TOBRADEX Drug Patent Profile

Which patents cover Tobradex, and what generic alternatives are available?

Tobradex is a drug marketed by Novartis, Sandoz, and Harrow Eye. and is included in three NDAs. There are three patents protecting this drug.

The generic ingredient in TOBRADEX 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

Indicators of Generic Entry

Summary for TOBRADEX

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	20
Drug Prices:	Drug price information for TOBRADEX
Drug Sales Revenues:	Drug sales revenues for TOBRADEX
What excipients (inactive ingredients) are in TOBRADEX?	TOBRADEX excipients list
DailyMed Link:	TOBRADEX at DailyMed

See drug prices for TOBRADEX

See drug sales revenues for TOBRADEX

Recent Clinical Trials for TOBRADEX

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

Sponsor	Phase
Buddhist Tzu Chi General Hospital	Early Phase 1
Sutphin Drugs	Early Phase 1
NTC srl	Phase 3

See all TOBRADEX clinical trials

Pharmacology for TOBRADEX

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

US Patents and Regulatory Information for TOBRADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988		RX	Yes	Yes
Harrow Eye	TOBRADEX ST	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050818-001	Feb 13, 2009		RX	Yes	Yes	8,101,582		Y
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	AB	RX	Yes	Yes
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	8,450,287		Y

Expired US Patents for TOBRADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TOBRADEX	dexamethasone; tobramycin	OINTMENT;OPHTHALMIC	050616-001	Sep 28, 1988	5,149,694
Sandoz	TOBRADEX	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050592-001	Aug 18, 1988	5,149,694

International Patents for TOBRADEX

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

Country	Patent Number	Title	Estimated Expiration
Germany	365613
Japan	2997202
European Patent Office	0578335
Germany	68922688
European Patent Office	0365613	TOBRAMYCINE ET STEROIDES COMBINES DESTINES A UNE UTILISATION OPHTALMIQUE TOPIQUE. (COMBINATION OF TOBRAMYCIN AND STEROIDS FOR TOPICAL OPHTHALMIC USE.)

Supplementary Protection Certificates for TOBRADEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

TOBRADEX Market Analysis and Financial Projection Experimental

Tobradex Eye Drops: Market Dynamics and Financial Trajectory

Introduction

Tobradex, known generically as tobramycin eye drops, is an antibiotic medication used to treat bacterial infections of the eye and eyelids. This article delves into the market dynamics, growth drivers, and financial trajectory of the tobramycin eye drop market, particularly focusing on Tobradex.

Market Size and Growth Projections

The global tobramycin eye drop market, which includes Tobradex, has been experiencing significant growth. As of 2023, the market size was valued at USD 12.21 billion and is projected to reach USD 19.05 billion by 2032, with a compound annual growth rate (CAGR) of 5.07% from 2024 to 2032[1].

Alternative Projections

Other sources suggest slightly different but still robust growth projections. For instance, the market is estimated to be valued at USD 1,018.9 million in 2024 and is expected to reach USD 2,573.2 million by 2031, exhibiting a CAGR of 14.1% from 2024 to 2031[5].

Key Drivers of Market Growth

Rising Prevalence of Eye Infections

The increasing incidence of eye infections, including bacterial keratitis, is a significant driver of the market. As more people suffer from eye infections, the demand for effective treatments like tobramycin eye drops rises[5].

Growing Digitization and Electronic Use

The rise in the use of electronic equipment for education, work, and recreational activities has led to increased eye strain and a higher risk of eye infections, thereby boosting the demand for tobramycin eye drops[1].

Aging Population

The surge in the aging population globally has resulted in a higher incidence of eye-related disorders, including bacterial infections. This demographic shift is a key factor driving the growth of the tobramycin eye drop market[1].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging markets, have enhanced the accessibility and adoption of tobramycin eye drops. This includes better distribution channels and increased awareness about eye care[3].

Market Segmentation

By Product Type

The tobramycin eye drop market is segmented into tobramycin ophthalmic suspension, tobramycin & dexamethasone ophthalmic suspension, and other tobramycin combination segments. The tobramycin ophthalmic suspension segment dominates the market, accounting for nearly 57% of global market earnings in 2023[1].

By Application

The market is also segmented by application into adult and children segments. The adult segment holds a significant share of the market and is expected to lead the segmental growth due to high demand from the adult population[1].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is a leading market for tobramycin eye drops, contributing about 60% of the global market revenue in 2023. The region's growth is driven by the acceptance of the product among the geriatric population and those living in hot climatic conditions[1].

North America

North America is anticipated to register the fastest CAGR during the forecast period. This growth is attributed to increased production of tobramycin eye drops in countries like the U.S. and the rising aging population in the region[1].

Challenges and Restraints

Adverse Effects

The adverse effects of tobramycin eye drops on the eye can impede market growth. Long-term use of these drops can lead to side effects, which may deter some users and healthcare providers[1][5].

Production Costs and Raw Material Availability

An increase in production costs and the scarce availability of raw materials can also hinder the expansion of the global tobramycin eye drop market[1].

Financial Performance of Key Players

Santen Pharmaceutical

Companies like Santen Pharmaceutical, which produce tobramycin eye drops, have seen varied financial performances. For example, Santen's financial results show fluctuations in operating profit and net profit, influenced by factors such as strategic investments and changes in revenue from different regions[2][4].

Clinical Efficacy and Market Impact

The clinical efficacy of tobramycin eye drops in treating bacterial infections of the eye is a crucial factor in the market's growth. Positive clinical trial outcomes and increasing approvals for these eye drops further support market expansion[3].

Market Opportunities

E-commerce and Awareness

The increasing number of e-commerce websites offering tobramycin eye drops and growing awareness about eye care are expected to provide opportunities for market growth. These factors enhance accessibility and drive consumer demand[5].

Key Takeaways

• The global tobramycin eye drop market is projected to grow significantly, driven by rising eye infections, digitization, and an aging population.
• The Asia-Pacific region is the leading market, while North America is expected to register the fastest CAGR.
• The market faces challenges such as adverse effects and production costs.
• Clinical efficacy and increasing approvals are key drivers of market growth.
• E-commerce and growing awareness about eye care offer additional opportunities for market expansion.

FAQs

What is the current market size of the tobramycin eye drop market?

The global tobramycin eye drop market was valued at USD 12.21 billion in 2023[1].

What is the projected growth rate of the tobramycin eye drop market?

The market is expected to grow at a CAGR of 5.07% from 2024 to 2032[1].

Which region dominates the tobramycin eye drop market?

The Asia-Pacific region contributes about 60% of the global market revenue and is expected to lead the market growth[1].

What are the main drivers of the tobramycin eye drop market?

Key drivers include the rising prevalence of eye infections, growing digitization, and an aging population[1][5].

What challenges does the tobramycin eye drop market face?

The market faces challenges such as adverse effects, increased production costs, and scarce raw material availability[1][5].

Sources

1. Zion Market Research - Tobramycin Eye Drop Market Size, Share, Analysis, Growth.
2. Santen Pharmaceutical - Q2 FY2022 Financial Results.
3. EIN Presswire - Tobramycin Eye Drops Market Segments, Drivers, Restraints, And Trends For 2024-2033.
4. Santen Pharmaceutical - Q3 FY2021 Financial Results.
5. Coherent Market Insights - Global Tobramycin Eye Drop Market Size and Trends.