitors for gatifloxacin in ophthalmology?
Levofloxacin and moxifloxacin dominate the ophthalmic fluoroquinolone market, offering better safety profiles.

5. What is the future market outlook for gatifloxacin?
Market growth is expected to be minimal, focusing on small niche applications or reformulation with safety improvements, if any.

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References

[1] Market research reports on ophthalmologic antibiotics, GlobalData, 2022.