GATIFLOXACIN Drug Patent Profile

When do Gatifloxacin patents expire, and when can generic versions of Gatifloxacin launch?

Gatifloxacin is a drug marketed by Apotex Inc, Caplin, Hikma, Lupin, Rising, and Sandoz. and is included in six NDAs.

The generic ingredient in GATIFLOXACIN is gatifloxacin. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gatifloxacin

A generic version of GATIFLOXACIN was approved as gatifloxacin by SANDOZ on July 11^th, 2016.

Summary for GATIFLOXACIN

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	33
Patent Applications:	4,929
Drug Prices:	Drug price information 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

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
Apotex Inc	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	079084-001	Aug 19, 2011		DISCN	No	No
Lupin	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	202653-001	Aug 28, 2013		DISCN	No	No
Caplin	GATIFLOXACIN	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	213542-001	Nov 3, 2021	AT	RX	No	No

Gatifloxacin Market Dynamics, Financial Trajectory, Generic Competition, and Patent Outlook

Last updated: September 1, 2026

Gatifloxacin is a mature fluoroquinolone with limited commercial value. Its systemic product, Tequin, was withdrawn from the U.S. market in 2006 after safety concerns involving dysglycemia. Ophthalmic gatifloxacin remains commercially available as a generic antibiotic, while branded products such as Zymar and Zymaxid have lost most or all meaningful exclusivity. The market is now driven by low-cost generic supply, institutional purchasing, ophthalmic procedure volumes, and regional regulatory demand rather than innovative pricing.

Public filings do not report gatifloxacin revenue as a standalone product. The financial trajectory is therefore best measured through product withdrawals, generic entry, declining branded exposure, and the absence of material patent barriers.

What is gatifloxacin and which products contain it?

Gatifloxacin is a fourth-generation fluoroquinolone antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. It was developed for systemic and ophthalmic use.

Product	Active ingredient	Formulation	Commercial status
Tequin	Gatifloxacin	Oral tablets and intravenous injection	Withdrawn from the U.S. market in 2006
Zymar	Gatifloxacin 0.3%	Ophthalmic solution	Legacy branded product; generic competition
Zymaxid	Gatifloxacin 0.5%	Ophthalmic solution	FDA-approved branded ophthalmic product; generic competition
Generic gatifloxacin	Gatifloxacin	Primarily ophthalmic solution; selected international oral products	Available in multiple markets, subject to local regulation

The systemic product was associated with abnormal blood-glucose events, including both hypoglycemia and hyperglycemia. The FDA stated that the risks of Tequin outweighed its benefits for the approved indications and announced withdrawal from the U.S. market in 2006.[1]

Ophthalmic gatifloxacin has a different risk profile because ocular dosing produces substantially lower systemic exposure than oral or intravenous administration. Its principal commercial uses have been bacterial conjunctivitis and postoperative ophthalmic infection management.

When did gatifloxacin lose market exclusivity?

Gatifloxacin lost practical market exclusivity in stages rather than on a single date.

Systemic gatifloxacin

The systemic product entered the U.S. market under Bristol-Myers Squibb. Its commercial life was shortened by safety concerns before patent expiry became the primary competitive issue. The FDA’s 2006 withdrawal eliminated Tequin’s U.S. commercial opportunity even though the underlying active ingredient had remaining demand in some international markets.[1]

The product’s systemic patents were based on earlier research and development filings. Patent protection for the active compound and core antibacterial use would have expired before the present period under the standard U.S. patent-term framework, subject to patent-term adjustments, extensions, and jurisdiction-specific rules. No meaningful U.S. systemic exclusivity remains.

Ophthalmic gatifloxacin

Ophthalmic gatifloxacin initially obtained brand protection through product patents, regulatory exclusivity, trademarks, and formulation-related rights. The FDA approved Zymar in 2003 and Zymaxid in 2010.[2][3]

The relevant ophthalmic exclusivity has expired or is no longer commercially effective in the United States. Generic gatifloxacin ophthalmic products are marketed, and the product is treated commercially as an off-patent small molecule. Any remaining country-specific patent rights would not restore broad global pricing power.

What is the FDA regulatory status of gatifloxacin?

The FDA regulatory status differs sharply between systemic and ophthalmic products.

Regulatory issue	Systemic gatifloxacin	Ophthalmic gatifloxacin
U.S. approval	Historically approved as Tequin	Approved as Zymar and Zymaxid
Current U.S. commercial position	Tequin withdrawn	Generic and branded ophthalmic products available historically and currently through approved suppliers
Main safety issue	Dysglycemia and other fluoroquinolone risks	Local ocular tolerability and class-related warnings
FDA pathway	Original NDA	Original NDA followed by ANDA competition
Biosimilar pathway	Not applicable	Not applicable
Primary current competition	Therapeutic substitution and international generic products	Generic ophthalmic solutions and alternative topical antibiotics

The withdrawal of Tequin was a commercial and regulatory endpoint for the systemic franchise. It did not remove ophthalmic gatifloxacin from the market because ophthalmic use was evaluated under a different exposure profile and risk-benefit framework.

FDA labeling for Zymaxid identifies gatifloxacin as a topical ophthalmic antibacterial indicated for bacterial conjunctivitis.[3] Generic products may be approved through the abbreviated new drug application pathway if they demonstrate pharmaceutical equivalence and bioequivalence or meet the applicable ophthalmic requirements.

What patents protect gatifloxacin products?

Current U.S. commercial protection is weak. The core compound, systemic formulation, and principal ophthalmic product rights are mature.

Core compound patents

Core gatifloxacin patents were filed during the original quinolone development cycle. Those rights are now outside their principal commercial life in the United States. They do not create a meaningful barrier to generic ophthalmic supply.

Ophthalmic formulation patents

Ophthalmic products may have relied on patents covering:

• Concentration of gatifloxacin in the ophthalmic solution
• Formulation pH and buffering
• Solubilization and excipient selection
• Preservative systems
• Manufacturing and sterilization processes
• Specific indications or dosing regimens

Formulation patents can delay generic entry when they remain listed in the FDA Orange Book and are enforceable. That mechanism no longer appears to support durable branded pricing for gatifloxacin. The presence of generic products is evidence that any historically relevant blocking rights have expired, been licensed, been circumvented, or ceased to be commercially material.

Orange Book status

The Orange Book is the controlling U.S. source for listed patents and regulatory exclusivity. Historically, branded gatifloxacin ophthalmic products were subject to Orange Book patent and exclusivity analysis. The present commercial market is dominated by generic products, indicating that no active Orange Book listing is preventing broad ANDA competition for the principal ophthalmic presentations.[4]

Patent numbers should be assessed against the current FDA Orange Book rather than historical product labels because listings can be delisted, expire, or change with product ownership.

How many patents cover gatifloxacin today?

No commercially meaningful U.S. patent estate remains for the core gatifloxacin molecule. Historical patents may still appear in global databases or may cover narrow formulations, manufacturing processes, or specific uses in jurisdictions with different filing and term rules.

The practical answer is:

Patent category	Current commercial significance
Core molecule	Low or expired
Systemic formulation	Low following Tequin withdrawal
Ophthalmic formulation	Historically relevant; no longer a broad market barrier
Method of use	Narrow and generally weak against routine generic substitution
Manufacturing process	Potentially relevant for individual suppliers, but not a market-wide barrier
Trademark rights	Brand protection may remain, but does not block generic entry

For investors and generic manufacturers, the key issue is not the number of historical patent documents. It is whether a live, enforceable right blocks an approved generic presentation. For gatifloxacin ophthalmic products, that barrier is generally absent.

Which companies are challenging gatifloxacin exclusivity?

Generic competition has come from multiple manufacturers and private-label suppliers rather than from a single high-profile challenger. Depending on the jurisdiction and period, suppliers have included generic ophthalmic manufacturers, specialty ophthalmology companies, contract manufacturers, and regional pharmaceutical distributors.

The competitive structure is fragmented:

1. Branded originators lost share after generic ophthalmic approvals.
2. Generic manufacturers competed primarily on supply reliability and contract price.
3. Hospitals, clinics, pharmacies, and surgical centers purchased through wholesalers, group purchasing organizations, and regional tenders.
4. International markets continued to support oral or ophthalmic products in jurisdictions where regulatory restrictions and clinical practice differed from the United States.

The market does not have the concentrated challenger profile seen in high-value small-molecule launches. There is no significant biosimilar or authorized-generic event because gatifloxacin is a conventional synthetic small molecule.

What is the financial trajectory for gatifloxacin?

Gatifloxacin’s financial trajectory is characterized by a sharp decline in branded revenue followed by a low-price generic tail.

Revenue phases

Period	Commercial phase	Financial effect
Initial systemic launch	Tequin launched as a branded fluoroquinolone	High branded pricing and sales force support
Safety deterioration	Dysglycemia concerns increased regulatory and physician resistance	Prescription decline and rising risk costs
2006 withdrawal	U.S. systemic product removed	Near-total loss of U.S. systemic revenue
Ophthalmic expansion	Zymar and later Zymaxid supported topical use	Smaller, more specialized branded revenue
Generic entry	ANDA products entered ophthalmic markets	Rapid price erosion and share fragmentation
Current mature market	Generic ophthalmic supply	Low unit prices, limited margin, volume-dependent revenue

Public companies do not generally disclose gatifloxacin sales separately. Bristol-Myers Squibb’s discontinued Tequin business no longer represents a continuing revenue source. Allergan’s ophthalmic portfolio historically included branded gatifloxacin, but the company did not report a standalone gatifloxacin revenue line. Allergan was acquired by AbbVie in 2020, and gatifloxacin is not identified as a material driver of AbbVie’s consolidated revenue.[5][6]

Revenue exposure

The commercial exposure is now concentrated in:

• Generic ophthalmic solution sales
• International formulations
• Hospital and clinic tenders
• Contract manufacturing
• Distribution margins
• Combination or procedure-related ophthalmic demand

The revenue pool is small relative to branded ophthalmology products, injectable anti-infectives, and newer specialty medicines. Gatifloxacin does not have the pricing characteristics required to support major R&D investment or a large commercial organization.

What drives demand for gatifloxacin?

Demand is tied to bacterial eye infections and ophthalmic procedures. The principal market drivers are:

Ophthalmic procedure volumes

Cataract surgery and other ocular procedures can support demand for topical antibiotics. However, gatifloxacin competes with moxifloxacin, ofloxacin, ciprofloxacin, besifloxacin, and combination products. Clinical guidelines and surgeon preference can shift demand among these agents.

Generic price

Low acquisition cost is a major advantage. Pharmacy benefit managers, hospitals, wholesalers, and public-sector procurement organizations generally favor the lowest-cost therapeutically acceptable product.

Antimicrobial stewardship

Fluoroquinolone stewardship can reduce routine use where narrower-spectrum antibiotics are appropriate. In ophthalmology, prescribing decisions also depend on local resistance patterns, postoperative protocols, and the availability of preservative-free or lower-irritation alternatives.

Regional regulation

Some markets continue to sell oral gatifloxacin, although systemic use is restricted or discouraged in many jurisdictions because of dysglycemia and other fluoroquinolone safety concerns. Regulatory divergence creates a fragmented international market rather than a unified global franchise.

How does gatifloxacin compare with moxifloxacin and other ophthalmic antibiotics?

Gatifloxacin competes in a crowded ophthalmic anti-infective category.

Product	Market position	Competitive advantage	Principal limitation
Gatifloxacin	Mature generic ophthalmic antibiotic	Low price and established clinical familiarity	Weak differentiation and limited branded support
Moxifloxacin	Strong ophthalmic generic and branded history	Broad use and strong physician familiarity	Generic price erosion
Ofloxacin	Older low-cost fluoroquinolone	Price and availability	Older molecule and narrower commercial positioning
Ciprofloxacin	Established generic antibiotic	Broad supply and low cost	Formulation and tolerability considerations
Besifloxacin	More differentiated ophthalmic product	Ophthalmic-specific development and positioning	Higher price and branded dependence

Gatifloxacin’s main competitive advantage is cost. It does not have a durable patent or clinical differentiation that supports premium pricing against moxifloxacin or other generic fluoroquinolones.

What generic entry risks exist for gatifloxacin?

Generic entry risk is high because the product is already commercially mature and the main U.S. formulations are available through generic channels.

Generic launch scenarios

The likely scenarios are:

1. Continued low-price supply: Multiple manufacturers maintain ophthalmic availability, with periodic supplier exits and re-entry.
2. Price compression: Additional ANDA approvals or aggressive tendering reduce average selling prices.
3. Shortages from supplier concentration: Low margins can cause manufacturers to leave the market, creating temporary supply disruptions.
4. Therapeutic substitution: Physicians and institutions shift to moxifloxacin, ofloxacin, ciprofloxacin, or non-fluoroquinolone products.
5. Regional persistence: Oral gatifloxacin remains available in selected international markets despite limited U.S. relevance.

Generic risk is therefore less about a future launch event than about ongoing erosion and intermittent supply competition.

What patent litigation affects gatifloxacin?

No major current U.S. patent litigation appears to shape the gatifloxacin market. The product has no active litigation profile comparable with high-value oncology, immunology, or rare-disease drugs.

Historical disputes, if any, would have centered on:

• ANDA Paragraph IV certifications
• Orange Book formulation patents
• Infringement claims involving ophthalmic concentrations
• Settlement terms governing generic launch dates
• Licensing of branded ophthalmic rights

Paragraph IV risk is now largely historical for the core market. A new entrant would more likely face regulatory, manufacturing, quality, and commercial barriers than a high-value patent injunction.

Were there licensing deals or settlement agreements for gatifloxacin?

Gatifloxacin’s original commercial history involved development and commercialization arrangements associated with the originator and ophthalmic product owners. The relevant business relationships changed as products moved from originator control to generic supply.

No publicly material, market-defining current settlement agreement is known to determine U.S. gatifloxacin entry. Any historical settlement would have limited residual value after patent expiry and widespread generic competition.

The most relevant transaction for corporate ownership was AbbVie’s acquisition of Allergan, which transferred Allergan’s ophthalmic portfolio into AbbVie’s business. Gatifloxacin was not a central asset in the transaction.[6]

How strong is the gatifloxacin patent estate?

The patent estate is weak from a current commercial perspective.

Strength factor	Assessment
Core compound protection	Expired or commercially obsolete
Product-specific protection	Mature and no longer sufficient to prevent generic supply
Formulation protection	Potentially narrow; limited current market impact
Method-of-use rights	Weak against routine substitution
Manufacturing rights	Supplier-specific and unlikely to block the market
Regulatory exclusivity	Expired
Biosimilar protection	Not applicable
Litigation leverage	Low
Pricing power	Low

A company evaluating gatifloxacin should treat it as a supply-chain and regulatory-compliance opportunity, not an exclusivity-driven pharmaceutical asset.

What geographic markets still support gatifloxacin?

The United States supports primarily ophthalmic generic use. International markets are more variable.

North America

The U.S. systemic market ended with the withdrawal of Tequin. Ophthalmic products remain the relevant commercial segment, but competition is generic and price-sensitive.

Europe

Systemic fluoroquinolone use is constrained by safety and stewardship policies. Ophthalmic demand may continue through generic products, subject to national reimbursement and authorization decisions.

Asia-Pacific and other emerging markets

Gatifloxacin may have greater commercial persistence in selected countries because of broader generic availability and differing prescribing practices. Oral products may remain marketed in some jurisdictions, but local regulatory restrictions and safety warnings materially affect demand.

Geographic patent coverage

Any remaining patent value must be evaluated country by country. Historical filing families may have different expiration dates, legal status, and enforcement outcomes. No global patent position supports a premium gatifloxacin strategy.

Key Takeaways

• Gatifloxacin is a mature, low-value fluoroquinolone with no meaningful U.S. systemic franchise.
• Bristol-Myers Squibb’s Tequin was withdrawn from the U.S. market in 2006 because of dysglycemia concerns.
• Ophthalmic gatifloxacin remains the commercially relevant segment.
• Zymar and Zymaxid lost practical exclusivity as generic ophthalmic products entered the market.
• The current market has low pricing power, fragmented suppliers, and limited standalone revenue.
• No biosimilar risk exists because gatifloxacin is a synthetic small molecule.
• Patent, Paragraph IV, and litigation risk are low compared with high-value branded medicines.
• The principal business risks are price erosion, therapeutic substitution, manufacturing quality, supplier exits, and regional regulatory restrictions.
• Public-company filings do not provide a reliable standalone gatifloxacin revenue series.
• Commercial upside is limited to efficient generic manufacturing, niche international supply, and dependable ophthalmic distribution.

FAQs

Is gatifloxacin still sold in the United States?

Yes. Ophthalmic gatifloxacin products remain the relevant U.S. category. The systemic product Tequin was withdrawn from the U.S. market in 2006.

Is gatifloxacin more profitable than moxifloxacin?

Generally no. Both products face generic competition, but moxifloxacin has broader market recognition and a larger commercial footprint. Gatifloxacin is usually positioned as a low-cost mature generic.

Can a generic company obtain exclusivity for gatifloxacin today?

A new applicant would not normally obtain meaningful market exclusivity for the old active ingredient. Any exclusivity would depend on a new formulation, delivery system, pediatric indication, or other qualifying regulatory innovation.

Does gatifloxacin have an active Orange Book patent?

The practical market evidence indicates that no Orange Book patent is blocking broad generic ophthalmic competition. Current legal status should be confirmed through the FDA Orange Book for the specific product and dosage form.

Why was oral gatifloxacin withdrawn while eye drops remained available?

Oral dosing produces higher systemic exposure and was associated with clinically significant glucose abnormalities. Ophthalmic dosing produces lower systemic exposure, and the FDA evaluated the topical product under a separate risk-benefit profile.[1][3]

References

1. U.S. Food and Drug Administration. (2006). FDA issues public health advisory on Tequin (gatifloxacin).
2. U.S. Food and Drug Administration. (2003). Zymar ophthalmic solution approval information.
3. U.S. Food and Drug Administration. (2010). Zymaxid (gatifloxacin ophthalmic solution) prescribing information.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
5. Bristol-Myers Squibb Company. (2006). Annual report.
6. AbbVie Inc. (2020). Annual report and Allergan acquisition disclosures.

DrugChatter Q&A for GATIFLOXACIN

Gatifloxacin price?