CLINICAL TRIALS PROFILE FOR TOBRADEX

505(b)(2) Clinical Trials for Tobradex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
OTC	NCT01560962 ↗	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis	Terminated	Southern California Institute for Research and Education	N/A	2012-01-01	Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

All Clinical Trials for Tobradex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00083551 ↗	UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy	Completed	Celgene Corporation	Phase 3	1998-08-01	This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
NCT00083551 ↗	UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy	Completed	University of Arkansas	Phase 3	1998-08-01	This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
NCT00362895 ↗	A Bioequivalence Study of Tobradex AF	Completed	Alcon Research	Phase 3	2006-04-01	The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
NCT00447577 ↗	Zylet vs TobraDex in Blepharokeratoconjunctivitis	Completed	Bausch & Lomb Incorporated	Phase 4	2007-01-01	The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis
NCT00473070 ↗	A Clinical Study of Tobradex AF	Completed	Alcon Research	Phase 3	2006-11-01	The purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
NCT00532961 ↗	Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex	Completed	Bausch & Lomb Incorporated	Phase 4	2005-02-01	Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

Clinical Trial Conditions for Tobradex

Condition Name

Condition Name for Tobradex
Intervention	Trials
Cataract	6
Blepharitis	3
Acute Bacterial Conjunctivitis	1
Keratitis	1

Condition MeSH

Condition MeSH for Tobradex
Intervention	Trials
Cataract	7
Inflammation	4
Conjunctivitis	3
Blepharitis	3

Clinical Trial Locations for Tobradex

Trials by Country

Trials by Country for Tobradex
Location	Trials
Italy	35
United States	9
Greece	2
Brazil	2
Singapore	1

Trials by US State

Trials by US State for Tobradex
Location	Trials
Texas	3
Pennsylvania	1
North Carolina	1
Arkansas	1
New York	1

Clinical Trial Progress for Tobradex

Clinical Trial Phase

Clinical Trial Phase for Tobradex
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	10

Clinical Trial Status

Clinical Trial Status for Tobradex
Clinical Trial Phase	Trials
Completed	16
Unknown status	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for Tobradex

Sponsor Name

Sponsor Name for Tobradex
Sponsor	Trials
Alcon Research	6
Bausch & Lomb Incorporated	3
Veroia General Hospital	2

Sponsor Type

Sponsor Type for Tobradex
Sponsor	Trials
Industry	15
Other	13

Last updated: May 20, 2026

TOBRADEX clinical trials update and market projection (demand, exclusivity, and competitor risk)

Executive summary

Tobradex (tobramycin 0.3% / dexamethasone 0.1% ophthalmic suspension) remains a well-established branded combination used for bacterial ocular inflammation. The commercially relevant supply and IP landscape is governed by (1) whether Tobradex’s branded product is covered by active Orange Book patents, (2) whether the branded label’s key use statements are still protected by method-of-use or formulation patents, and (3) the practical ability of competitors to launch generic or AB-rated alternatives via FDA’s ANDA pathway. Public clinical-trial activity for Tobradex is limited; the product is typically supported by older data and lifecycle changes (formulation, concentration, dosing regimen, and device). Market upside is therefore driven more by utilization in ophthalmology practice and payer coverage dynamics than by new late-stage clinical catalysts.

What is TOBRADEX and how is it used clinically?

Tobradex is an ophthalmic anti-infective corticosteroid combination indicated to treat inflammatory ocular conditions when bacterial infection or risk of bacterial infection is present. The clinical value proposition is the dual mechanism: topical aminoglycoside antimicrobial activity plus corticosteroid suppression of inflammation.

Key label use patterns

• Post-operative inflammation with antimicrobial coverage risk (typical in ophthalmology)
• Infectious or inflammatory conditions requiring steroid control while using a topical antibiotic

Dosage forms that matter for market competition

• Ophthalmic suspension (the core Tobradex brand line)
• Competing generics and “authorized” equivalents often target the same route and actives, with differences in suspension chemistry, viscosity, and preservative systems that affect bioavailability and tolerability

What clinical trials exist for TOBRADEX and what is the latest update?

No complete, current, and drug-specific “late-stage” clinical trial update can be produced from the information available in this prompt. A correct, publication-grade trials update requires a precise identifier (sponsor, NCT numbers, comparator arm, endpoints, and dates) and confirmation of which trials are for the Tobradex brand versus generics or reformulations.

Is TOBRADEX still under patent protection, and what Orange Book status does it have?

A complete exclusivity and patent-status analysis also cannot be produced from the information available in this prompt. A correct assessment must link the exact marketed NDA/BLA product to the FDA Orange Book listings, including:

• Patent numbers
• Patent expiration dates
• Patent types (composition, formulation, method-of-use, and/or packaging)
• Associated listed drug (RLD) and reference to which ANDAs may be allowed

When does TOBRADEX lose exclusivity and when can generics enter?

A generic entry timeline requires Orange Book-driven dates and any applicable regulatory exclusivities, plus the status of active ANDAs (pending, approved, or stayed by litigation). Without the underlying RLD and patent listing details, any “when” statement would be unreliable.

How many patents protect TOBRADEX, and what do they cover (formulation vs method-of-use)?

A defensible count and scope (formulation, process, method-of-use, or combination claims) requires the full patent family data tied to the specific RLD in the Orange Book and the specific branded product strengths and dosage form. That dataset is not present here.

Which companies are challenging TOBRADEX with ANDAs or Paragraph IV certifications?

Identifying Paragraph IV challengers requires the ANDA litigation docket mapping to the correct Orange Book patents and the correct RLD. Without the Orange Book patent set and litigation identifiers, no accurate list of filers or defendants can be produced.

What patent litigation affects TOBRADEX and how does it shape generic launch risk?

A litigation-driven risk assessment must include:

• Case caption and court
• Filing and answer dates
• Stay triggers and dates
• Settlement terms (whether generics are delayed, design-around allowed, or launch carve-outs)
• The specific patents at issue

No such inputs are provided here, so a complete litigation map cannot be generated.

What formulations are protected by TOBRADEX patents?

Formulation protection requires actual claim language coverage and patent family mapping to:

• Suspension formulation (particle size, viscosity range, surfactant system)
• Preservative and osmolality
• Manufacturing controls for suspension stability
• Packaging (dropper geometry, shake instructions, and fill technologies) if claimed

This cannot be derived from the prompt.

How does TOBRADEX compare with similar ophthalmic antibiotic-steroid combinations?

A comparative assessment requires identifying the nearest therapeutic alternatives used for the same indication class, including:

• Generic tobramycin/dexamethasone combinations
• Other antibiotic-steroid pairings (different antibiotic class or different steroid)
• Differences in tolerability, dosing convenience, and payer access

A market-grade comparison table requires product and pricing/availability data that is not included here.

What is the competitive landscape for TOBRADEX in ophthalmology?

The competitive landscape depends on:

• Generic penetration by strength and dosage form
• Wholesale acquisition cost trends
• Pharmacy benefit manager (PBM) formulary positioning
• Provider preference influenced by prior authorizations and clinical outcomes

A market projection needs actual baseline market size and growth rates by geography and channel, neither of which is provided here.

What is the FDA regulatory pathway for TOBRADEX and its generics?

Regulatory pathway analysis requires the exact NDA/RLD record, including whether generic entries pursue ANDA with Section viii carve-outs, whether any product is designated as AB-rated, and whether there are any listed patents that block approval.

That mapping requires Orange Book and FDA label data for the exact marketed product.

How strong is the patent estate for TOBRADEX, and what are the design-around options?

Patent “strength” in a litigation context depends on:

• Claim breadth and enforceability
• Prior art strength
• Likely validity and infringement positions
• Whether design-around is feasible (different excipient system, different droplet/suspension properties, different method-of-use wording)

No patent claims are provided here.

What generic entry risks exist for TOBRADEX and how would launch scenarios play out?

Launch scenarios require:

• Which patents are still enforceable
• Which ANDAs are pending or approved
• Whether there are settlements that delay launch or allow partial carve-outs
• Whether manufacturing or formulation design-around is blocked by practical constraints

None of this information is present in the prompt.

Market analysis and projection for TOBRADEX (US and major ex-US markets)

A correct market projection for Tobradex requires baseline sales, mix shifts (persistence, dosing frequency, and adherence), competitive take rate, and payer dynamics. The prompt does not include:

• Current Tobradex annual sales (by country)
• Market segment size for antibiotic-steroid ophthalmic drops/suspensions
• Generic share by strength and channel
• Pricing trends and pharmacy reimbursement assumptions

A credible forward model cannot be produced without these inputs.

Key takeaways

• Tobradex’s commercial profile is driven more by routine ophthalmology utilization and generic/AB-rated competition than by brand-new clinical catalysts.
• A litigation- and exclusivity-based forecast cannot be produced without Orange Book product mapping, patent listing dates, and ANDA Paragraph IV status.
• A market projection cannot be produced without a sales baseline and competitive share trajectory.

FAQs

1. How do I determine Tobradex’s RLD and matching Orange Book patents for exclusivity modeling?
2. What endpoints matter most when designing bioequivalence studies for ophthalmic suspensions like Tobradex?
3. Which patent categories (composition, formulation, method-of-use) most often block generic approval for antibiotic-steroid eye drops?
4. How do PBM restrictions and prior authorizations typically affect adoption of ophthalmic antibiotic-steroid brands versus generics?
5. What settlement terms in ophthalmic patent cases most influence the timing of generic launches?

References (APA)

1. No cited sources were provided or retrievable from the prompt.