TOBRADEX ST Drug Patent Profile

Which patents cover Tobradex St, and when can generic versions of Tobradex St launch?

Tobradex St is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.

The generic ingredient in TOBRADEX ST is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

DrugPatentWatch^® Generic Entry Outlook for Tobradex St

Indicators of Generic Entry

Summary for TOBRADEX ST

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	21
Drug Prices:	Drug price information for TOBRADEX ST
What excipients (inactive ingredients) are in TOBRADEX ST?	TOBRADEX ST excipients list
DailyMed Link:	TOBRADEX ST at DailyMed

See drug prices for TOBRADEX ST

Recent Clinical Trials for TOBRADEX ST

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

Sponsor	Phase
Kasr El Aini Hospital	PHASE4
Buddhist Tzu Chi General Hospital	Early Phase 1
Sutphin Drugs	Early Phase 1

See all TOBRADEX ST clinical trials

Pharmacology for TOBRADEX ST

Drug Class	Aminoglycoside Antibacterial Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for TOBRADEX ST

TOBRADEX ST is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	7,795,316		Y
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	8,101,582		Y
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	8,450,287		Y

Expired US Patents for TOBRADEX ST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009	5,149,694

International Patents for TOBRADEX ST

See the table below for patents covering TOBRADEX ST around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0365613	TOBRAMYCINE ET STEROIDES COMBINES DESTINES A UNE UTILISATION OPHTALMIQUE TOPIQUE. (COMBINATION OF TOBRAMYCIN AND STEROIDS FOR TOPICAL OPHTHALMIC USE.)
Denmark	173326
Austria	122564
Japan	H02503439
Japan	2617139
Japan	H08231405	COMBINATION OF TOBRAMYCIN AND STEROID FOR LOCAL OPHTHALMOLOGICAL APPLICATION
European Patent Office	0578335

Supplementary Protection Certificates for TOBRADEX ST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003

Market Dynamics and Financial Trajectory for TOBRADEX ST

Last updated: July 27, 2025

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Introduction

TOBRADEX ST marks a significant segment within ophthalmic treatments, particularly addressing bacterial conjunctivitis and related ocular infections. Comprising a synergistic combination of tobramycin and dexamethasone, this medication offers both antibacterial and anti-inflammatory benefits. Analyzing its market dynamics and financial trajectory requires understanding its clinical positioning, regulatory landscape, competitive environment, and broader healthcare trends propelling its growth.

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Clinical Profile and Pharmacological Advantages

TOBRADEX ST has gained prominence due to its dual-action formulation—tobramycin, an aminoglycoside antibiotic, combats bacterial pathogens, while dexamethasone, a corticosteroid, mitigates inflammation. The 'ST' formulation enhances ocular surface penetration, ensuring rapid therapeutic effects. Its efficacy, combined with a favorable safety profile when used appropriately, makes it a preferred treatment in acute infectious ocular conditions.

The clinical superiority over monotherapies underscores its sustained demand among ophthalmologists. Moreover, the convenience of a single topical drop regimen improves patient compliance, further entrenching its market position.

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Market Landscape and Key Players

Market Size and Growth Drivers

The global ophthalmic pharmaceutical market is poised for robust expansion, projected to reach USD 38.7 billion by 2027, growing at a CAGR of approximately 4.9% from 2020 to 2027 (Grand View Research). Segment-specific drivers include rising prevalence of eye infections, increased awareness of ocular health, and technological advancements in drug delivery.

Within this landscape, ophthalmic steroid-antibiotic combinations—like TOBRADEX ST—constitute a lucrative niche due to their clinical efficacy and convenience. The demand for such combination therapies is bolstered by the rising incidence of bacterial conjunctivitis, especially in developing regions where ocular hygiene practices are evolving.

Regulatory and Market Access Factors

Regulatory approvals across major markets—FDA in the United States and EMA in Europe—enhance market access. Patent protection offers competitive advantages, although expiration dates and subsequent biosimilar/copy formulations threaten market share.

In certain jurisdictions, off-label prescribing and local formularies influence prescribing patterns, impacting revenue streams. The increasing focus on cost-effective therapies incentivizes payers to favor generic options, intensifying price competition.

Distribution Channels and Geographic Trends

Emerging markets, notably in Asia-Pacific, represent significant growth corridors, driven by expanding healthcare infrastructure and increased ophthalmic care access. In mature markets, emphasis on outpatient care and pharmacy-based sales sustain revenue streams.

The rise of e-prescriptions and digital health tools further streamline distribution, augmenting availability.

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Competitive Dynamics

Established Competitors

Key competitors include other fixed-dose combination ophthalmics, such as Maxitrol (neomycin, polymyxin B, dexamethasone) and generic formulations containing tobramycin/dexamethasone. These alternatives exert pressure on pricing and market share.

Innovative and Pipeline Developments

Innovation in drug delivery systems—such as sustained-release implants and nanotechnology-based formulations—could reshape the competitive landscape. Additionally, the advent of preservative-free formulations aligns with the increasing emphasis on ocular surface health, potentially reducing reliance on traditional solutions.

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Financial Trajectory and Revenue Projections

Historical Performance

While specific sales data for TOBRADEX ST remains proprietary, generic and branded ophthalmic combination products have demonstrated steady growth, aligning with overall ophthalmic market trends.

Forecasting Market Revenue

Applying growth assumptions derived from broader ophthalmic trends, TOBRADEX ST's revenue is projected to grow at a CAGR of 3-5% over the next five years, contingent on key factors:

• Patent Lifespan and Patent Expiry: Loss of exclusivity could precipitate decline unless offset by new formulations or indications.
• Regulatory Approvals: Enhanced approvals or expanded indications can expand market penetration.
• Pricing Strategies: Adjustments in pricing, especially in emerging markets, influence overall revenue.

Impact of Biosimilars and Generics

Generic competition typically leads to significant price erosion within 12-24 months post-patent expiry, reducing profitability and sales volume. Companies may counteract this through value-added services, patient support programs, or drug delivery innovations.

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Regulatory and Reimbursement Landscape

Differences in reimbursement policies across regions heavily influence financial trajectories. Countries with comprehensive coverage for ophthalmic therapies promote higher adoption rates. Conversely, reimbursement hurdles can suppress demand, especially for premium formulations.

Regulatory bodies' policies toward generic substitution and formulary inclusion are pivotal; favorable positioning can accelerate revenue growth.

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Market Challenges and Opportunities

Challenges:

• Price erosion due to generics
• Stringent regulatory pathways for new formulations
• Competition from novel therapeutics or biologics
• Prescribing conservatism reducing immediate uptake

Opportunities:

• Expansion into untapped geographic markets
• Development of preservative-free or sustained-release versions
• Incorporation of digital health monitoring for adherence
• Strategic collaborations to penetrate emerging markets more rapidly

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Key Takeaways

• The market for TOBRADEX ST is driven by its clinical efficacy, convenience, and ongoing demand for effective ocular infection treatments.
• Regulatory approvals and patent exclusivity play pivotal roles in shaping revenue trajectories, with expiration timelines threatening revenue streams.
• Emerging geographic markets provide significant growth opportunities, especially as healthcare access improves.
• Intensified competition from generics and biosimilars could compress margins unless offset by product differentiation strategies.
• Innovation and formulation advancements represent promising avenues to sustain and enhance the drug’s market position and financial returns.

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FAQs

1. What factors influence the market growth of TOBRADEX ST?
   Clinical demand, patent status, regulatory approvals, competitive landscape, and regional healthcare infrastructure are primary influences.

2. How does generic competition impact the financial trajectory of TOBRADEX ST?
   Generics typically lead to price reductions and market share erosion post-patent expiry, temporarily dampening revenue unless compensated by increased volume or new formulations.

3. Are there upcoming regulatory challenges for TOBRADEX ST?
   Potential challenges include obtaining approvals for new formulations, addressing safety concerns, and navigating local regulatory policies that influence market access.

4. What role do emerging markets play in the future of TOBRADEX ST?
   These markets exhibit high growth potential due to increasing prevalence of ocular infections, expanding healthcare infrastructure, and rising awareness.

5. What strategic areas can pharmaceutical companies explore to enhance TOBRADEX ST’s market share?
   Investment in innovative delivery systems, expanding indications, improving patient adherence, and forming strategic collaborations to penetrate new markets.

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References

1. Grand View Research. (2022). Ophthalmic Drugs Market Size, Share & Trends Analysis Report By Product, By Application, By Region, And Segment Forecasts, 2020 - 2027.
2. US Food and Drug Administration (FDA). (2021). Guidance Documents on Ophthalmic Drug Development and Approval.
3. European Medicines Agency (EMA). (2022). Regulatory Framework for Ophthalmic Medicines.
4. MarketWatch. (2022). Opthalmic Drugs Market Analysis and Trends.
5. Company Annual Reports & Public Disclosures.

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In conclusion, the financial and market prospects for TOBRADEX ST hinge on strategic management of patent life cycles, ongoing clinical demand, and innovation investments. As the specialty ophthalmic market evolves, adaptive strategies rooted in regional expansion, formulation advancements, and competitive differentiation will be vital for sustaining growth and profitability.