TOBRADEX ST Drug Patent Profile

When do Tobradex St patents expire, and what generic alternatives are available?

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. Fifteen 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:	22
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
Umm Al-Qura University	NA
Buddhist Tzu Chi General Hospital	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			Y
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			Y
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes			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

International Patents for TOBRADEX ST

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9203503	COMBINACION DE LA TOBRAMICINA Y LA DEXAMETASONA PARA USO OFTALMICO TOPICO.
Japan	2997202
Denmark	173326

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
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
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727

Market Dynamics and Financial Trajectory for TOBRADEX ST

Last updated: February 20, 2026

What Are the Key Market Factors Influencing TOBRADEX ST?

TOBRADEX ST is a combination ophthalmic drug containing tobramycin and dexamethasone, primarily used for bacterial infections accompanied by inflammation in the eye. Its market viability depends on several factors:

• Market Size: The global ocular antibiotics market was valued at approximately USD 3.3 billion in 2022, growing at a compounded annual growth rate (CAGR) of about 4.5% through 2028 (Grand View Research, 2022).
• Prevalence of Indications: Increasing incidence of bacterial conjunctivitis, postoperative infections, and other ocular inflammations drive demand. U.S. case prevalence for conjunctivitis exceeds 20 million annually (American Academy of Ophthalmology, 2021).
• Competitive Landscape: TOBRADEX ST faces competition from single-agent antibiotics like tobramycin and corticosteroids like dexamethasone, as well as fixed-dose combinations from other manufacturers.
• Regulatory Environment: Approved by FDA, with patent protections extending into the late 2020s. Patent expirations could open market share to generics.
• Pricing and Reimbursement: Pricing varies by region, with premium pricing in the U.S. averaging USD 150–200 per box. Reimbursement policies influence utilization.

How Do Market Trends Shape Financial Potential?

• Rising Eye Disease Incidence: An aging population increases cases requiring ocular anti-infections. The global population aged 60+ is projected to reach 2 billion by 2050, potentially boosting demand.
• Adoption of Combination Therapy: Advancements favor combination drugs like TOBRADEX ST for convenience, leading to higher prescription rates.
• Biosimilars and Generics: Patent expiry anticipated around 2026-2027 may diminish profit margins unless formulations are innovated.
• Competitive Innovation: New formulations, such as sustained-release implants or novel delivery systems, could challenge current market share.

What Are the Financial Trajectories and Revenue Projections?

Year	Estimated Global Sales (USD billions)	Key Growth Drivers
2022	0.25	High prescription rates for conjunctivitis
2023–2025	0.30–0.35	Increased screening, expanding indications
2026–2030	0.50	Patent expirations, introduction of generics

Note: These projections assume stable regulatory approval, continued demand, and no significant price erosion.

What Are the Risks to Financial Performance?

• Patent expiry reduces exclusivity, leading to price competition.
• Emergence of alternative therapies or generic options reduces margins.
• Regulatory changes affecting approval or reimbursement.
• Market saturation in mature regions (e.g., North America, Europe).

How Do Competitive Products Affect the Market?

Product Name	Active Components	Market Position	Price Range (USD) per unit
Tobradex (brand)	Tobramycin + dexamethasone	Market leader in U.S.	150–200
Generic Tobradex	Tobramycin + dexamethasone	Loss of market share for brand, lower price	60–120
Zylet	Loteprednol + tobramycin	Differentiates with a different corticosteroid	120–180

Key Takeaways

• The ophthalmic antibiotic and anti-inflammatory market is expanding, driven by increasing ocular disease prevalence.
• TOBRADEX ST benefits from established efficacy, but faces potential revenue pressure once patents expire.
• Growth forecasts project revenues reaching approximately USD 0.50 billion globally by 2030, subject to patent and market dynamics.
• Competition from generics and innovative delivery methods pose risks to sustained profitability.
• Regulatory and reimbursement policies directly impact market access and revenue streams.

FAQs

1. When are the patents for TOBRADEX ST set to expire?
Patents are anticipated to expire around 2026–2027, opening market opportunities for generics.

2. Can new delivery systems impact TOBRADEX ST's market share?
Yes, sustained-release implants or alternative delivery methods could reduce demand for traditional eye drops.

3. How significant is the impact of generics on revenue?
Generics typically reduce brand-name drug revenue by 30–50% within one to two years after patent expiry.

4. What regions present the highest growth potential?
Emerging markets such as China and India show rapid growth due to increasing ocular health awareness and expanding healthcare infrastructure.

5. Are there any recent regulatory changes that could influence the market?
FDA and EMA approval processes remain stable; however, policy shifts toward biosimilar approval could accelerate generic entry.

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References:

1. Grand View Research. (2022). Ocular Antibiotics Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/ocular-antibiotics-market
2. American Academy of Ophthalmology. (2021). Practice Patterns Survey.
3. FDA. (2023). Approved Ophthalmic Drugs.
4. IMS Health. (2022). Global Prescription Market Data.
5. IQVIA. (2022). Pharmaceutical Market Data and Trends.