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Last Updated: December 22, 2024

TOBREX Drug Patent Profile


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

Tobrex is a drug marketed by Novartis and Sandoz and is included in three NDAs.

The generic ingredient in TOBREX is tobramycin. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tobrex

A generic version of TOBREX was approved as tobramycin by BAUSCH AND LOMB on November 29th, 1993.

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Summary for TOBREX
Drug patent expirations by year for TOBREX
Drug Prices for TOBREX

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Drug Sales Revenue Trends for TOBREX

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Recent Clinical Trials for TOBREX

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

SponsorPhase
Alcon ResearchPhase 1
Alcon ResearchPhase 3

See all TOBREX clinical trials

Pharmacology for TOBREX

US Patents and Regulatory Information for TOBREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TOBREX tobramycin OINTMENT;OPHTHALMIC 050555-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 050541-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 062535-001 Dec 13, 1984 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TOBREX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Viatris Healthcare Limited Tobi Podhaler tobramycin EMEA/H/C/002155
Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2011-07-20
Pari Pharma GmbH Vantobra (previously Tobramycin PARI) tobramycin EMEA/H/C/005086
Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2019-02-18
Pari Pharma GmbH Vantobra tobramycin EMEA/H/C/002633
Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Withdrawn no no no 2015-03-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

TOBREX Market Analysis and Financial Projection Experimental

Tobrex (Tobramycin) Eye Drops: Market Dynamics and Financial Trajectory

Introduction to Tobrex Eye Drops

Tobrex, also known as tobramycin eye drops, is an antibiotic medication used to treat bacterial infections of the eye and eyelids. It is effective in preventing infections post-eye injury or surgery by inhibiting the proliferation of bacteria.

Current Market Size and Growth

As of 2023, the global tobramycin eye drops market was valued at $0.76 billion, with a projected growth to $0.86 billion in 2024, representing a compound annual growth rate (CAGR) of 12.3%[1][3].

Future Growth Projections

The market is anticipated to reach $1.37 billion by 2028, maintaining a CAGR of 12.4% from 2023 to 2028. This robust growth is driven by several key factors:

Expansion into Emerging Markets

The market is expected to expand significantly into emerging markets, particularly in the Asia-Pacific region, where improving healthcare infrastructure and increasing awareness of eye health are driving demand[1].

Advancements in Healthcare Infrastructure

Advancements in healthcare infrastructure, including better diagnostic facilities and increased access to healthcare services, are also contributing to the market's growth[1].

Ongoing Research Efforts

Continuous research efforts aimed at enhancing product formulations and improving the efficacy of tobramycin eye drops are further boosting the market's prospects[1].

Regional Dynamics

North America

North America dominated the tobramycin eye drop market in 2023, driven by a well-established healthcare system and high awareness of eye health among the population[1].

Asia-Pacific

However, the Asia-Pacific region is expected to be the fastest-growing during the forecast period. This growth can be attributed to the surging acceptance of the product among the geriatric population and people residing in hot climatic conditions, as well as the presence of key manufacturers in the region[1][4].

Drivers of Market Growth

Increasing Approvals and Clinical Trials

Increasing approvals for tobramycin eye drops and positive clinical trial outcomes are significant drivers of market growth. These approvals and favorable trial results enhance the credibility and adoption of the product among ophthalmologists[1].

Rising Adoption Among Ophthalmologists

The rising adoption of tobramycin eye drops among ophthalmologists, driven by its established efficacy and safety profile, is another key driver of market growth[1].

Challenges and Restraints

Side Effects

Long-term use of tobramycin eye drops can lead to side effects such as increased risk of antibiotic resistance, allergic reactions, and other adverse effects. These side effects can deter some patients and healthcare providers[3].

Alternative Treatment Options

The development of alternative treatment options for eye infections could potentially reduce the demand for tobramycin eye drops. However, the established efficacy and widespread use of tobramycin are likely to maintain its market position[3].

Financial Projections

Short-Term Projections

By 2028, the market is expected to reach $1.37 billion, with a CAGR of 12.4% from 2023 to 2028[1][3].

Long-Term Projections

Another projection indicates that the market could reach $2.573 billion by 2031, with a CAGR of 14.1% from 2024 to 2031. However, some reports suggest a more conservative growth rate, with the market reaching $19.05 billion by 2032 at a CAGR of 5.07% from 2024 to 2032[3][4].

Impact of Generic Versions

Profit Margins for Generic Manufacturers

The profit margin for generic drug manufacturers, including those producing tobramycin eye drops, is relatively low, around 5%. This contrasts with the higher profit margins of brand-name drug manufacturers, which average over 30%[2].

Authorized Generics

Sometimes, companies release an “authorized generic” version of their brand-name drug to compete with the first generic from another company. This can significantly reduce revenues for the generic company, impacting the market dynamics[2].

Trends Shaping the Market

Telemedicine

The rise of telemedicine is changing how eye care services are delivered, potentially increasing access to tobramycin eye drops and other ophthalmic treatments[1].

Eco-Friendly Practices

There is a growing trend towards eco-friendly practices in the pharmaceutical industry, which could influence the packaging and production of tobramycin eye drops[1].

Combination Therapies

Combination therapies, such as tobramycin/dexamethasone, are becoming more popular, offering a broader therapeutic spectrum and potentially driving market growth[5].

Strategic Partnerships

Strategic partnerships among manufacturers, distributors, and healthcare providers are also shaping the market by improving distribution channels and enhancing product availability[1].

Key Insights

Medical Efficiency

The medical efficiency of tobramycin eye drops in treating bacterial infections of the eye is a significant factor propelling the market's growth. The product's ability to prevent infections post-eye injury or surgery is particularly valuable[4].

Growing Digitization

The rise in the use of electronic equipment in education, work, and recreation activities is contributing to an increase in eye infections, thereby driving the demand for tobramycin eye drops[4].

Regional Market Expansion

Asia-Pacific Dominance

The Asia-Pacific region, which contributed about 60% of the global tobramycin eye drop market revenue in 2023, is expected to continue leading the market. This is due to the surging acceptance of the product among the geriatric population and people residing in hot climatic conditions[4].

North American Growth

The North American market is also set to register significant growth, driven by an increase in the production of tobramycin eye drops in countries like the U.S. and a surge in the aging population[4].

Conclusion

The global tobramycin eye drops market is on a robust growth trajectory, driven by increasing approvals, positive clinical trial outcomes, and rising adoption among ophthalmologists. Despite challenges such as side effects and alternative treatment options, the market's financial outlook remains strong.

Key Takeaways

  • The global tobramycin eye drops market is growing rapidly due to increasing approvals, positive clinical trial outcomes, and rising adoption.
  • The market is expected to reach $1.37 billion by 2028, driven by expansion into emerging markets and advancements in healthcare infrastructure.
  • Trends such as telemedicine, eco-friendly practices, combination therapies, and strategic partnerships are shaping the market.
  • The Asia-Pacific region is expected to be the fastest-growing, while North America continues to be a significant market.

FAQs

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

The global tobramycin eye drops market was valued at $0.76 billion in 2023[1][3].

What is the projected market size of the tobramycin eye drops market by 2028?

The market is anticipated to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[1][3].

Which region is expected to be the fastest-growing for tobramycin eye drops?

The Asia-Pacific region is expected to be the fastest-growing during the forecast period, driven by improving healthcare infrastructure and increasing awareness of eye health[1].

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

The main drivers include increasing approvals, positive clinical trial outcomes, and rising adoption among ophthalmologists, as well as expansion into emerging markets and advancements in healthcare infrastructure[1].

What are the potential challenges facing the tobramycin eye drops market?

Potential challenges include side effects such as antibiotic resistance and allergic reactions, and the development of alternative treatment options for eye infections[3].

Sources

  1. EIN Presswire: Tobramycin Eye Drops Market Segments, Drivers, Restraints, And Trends For 2024-2033.
  2. American Academy of Ophthalmology: The State of Generic Drugs.
  3. Drug Patent Watch: Generic TOBRAMYCIN INN entry, pharmaceutical patent expiry and more.
  4. Zion Market Research: Tobramycin Eye Drop Market Size, Share, Analysis, Growth.
  5. Patsnap: Dexamethasone/Tobramycin - Drug Targets, Indications, Patents.

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