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. Fourteen 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:	20
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
Buddhist Tzu Chi General Hospital	Early Phase 1
Sutphin Drugs	Early Phase 1
NTC srl	Phase 3

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
Germany	68922688
Japan	H08231405	COMBINATION OF TOBRAMYCIN AND STEROID FOR LOCAL OPHTHALMOLOGICAL APPLICATION
Japan	2997202
Mexico	9203503	COMBINACION DE LA TOBRAMICINA Y LA DEXAMETASONA PARA USO OFTALMICO TOPICO.

Supplementary Protection Certificates for TOBRADEX ST

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

Market Dynamics and Financial Trajectory for TOBRADEX ST

Overview of TOBRADEX ST

TOBRADEX ST, a fixed-dose topical antibiotic and corticosteroid combination, is indicated for steroid-responsive inflammatory ocular conditions where a corticosteroid is necessary and there is a risk or presence of superficial bacterial ocular infection. The product combines tobramycin and dexamethasone, making it a critical treatment for conditions such as blepharitis and conjunctivitis[4].

Market Size and Growth

The global tobramycin eye drop market, which includes TOBRADEX ST, was valued at USD 12.21 billion in 2023 and is projected to reach USD 19.05 billion by 2032, growing at a CAGR of 5.07% from 2024 to 2032. This growth is driven by the increasing demand for effective treatments for bacterial and inflammatory ocular conditions[1].

Product Segmentation

The tobramycin eye drop market is segmented by product type, with TOBRADEX ST falling under the tobramycin and dexamethasone ophthalmic suspension category. This segment is expected to register significant growth due to its efficacy in treating a range of ocular conditions. The tobramycin ophthalmic suspension segment, which includes TOBRADEX ST, accounted for nearly 57% of the global market earnings in 2023 and is anticipated to continue leading the market growth over the next eight years[1].

Application Segmentation

The market is also segmented by application, with the adult segment dominating the market. This is due to the higher incidence of ocular conditions among the adult population. The demand for TOBRADEX ST is expected to remain strong in this segment, driven by the increasing age of the population and the associated rise in ocular health issues[1].

Regional Dynamics

North America is anticipated to register the fastest CAGR in the tobramycin eye drop market, including TOBRADEX ST, due to increased production in countries like the U.S. and a growing aging population. This region is expected to contribute significantly to the global market growth over the forecast period[1].

Clinical Efficacy and Demand

The clinical efficacy of TOBRADEX ST in addressing various eye-related disorders is a key driver of its market growth. The product's ability to prevent infections post-eye injury or surgery and its effectiveness in treating bacterial infections of the eye and eyelids further enhance its demand. Growing digitization and the increased use of electronic equipment, which can lead to eye strain and other ocular issues, also contribute to the market expansion[1].

Industry Challenges

Despite the positive growth trajectory, the market faces challenges such as the adverse effects of the product on the eye and the surge in production costs. The scarce availability of raw materials can also impede the expansion of the global tobramycin eye drop industry, including TOBRADEX ST[1].

Acquisition and Market Impact

Eyevance Pharmaceuticals' acquisition of TOBRADEX ST in 2019 has positioned the product for strong, sustained growth. The acquisition has ensured broad payer coverage and has been praised by medical professionals for its critical role in treating advanced ocular surface diseases.

"Having focused my career on cornea and in particular advanced ocular surface disease, the need for an effective fixed-dose combination of a corticosteroid and antibiotic is critical within my patient population," stated Paul Karpecki, O.D., Director of Cornea at Kentucky Eye Institute in Lexington, Kentucky[4].

Financial Performance

The financial performance of companies involved in the production and distribution of TOBRADEX ST reflects the market's growth potential. For instance, Santen Pharmaceutical, which has products like Tobradex ST and Flarex, has seen significant revenue growth. In their financial reports, Santen highlighted the recovery momentum led by these products, indicating a positive financial trajectory for TOBRADEX ST[2][5].

Key Financial Metrics

• Revenue Growth: The revenue from TOBRADEX ST and similar products has shown a steady increase, with Santen's revenue growing by 7.7% year-over-year in some periods[5].
• Operating Profit: The operating profit margins for these products have been substantial, although they can fluctuate based on strategic investments and other factors. For example, Santen's operating profit has seen variations but generally remains strong[5].
• Market Share: The acquisition by Eyevance and the continued market presence of TOBRADEX ST indicate a strong market share, particularly in the segment of tobramycin and dexamethasone ophthalmic suspensions[4].

Future Outlook

The future outlook for TOBRADEX ST is promising, driven by increasing demand for effective ocular treatments, growing aging populations, and the product's clinical efficacy. However, the industry must navigate challenges related to production costs and raw material availability to sustain long-term growth.

Key Takeaways

• Market Growth: The global tobramycin eye drop market, including TOBRADEX ST, is expected to grow at a CAGR of 5.07% from 2024 to 2032.
• Product Efficacy: The clinical efficacy of TOBRADEX ST in treating bacterial and inflammatory ocular conditions is a significant market driver.
• Regional Dynamics: North America is expected to register the fastest CAGR due to increased production and a growing aging population.
• Challenges: Adverse effects and production costs are potential challenges to the market growth.
• Acquisition Impact: Eyevance Pharmaceuticals' acquisition has positioned TOBRADEX ST for sustained growth.

FAQs

What is TOBRADEX ST used for?

TOBRADEX ST is a fixed-dose topical antibiotic and corticosteroid combination used for treating steroid-responsive inflammatory ocular conditions where there is a risk or presence of superficial bacterial ocular infection.

Who acquired TOBRADEX ST in 2019?

Eyevance Pharmaceuticals acquired TOBRADEX ST in 2019, positioning the product for strong, sustained growth.

What is the projected market size for the global tobramycin eye drop market by 2032?

The global tobramycin eye drop market is projected to reach USD 19.05 billion by 2032.

What are the key drivers of the market growth for TOBRADEX ST?

The key drivers include the clinical efficacy of the product, growing digitization, and the increasing age of the population leading to higher incidence of ocular conditions.

Which region is expected to register the fastest CAGR for the tobramycin eye drop market?

North America is anticipated to register the fastest CAGR due to increased production in countries like the U.S. and a growing aging population.

Sources

1. Zion Market Research: Tobramycin Eye Drop Market Size, Share, Analysis, Growth ...
2. Santen Pharmaceutical: Q2 FY2022 Financial Results
3. AHRQ Healthcare Horizon Scanning System: Status Updates ...
4. PR Newswire: Eyevance Pharmaceuticals Acquires TOBRADEX® ST and ...
5. Santen Pharmaceutical: Financial Results (Core Basis)

Last updated: 2024-12-20