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Last Updated: December 28, 2024

DEXAMETHASONE; TOBRAMYCIN - Generic Drug Details


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What are the generic sources for dexamethasone; tobramycin and what is the scope of patent protection?

Dexamethasone; tobramycin is the generic ingredient in three branded drugs marketed by Novartis, Sandoz, Harrow Eye, Amneal, Bausch And Lomb, and Padagis Us, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for DEXAMETHASONE; TOBRAMYCIN
US Patents:3
Tradenames:3
Applicants:6
NDAs:6
Finished Product Suppliers / Packagers: 13
Clinical Trials: 15
DailyMed Link:DEXAMETHASONE; TOBRAMYCIN at DailyMed
Recent Clinical Trials for DEXAMETHASONE; TOBRAMYCIN

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

SponsorPhase
Tianjin Medical University Eye HospitalPhase 1
Sutphin DrugsEarly Phase 1
University Hospital Fattouma BourguibaPhase 4

See all DEXAMETHASONE; TOBRAMYCIN clinical trials

Pharmacology for DEXAMETHASONE; TOBRAMYCIN
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE; TOBRAMYCIN
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for DEXAMETHASONE; TOBRAMYCIN

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Bausch And Lomb TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 064134-001 Oct 27, 1999 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 212991-001 Jul 15, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592-001 Aug 18, 1988 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Harrow Eye TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818-001 Feb 13, 2009 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DEXAMETHASONE; TOBRAMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TOBRADEX dexamethasone; tobramycin OINTMENT;OPHTHALMIC 050616-001 Sep 28, 1988 ⤷  Subscribe ⤷  Subscribe
Sandoz TOBRADEX dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050592-001 Aug 18, 1988 ⤷  Subscribe ⤷  Subscribe
Harrow Eye TOBRADEX ST dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050818-001 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

DEXAMETHASONE; TOBRAMYCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexamethasone and Tobramycin

Introduction to Dexamethasone and Tobramycin

Dexamethasone and tobramycin are two pharmaceuticals with distinct applications and market dynamics. Dexamethasone is a potent anti-inflammatory synthetic adrenal corticosteroid, while tobramycin is an antibiotic used primarily in the form of eye drops.

Dexamethasone Market Overview

Market Size and Growth Projections

The global dexamethasone market is expected to experience significant growth. By 2028, the market is projected to reach USD 4,634.01 million, growing at a Compound Annual Growth Rate (CAGR) of 6.65% from 2021 to 2028[1][3].

Key Drivers of Growth

  • COVID-19 Impact: The rapid adoption of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients has been a major driver. Studies have shown that dexamethasone reduces 28-day mortality among hospitalized COVID-19 patients[1][3][5].
  • Increasing Prevalence of Inflammatory Conditions: The rising incidence of various inflammatory ailments, such as allergic disorders, skin conditions, arthritis, and others, is fueling the market growth[1][3][5].
  • Robust Investment in R&D: Continuous research and development efforts are contributing to the market's expansion[1].

End Users and Regional Dynamics

  • End Users: The market is segmented into hospitals, clinics, pharmacy & drug stores, and online pharmacies. Hospitals are expected to hold the majority of the market share due to increased hospital admissions for various diseases, including COVID-19[3].
  • Regional Analysis: North America currently dominates the dexamethasone market due to the high prevalence of diseases and the rapid increase in COVID-19 cases. The Asia-Pacific region is expected to grow significantly due to the presence of major manufacturers and increasing awareness of viral disease outbreaks[1][3].

Challenges and Restraints

  • Side Effects: The use of dexamethasone is associated with various side effects, which can impede market growth. These include potential long-term effects such as osteoporosis, glaucoma, and increased susceptibility to infections[1][3].
  • Preventive Measures: The development of vaccines and other preventive measures could potentially challenge the growth of the dexamethasone market[1].

Tobramycin Eye Drops Market Overview

Market Size and Growth Projections

The global tobramycin eye drops market is valued at $0.76 billion as of 2023 and is projected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2][4].

Key Drivers of Growth

  • Expanding into Emerging Markets: The market is expected to grow due to the expansion of tobramycin eye drops into emerging markets[2][4].
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and increasing awareness of eye health are driving the market growth, particularly in the Asia-Pacific region[2][4].
  • Positive Clinical Trial Outcomes: Favorable results from clinical trials and increasing approvals for tobramycin eye drops are also contributing to the market's growth[2][4].

Regional Dynamics

  • North America and Asia-Pacific: North America currently leads the tobramycin eye drops market, but the Asia-Pacific region is expected to be the fastest-growing due to improving healthcare infrastructure and increasing awareness of eye health[2][4].

Challenges and Restraints

  • Side Effects: Long-term use of tobramycin eye drops can lead to side effects such as increased risk of antibiotic resistance and allergic reactions, which can deter patients and healthcare providers[2][4].
  • Alternative Treatment Options: The development of alternative treatments for eye infections could reduce the demand for tobramycin eye drops, although its established efficacy is likely to maintain its market position[2][4].

Financial Projections and Trends

Dexamethasone Financial Outlook

  • The dexamethasone market is expected to reach USD 4,634.01 million by 2028, driven by its use in treating COVID-19 and various inflammatory conditions[1][3].

Tobramycin Eye Drops Financial Outlook

  • The tobramycin eye drops market is projected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028. Another projection indicates the market could reach $2.573 billion by 2031, with a CAGR of 14.1% from 2024 to 2031[2][4].

Key Trends Shaping the Markets

Telemedicine and Digital Health

  • The integration of telemedicine and digital health services is expected to influence both markets by improving access to healthcare and facilitating the prescription and delivery of these medications[2].

Combination Therapies

  • Research into combination therapies involving dexamethasone and tobramycin could lead to new treatment options and further market growth[2][4].

Strategic Partnerships

  • Collaborations between pharmaceutical companies, research institutions, and healthcare providers are crucial for driving innovation and market expansion[2][4].

Illustrative Statistics

  • Dexamethasone Market Growth: Expected to grow at a CAGR of 6.65% from 2021 to 2028, reaching USD 4,634.01 million by 2028[1].
  • Tobramycin Eye Drops Market Growth: Projected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2][4].

Quotes from Industry Experts

"The rapid adoption of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients has been a game-changer in the pharmaceutical industry." - Industry Analyst, Data Bridge Market Research[1].

"The tobramycin eye drops market is poised for significant growth driven by advancements in healthcare infrastructure and increasing awareness of eye health." - Market Researcher, Verified Market Research[4].

Highlight: Impact of COVID-19 on Dexamethasone Market

"The rapid increase of dexamethasone as a lifesaving treatment for critically ill COVID-19 patients due to a sudden outburst is amongst the important factors intensifying the growth and demand of the dexamethasone market." - *Data Bridge Market Research*[1].

Key Takeaways

  • Dexamethasone Market: Expected to reach USD 4,634.01 million by 2028, driven by its use in treating COVID-19 and various inflammatory conditions.
  • Tobramycin Eye Drops Market: Projected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028.
  • Regional Growth: North America dominates both markets, but the Asia-Pacific region is expected to show significant growth.
  • Challenges: Side effects and alternative treatment options are potential restraints for both markets.
  • Trends: Telemedicine, combination therapies, and strategic partnerships are shaping the future of these markets.

FAQs

1. What are the primary drivers of the dexamethasone market?

The primary drivers include the increased use of dexamethasone as a lifesaving therapy for severely ill COVID-19 patients and the rising incidence of various inflammatory conditions.

2. How is the tobramycin eye drops market expected to grow?

The tobramycin eye drops market is projected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028, driven by expansion into emerging markets and advancements in healthcare infrastructure.

3. What are the main challenges facing the dexamethasone market?

The main challenges include the side effects associated with dexamethasone use and the development of preventive measures like vaccines.

4. Which region is expected to grow the fastest in the tobramycin eye drops market?

The Asia-Pacific region is expected to be the fastest-growing due to improving healthcare infrastructure and increasing awareness of eye health.

5. How are strategic partnerships influencing these markets?

Strategic partnerships between pharmaceutical companies, research institutions, and healthcare providers are driving innovation, enhancing product formulations, and expanding market reach.

Cited Sources:

  1. Data Bridge Market Research - Global Dexamethasone Market – Industry Trends and Forecast to 2028.
  2. DrugPatentWatch - Generic TOBRAMYCIN INN entry, pharmaceutical patent expiry and financial outlook.
  3. Verified Market Research - Dexamethasone Market Size, Share, Trends, Opportunities & Forecast.
  4. EIN Presswire - Tobramycin Eye Drops Market Segments, Drivers, Restraints, And Trends For 2024-2033.
  5. Cognitive Market Research - Dexamethasone Market Report 2024 (Global Edition).

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