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Last Updated: December 22, 2024

TOBRAMYCIN SULFATE (PHARMACY BULK) Drug Patent Profile


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When do Tobramycin Sulfate (pharmacy Bulk) patents expire, and what generic alternatives are available?

Tobramycin Sulfate (pharmacy Bulk) is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, and Hospira. and is included in three NDAs.

The generic ingredient in TOBRAMYCIN SULFATE (PHARMACY BULK) is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tobramycin Sulfate (pharmacy Bulk)

A generic version of TOBRAMYCIN SULFATE (PHARMACY BULK) was approved as tobramycin sulfate by HIKMA on April 26th, 1991.

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Summary for TOBRAMYCIN SULFATE (PHARMACY BULK)
Drug patent expirations by year for TOBRAMYCIN SULFATE (PHARMACY BULK)
Recent Clinical Trials for TOBRAMYCIN SULFATE (PHARMACY BULK)

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

SponsorPhase
Madonna Magdy FahmyEarly Phase 1
Osteal Therapeutics, Inc.Phase 2
Joint Purification SystemsPhase 2

See all TOBRAMYCIN SULFATE (PHARMACY BULK) clinical trials

Pharmacology for TOBRAMYCIN SULFATE (PHARMACY BULK)

US Patents and Regulatory Information for TOBRAMYCIN SULFATE (PHARMACY BULK)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 065120-001 Nov 29, 2002 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 209346-001 Feb 9, 2021 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 063116-001 May 18, 1992 DISCN 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

TOBRAMYCIN SULFATE (PHARMACY BULK) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tobramycin Sulfate (Pharmacy Bulk)

Introduction to Tobramycin Sulfate

Tobramycin sulfate is an aminoglycoside antibiotic widely used in various medical applications, including internal medicine, urology, ophthalmology, dermatology, and orthopedics. The drug is available in different forms, such as sterile and non-sterile solutions, and is categorized based on its purity levels.

Current Market Size and Growth

As of the latest reports, the tobramycin sulfate market is experiencing a significant surge. The global market size for tobramycin sulfate is projected to grow substantially from 2023 to 2031. Here are some key figures:

  • The market has seen a rapid and substantial surge in recent years, with projections indicating a sustained and significant expansion from 2023 to 2031[1][4].
  • The global tobramycin eye drops market, a subset of the broader tobramycin sulfate market, was valued at $0.76 billion in 2023 and is expected to reach $0.86 billion in 2024, with a compound annual growth rate (CAGR) of 12.3%[2].

Market Segmentation

The tobramycin sulfate market is segmented based on several criteria:

By Type

  • Sterile and non-sterile solutions
  • Purity levels: Min Purity Less Than 98%, Min Purity 98%-99%, Min Purity More Than 99%[1][4].

By Application

  • Internal Medicine
  • Urology
  • Ophthalmology
  • Dermatology
  • Orthopedics
  • Research and Medical applications[1][4].

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle-East and Africa[1][4].

Market Drivers

Several factors are driving the growth of the tobramycin sulfate market:

Rising Incidence of Infections

The increasing prevalence of bacterial infections, including eye infections such as bacterial keratitis, is a significant driver. As more people are affected by these conditions, the demand for effective treatments like tobramycin sulfate rises[2].

Positive Clinical Trial Outcomes

Positive outcomes from clinical trials have bolstered the confidence of healthcare practitioners and patients in the efficacy of tobramycin sulfate. This has led to increased adoption and prescriptions[2].

Increased Adoption by Healthcare Professionals

Healthcare professionals, particularly ophthalmologists, are increasingly recommending tobramycin sulfate due to its proven effectiveness in treating bacterial infections. This increased adoption is a key factor in market growth[2].

Expansion into Emerging Markets

The market is expected to expand into emerging markets, driven by improving healthcare infrastructure and increasing awareness of health issues. The Asia-Pacific region is anticipated to be the fastest-growing during the forecast period[2].

Market Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Side Effects

Long-term use of tobramycin sulfate 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[2].

Alternative Treatment Options

The development of alternative treatment options for bacterial infections could potentially reduce the demand for tobramycin sulfate. However, the established efficacy and widespread use of tobramycin sulfate are likely to maintain its market position[2].

Economic and Regulatory Hurdles

The development and deployment of antibiotics, including tobramycin sulfate, face significant economic and regulatory hurdles. These include high registration costs, limited volume sales, and low prices, which can make the market less attractive for pharmaceutical companies[3].

Financial Projections

The financial outlook for the tobramycin sulfate market is promising:

  • The global tobramycin eye drops market is expected to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2].
  • Another projection indicates that the broader tobramycin sulfate market could experience robust growth rates throughout the forecast period from 2023 to 2031, driven by the factors mentioned above[1][4].

Regional Dynamics

North America

North America dominated the tobramycin eye drop market in 2023, driven by well-established healthcare infrastructure and high awareness of eye health[2].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing during the forecast period due to improving healthcare infrastructure and increasing awareness of health issues. This growth is driven by expanding economies and a growing middle class with increased access to healthcare services[2].

Key Players

Several key players are active in the tobramycin sulfate market:

  • Xellia Pharmaceuticals
  • Samex Overseas
  • Vibcare Pharma Pvt Ltd
  • TCS
  • AGP Limited (AGP)
  • Integrated Laboratories Pvt Ltd.
  • Salavidas Pharmaceutical Pvt. Ltd.[1]

Market Analysis and Trends

The market analysis involves a mix of quantitative and qualitative approaches, predicting trends from 2023 to 2031. Factors such as product pricing, market penetration, and consumer behavior are taken into account.

Telemedicine and Digital Health

The integration of telemedicine and digital health services is expected to influence the market by improving access to healthcare and enhancing the prescription and delivery of tobramycin sulfate[2].

Eco-Friendly Practices

There is a growing trend towards eco-friendly practices in the pharmaceutical industry, which could impact the production and packaging of tobramycin sulfate[2].

Combination Therapies

Research into combination therapies involving tobramycin sulfate and other antibiotics or treatments is ongoing, which could expand the market by offering more effective treatment options[2].

Strategic Partnerships

Strategic partnerships among pharmaceutical companies and healthcare providers are expected to play a crucial role in driving market growth by enhancing distribution channels and improving access to the drug[2].

Conclusion

The tobramycin sulfate market is poised for significant growth driven by increasing demand for effective treatments against bacterial infections, positive clinical trial outcomes, and expansion into emerging markets. Despite challenges such as side effects and alternative treatment options, the market's financial trajectory remains strong.

Key Takeaways

  • Rapid Market Growth: The tobramycin sulfate market is experiencing a rapid and substantial surge, with projections indicating sustained growth from 2023 to 2031.
  • Market Drivers: Rising incidence of infections, positive clinical trial outcomes, and increased adoption by healthcare professionals are key drivers.
  • Regional Growth: The Asia-Pacific region is expected to be the fastest-growing due to improving healthcare infrastructure.
  • Financial Projections: The market is expected to reach significant values by 2028 and 2031, driven by robust growth rates.
  • Challenges: Side effects and alternative treatment options are challenges that the market faces.

FAQs

What is the current market size of the tobramycin sulfate market?

The global tobramycin eye drops market, a subset of the broader tobramycin sulfate market, was valued at $0.76 billion in 2023[2].

What are the key drivers of the tobramycin sulfate market?

Key drivers include the rising incidence of infections, positive clinical trial outcomes, increased adoption by healthcare professionals, and expansion into emerging markets[2].

Which region is expected to be the fastest-growing in the tobramycin sulfate market?

The Asia-Pacific region is expected to be the fastest-growing during the forecast period due to improving healthcare infrastructure and increasing awareness of health issues[2].

What are some of the challenges facing the tobramycin sulfate market?

Challenges include side effects associated with long-term use and the development of alternative treatment options[2].

What is the projected market size of the tobramycin sulfate market by 2028?

The global tobramycin eye drops market is anticipated to reach $1.37 billion by 2028, with a CAGR of 12.4% from 2023 to 2028[2].

Sources

  1. Market Research Intellect, Tobramycin Sulphate Market Size, Scope And Forecast Report, December 2024.
  2. Drug Patent Watch, Generic TOBRAMYCIN INN entry, pharmaceutical patent expiry and ..., 2023.
  3. Access to Medicine Foundation, Antimicrobial Resistance Benchmark 2018, January 3, 2018.
  4. Market Research Intellect, Tobramycin Sulfate Market Size, Scope And Forecast Report, December 2024.

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