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Last Updated: December 22, 2024

Fosfomycin tromethamine - Generic Drug Details


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What are the generic sources for fosfomycin tromethamine and what is the scope of patent protection?

Fosfomycin tromethamine is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Cipla, Xiromed, and Zambon Spa, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for fosfomycin tromethamine. Six suppliers are listed for this compound.

Summary for fosfomycin tromethamine
Drug Prices for fosfomycin tromethamine

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Recent Clinical Trials for fosfomycin tromethamine

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

SponsorPhase
Benova (Tianjin) Innovative medicine Research Co., Ltd.Phase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
SaltroPhase 3

See all fosfomycin tromethamine clinical trials

Medical Subject Heading (MeSH) Categories for fosfomycin tromethamine

US Patents and Regulatory Information for fosfomycin tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiromed FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 212548-001 Oct 6, 2020 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zambon Spa MONUROL fosfomycin tromethamine FOR SOLUTION;ORAL 050717-001 Dec 19, 1996 AA RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 214554-001 Oct 21, 2021 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cipla FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 211881-001 Jan 26, 2022 AA 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

Fosfomycin tromethamine Market Analysis and Financial Projection Experimental

Fosfomycin Tromethamine Market Dynamics and Financial Trajectory

Introduction to Fosfomycin Tromethamine

Fosfomycin tromethamine is an antibiotic used primarily for the treatment of urinary tract infections (UTIs), including lower urinary tract infections and acute cystitis in women. Its unique mechanism of action and effectiveness against multidrug-resistant bacterial strains make it a crucial component in the fight against antibiotic-resistant infections.

Market Size and Growth

The global fosfomycin tromethamine market has been experiencing steady growth over the past few years. As of 2022, the market size was estimated to be around USD 54.93 million[2].

Forecasted Growth

The market is predicted to grow to approximately USD 74.52 million by 2030, with a compound annual growth rate (CAGR) of about 3.92% between 2023 and 2030[2]. Another report suggests a slightly different figure, with the market valued at USD 57.16 million in 2022 and expected to expand at a CAGR of 3.36% during the forecast period[3].

Key Drivers of Market Growth

Increasing Prevalence of UTIs

The rising incidence of urinary tract infections, particularly among women, is a significant driver of the fosfomycin tromethamine market. UTIs are common and can occur in any part of the urinary system, including the ureters, kidneys, urethra, and bladder[2].

Growing Concern Over Antibiotic Resistance

The global concern over antimicrobial resistance (AMR) has highlighted the importance of fosfomycin tromethamine. Its efficacy against multidrug-resistant bacterial strains makes it a strategic solution in combating this growing challenge[5].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure, especially the establishment of new urology centers equipped with the latest technologies and medicines, is another factor driving the market. For instance, the founding of new urology departments in hospitals like Brigham and Women’s Hospital contributes to increased access to medical care for UTIs[2].

Regulatory Approvals

Increasing approvals for the sale of fosfomycin tromethamine in new markets also generate growth opportunities. For example, Xiromed LLC received approvals for launching Fosfomycin Tromethamine Granules for Oral Solution, which is a generic variant of the FDA-approved Monurol®[2].

Market Restraints

Associated Side Effects

Despite its benefits, the fosfomycin tromethamine market faces challenges due to the side effects associated with the medication. Common side effects include headache, nausea, diarrhea, dizziness, and vaginal discomfort. There is also a rare risk of severe intestinal conditions caused by C. difficile bacteria, which can be triggered during or after treatment[2].

Limited Oral Formulations

The limited availability of oral formulations can impact the applicability of fosfomycin tromethamine in scenarios requiring intravenous administration. This limitation can restrict its use in certain clinical settings[5].

Regional Market Analysis

North America

North America is expected to dominate the global fosfomycin tromethamine market during the forecast period. The extensive access to primary medical care, high awareness of UTIs, and increasing healthcare expenditure in the US and Canada are key factors contributing to this dominance[2].

Europe

Europe is also a significant market, driven by the growing female population and increasing incidences of UTIs. Rising awareness programs and high per capita spending capacity further contribute to the market growth in this region[2].

Asia Pacific

The Asia Pacific region is expanding due to rising bacterial illness rates, increased awareness of antibiotic resistance, and the region’s expanding healthcare infrastructure. Fosfomycin tromethamine is gaining popularity as a treatment choice for various bacterial illnesses in this region[5].

Key Players

The global fosfomycin tromethamine market is led by several key players, including:

  • Meiji Seika Pharma
  • Zambon Group
  • CSPC Pharmaceutical Group
  • Sandoz
  • Merck & Co.
  • S.A.L.A.R.S. Pharmaceuticals
  • Pfizer
  • Sanofi
  • Teva Pharmaceutical Industries
  • Bristol Myers Squibb
  • Sun Pharmaceutical Industries
  • North China Pharmaceutical Corporation (NCPC)
  • Mylan
  • GlaxoSmithKline
  • Bayer[2]

Market Segmentation

The market is segmented based on several criteria:

By Application

Fosfomycin tromethamine is primarily used for treating UTIs, including lower urinary tract infections and acute cystitis in women[2].

By Type

The market includes different types such as Fosfomycin Tromethamine Granules for Oral Solution and other formulations[2].

By Geography

The market is segmented into regions such as North America, Europe, Asia Pacific, Latin America, and Middle East and Africa[5].

Financial Trajectory

The financial trajectory of the fosfomycin tromethamine market is positive, driven by the increasing demand for effective treatments against UTIs and antibiotic-resistant infections.

Revenue Projections

The market is expected to grow from USD 54.93 million in 2022 to USD 74.52 million by 2030, indicating a steady increase in revenue over the forecast period[2].

Investment and Research

Growing investments in the launch and construction of new urology centers and ongoing research in UTI detection and treatment are expected to further boost the market's financial performance[2].

Conclusion

The fosfomycin tromethamine market is poised for significant growth driven by the increasing prevalence of UTIs, the growing concern over antibiotic resistance, and expanding healthcare infrastructure. Despite challenges such as side effects and limited oral formulations, the market is expected to deliver higher results due to increasing approvals in new markets and ongoing research.

Key Takeaways

  • The global fosfomycin tromethamine market is expected to grow from USD 54.93 million in 2022 to USD 74.52 million by 2030.
  • The market is driven by the increasing prevalence of UTIs and the growing concern over antibiotic resistance.
  • North America is expected to dominate the market during the forecast period.
  • Key players include major pharmaceutical companies such as Meiji Seika Pharma, Zambon Group, and CSPC Pharmaceutical Group.
  • The market faces challenges due to associated side effects and limited oral formulations.

FAQs

What is the primary use of fosfomycin tromethamine?

Fosfomycin tromethamine is primarily used for the treatment of urinary tract infections (UTIs), including lower urinary tract infections and acute cystitis in women.

Which region is expected to dominate the fosfomycin tromethamine market?

North America is expected to dominate the global fosfomycin tromethamine market during the forecast period due to extensive access to primary medical care and high awareness of UTIs.

What are the key drivers of the fosfomycin tromethamine market?

The key drivers include the increasing prevalence of UTIs, the growing concern over antibiotic resistance, and the expansion of healthcare infrastructure.

What are the common side effects associated with fosfomycin tromethamine?

Common side effects include headache, nausea, diarrhea, dizziness, and vaginal discomfort. There is also a rare risk of severe intestinal conditions caused by C. difficile bacteria.

Which companies are leading the fosfomycin tromethamine market?

Key players include Meiji Seika Pharma, Zambon Group, CSPC Pharmaceutical Group, Sandoz, Merck & Co., and others.

Sources

  1. Cognitivemarketresearch.com: Fosfomycin Trometamol Market Report 2024 (Global Edition)
  2. Zionmarketresearch.com: Fosfomycin Trometamol Market Size, Growth, Share, Demand 2023 ...
  3. Southeast.newschannelnebraska.com: Fosfomycin Trometamol Market Analysis [2024-2032]: Major Players ...
  4. Marketresearchintellect.com: Global fosfomycin market size and forecast
  5. Verifiedmarketresearch.com: In-Depth Industry Outlook: Fosfomycin Market Size, Forecast

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