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Last Updated: December 22, 2024

MONUROL Drug Patent Profile


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When do Monurol patents expire, and what generic alternatives are available?

Monurol is a drug marketed by Zambon Spa and is included in one NDA.

The generic ingredient in MONUROL is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Monurol

A generic version of MONUROL was approved as fosfomycin tromethamine by XIROMED on October 6th, 2020.

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

See drug prices for MONUROL

Recent Clinical Trials for MONUROL

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

SponsorPhase
Jordi Gol i Gurina FoundationPhase 4
Balearic Islands Health Service (Ibsalut)Phase 4
Instituto de Investigación Sanitaria AragónPhase 4

See all MONUROL clinical trials

US Patents and Regulatory Information for MONUROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zambon Spa MONUROL fosfomycin tromethamine FOR SOLUTION;ORAL 050717-001 Dec 19, 1996 AA RX Yes Yes ⤷  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

MONUROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosfomycin Trometamol (MONUROL)

Introduction to Fosfomycin Trometamol (MONUROL)

Fosfomycin trometamol, marketed under the brand name MONUROL, is an antibiotic used primarily for the treatment of uncomplicated urinary tract infections (UTIs). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global fosfomycin trometamol market has been experiencing steady growth. As of 2022, the market size was approximately USD 54.93 million. It is projected to grow to around USD 74.52 million by 2030, with a compound annual growth rate (CAGR) of about 3.92% during the forecast period of 2023-2030[1][4].

Regional Dominance

North America is expected to dominate the global fosfomycin trometamol market during the forecast period. This dominance is attributed to the extensive access to primary medical care in the US and Canada, high awareness of UTI infections, and the rising prevalence of UTIs in women. Additionally, the region benefits from increased FDA approvals, growing demand for generic medicines, and rising healthcare expenditure from regional governments[1].

Key Market Drivers

Growing Investments in Urology Centers

The market is driven by growing investments in the launch and construction of new urology centers equipped with the latest technologies and medicines. For instance, the establishment of new departments like the one at Brigham and Women’s Hospital in October 2023 contributes to increased access to medical care for UTIs, particularly among the female population[1].

Increasing Drug Approvals

The market is also boosted by the increasing number of drug approvals in emerging and new markets. The approval of Fosfomycin Tromethamine Granules for Oral Solution by Xiromed LLC in October 2020 is a significant example. This generic variant of Monurol® expands the availability of the drug, contributing to market growth[1].

Research and Innovation

Growing research and innovation in UTI detection and treatment open new avenues for further growth. The development of new diagnostic tools and treatment protocols enhances the efficacy of fosfomycin trometamol, making it a preferred choice for uncomplicated UTIs[1].

Market Segmentation

The global fosfomycin trometamol market is segmented based on application, including postoperative urinary tract infection, common urinary tract infection, preoperative urinary tract infection, and others. The common urinary tract infection segment has seen the highest growth, as fosfomycin trometamol is primarily used for treating uncomplicated or simple UTIs[1].

Key Players

The market is led by several prominent pharmaceutical companies, 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, and Bayer. These companies play a crucial role in driving market growth through their investments in R&D, manufacturing, and distribution[1].

Financial Performance and Challenges

Revenue and Profitability

The financial performance of companies involved in the fosfomycin trometamol market is influenced by several factors. For instance, Mayne Pharma's acquisition of generic products from Teva and Allergan contributed significantly to their revenue, although it faced challenges due to aggressive price competition and rapid generic approvals through the FDA[2].

Regulatory and Market Pressures

The pharmaceutical industry, including the fosfomycin trometamol market, faces significant regulatory and market pressures. Shorter exclusivity periods due to patent challenges and the introduction of generic or biosimilar competitors can lead to a rapid decline in sales for brand-name drugs. This impacts the ability of companies to recoup their R&D investments, as seen in the declining ROI for pharmaceutical R&D in recent years[3].

Side Effects and Usage

Fosfomycin trometamol is generally well-tolerated but can have associated side effects that may restrict market growth. It is crucial for patients to consume the drug only when medically prescribed and to report any persistent side effects to healthcare professionals. The drug typically shows results within 2 to 3 days of treatment[1].

Future Growth Opportunities

Expanding Healthcare Access

The expansion of healthcare access, particularly in emerging markets, presents a significant opportunity for growth. As more care centers for UTIs are established, a higher number of patients will gain access to essential medical care, driving demand for fosfomycin trometamol[1].

Addressing Unmet Medical Needs

The escalating global burden of chronic diseases, including UTIs, fuels the demand for effective treatments like fosfomycin trometamol. Pharmaceutical companies are strategically aligning their R&D investments to address these unmet medical needs, which will shape the future trajectory of healthcare innovation[3].

Balancing Profit and Public Health

The development of antibiotics, including fosfomycin trometamol, must balance profit with public health needs. The emergence of antimicrobial resistance (AMR) and new infectious diseases necessitates increased investment in new antibiotics, despite the significant financial risks and uncertainties involved[3].

Key Takeaways

  • The global fosfomycin trometamol market is projected to grow from USD 54.93 million in 2022 to USD 74.52 million by 2030.
  • North America is expected to dominate the market due to extensive access to primary medical care and high awareness of UTI infections.
  • Growing investments in urology centers, increasing drug approvals, and research innovation are key market drivers.
  • The market is segmented based on application, with the common urinary tract infection segment showing the highest growth.
  • Key players include major pharmaceutical companies investing in R&D and manufacturing.

FAQs

What is the projected market size of fosfomycin trometamol by 2030?

The global fosfomycin trometamol market is projected to grow to around USD 74.52 million by 2030[1].

Which region is expected to dominate the fosfomycin trometamol market?

North America is expected to dominate the global fosfomycin trometamol market during the forecast period[1].

What are the key drivers of the fosfomycin trometamol market?

Key drivers include growing investments in urology centers, increasing drug approvals, and research innovation in UTI detection and treatment[1].

Which segment accounts for the largest share of the fosfomycin trometamol market?

The common urinary tract infection segment accounts for the largest share of the global fosfomycin trometamol market[1].

What are the potential challenges facing the fosfomycin trometamol market?

Challenges include associated side effects, regulatory pressures, and market competition from generic or biosimilar competitors[1][3].

Sources

  1. Zion Market Research: Fosfomycin Trometamol Market Size, Growth, Share, Demand 2023 ...
  2. Mayne Pharma Annual Report 2017: Building our tomorrow - Annual Reports
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research
  4. Cognitivemarketresearch.com: Fosfomycin Trometamol Market Report 2024 (Global Edition)

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