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Last Updated: December 22, 2024

UROPLUS SS Drug Patent Profile


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

Uroplus Ss is a drug marketed by Shionogi and is included in one NDA.

The generic ingredient in UROPLUS SS is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

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Summary for UROPLUS SS
Drug patent expirations by year for UROPLUS SS
Recent Clinical Trials for UROPLUS SS

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

SponsorPhase
Roswell Park Cancer InstitutePhase 4
National Cancer Institute (NCI)Phase 4
M.D. Anderson Cancer CenterPhase 2

See all UROPLUS SS clinical trials

US Patents and Regulatory Information for UROPLUS SS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi UROPLUS SS sulfamethoxazole; trimethoprim TABLET;ORAL 071815-001 Sep 28, 1987 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

UROPLUS SS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Insights Relevant to UROPLUS SS

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including regulatory changes, technological advancements, and economic conditions. When analyzing the market dynamics and financial trajectory for a specific drug like UROPLUS SS, it is crucial to consider these broader industry trends.

Global Pharmaceutical Market Overview

The global pharmaceutical market is projected to continue its growth trajectory, driven by increasing demand for healthcare services, particularly in emerging markets. According to IQVIA, the global medicine market is expected to grow, with spending projected to increase by $1.1 trillion from 2022 to 2027[1].

Regional Market Dynamics

Europe

The European pharmaceutical market is characterized by fragmentation, which has led to a lucrative but problematic parallel trade. This trade benefits neither social security nor patients and deprives the industry of resources that could be used for R&D. In Europe, especially in the top 5 markets (France, Germany, Italy, Spain, and the UK), spending is expected to increase, but at a slower rate compared to other regions. Regulatory changes, such as the Inflation Reduction Act and new VPAS (Voluntary Pricing and Access Schemes) in the UK, will impact pricing and access to medicines[1][4].

North America

North America, particularly the US, remains a dominant market for pharmaceutical sales. In 2023, North America accounted for 53.3% of global pharmaceutical sales, with 67.1% of new medicines launched during 2018-2023 being introduced in the US market[4].

Emerging Markets

Emerging economies such as Brazil, China, and India are experiencing rapid growth in the pharmaceutical market. These regions are becoming increasingly important for pharmaceutical companies due to their large and growing populations and expanding healthcare systems. For example, Africa is expected to see significant growth, with Egypt leading the prescription growth in the region[1].

Regulatory Environment

Regulatory changes significantly impact the pharmaceutical industry. In Europe, for instance, the GKVFinStG (Gesetz zur Finanzsicherung der gesetzlichen Krankenversicherung) aims to create €17 billion in savings, which includes measures such as price freezes and increased rebates. In the US, the Inflation Reduction Act introduces historic disruptions across stakeholders, affecting pricing and access to medicines[1].

Financial Performance and Investment

Pharmaceutical companies are focusing on optimizing their portfolios and improving financial efficiency. For example, GSK achieved significant financial performance in 2013, with a strong R&D output and substantial returns to shareholders. The company also divested non-core assets to enhance profitability and focus on growth markets[3].

Research and Development (R&D)

R&D is a critical component of the pharmaceutical industry, with companies investing heavily in new medicine development. The sector faces escalating R&D costs, but successful R&D output can lead to significant financial rewards. GSK, for instance, had a highly productive R&D period in 2013, with five out of six major new medicine files being approved[3].

Market Growth Drivers

  • Increasing Demand for Healthcare: Growing populations and aging demographics drive the demand for healthcare services and pharmaceuticals.
  • Technological Advancements: Innovations in drug development, such as biosimilars and personalized medicines, are reshaping the market.
  • Regulatory Changes: Policies like the Inflation Reduction Act and regional pricing regulations impact market dynamics and financial trajectories.
  • Emerging Markets: Rapid growth in regions like Africa, Brazil, China, and India offers new opportunities for pharmaceutical companies[1][4].

Challenges

  • Regulatory Hurdles: Increasing regulatory complexities and austerity measures in Europe pose significant challenges.
  • R&D Costs: Escalating costs associated with drug development and clinical trials are a major concern.
  • Parallel Trade: In Europe, parallel trade diverts resources away from R&D and benefits neither patients nor social security[4].

Financial Trajectory for UROPLUS SS

While specific financial data for UROPLUS SS is not provided, the financial trajectory of such a drug would be influenced by the broader industry trends.

Revenue Potential

  • The revenue potential for UROPLUS SS would depend on its market positioning, competition, and regulatory approvals. In regions with growing healthcare demands and favorable regulatory environments, the drug could see significant revenue growth.
  • Pricing Strategies: The drug's pricing would be influenced by regional regulations and the ability to demonstrate added value compared to existing treatments[1].

Market Penetration

  • Market penetration would be driven by factors such as the drug's efficacy, safety profile, and the ability to secure favorable reimbursement policies.
  • Prescription Trends: The drug's success would also depend on prescription trends, which can be influenced by factors like patient engagement and healthcare provider preferences[1].

Competitive Landscape

  • The competitive landscape in the urology sector would play a crucial role in determining the financial trajectory of UROPLUS SS. The presence of established brands and the emergence of new treatments would impact market share and revenue[4].

Key Takeaways

  • The pharmaceutical industry is driven by complex market dynamics, including regulatory changes, technological advancements, and economic conditions.
  • Emerging markets offer significant growth opportunities, while established markets face challenges such as regulatory hurdles and parallel trade.
  • Successful R&D output and strategic portfolio management are critical for financial performance.
  • The financial trajectory of a drug like UROPLUS SS would be influenced by its market positioning, regulatory approvals, and competitive landscape.

FAQs

Q: What are the key drivers of growth in the global pharmaceutical market? A: The key drivers include increasing demand for healthcare, technological advancements, and growth in emerging markets.

Q: How does the regulatory environment impact pharmaceutical companies? A: Regulatory changes can significantly impact pricing, access, and the overall financial trajectory of pharmaceutical companies.

Q: What role does R&D play in the pharmaceutical industry? A: R&D is crucial for the development of new medicines and can lead to significant financial rewards for companies with successful R&D output.

Q: How does parallel trade affect the pharmaceutical industry in Europe? A: Parallel trade diverts resources away from R&D and benefits neither patients nor social security, posing a significant challenge to the industry.

Q: What factors influence the revenue potential of a new drug like UROPLUS SS? A: The revenue potential is influenced by market positioning, competition, regulatory approvals, and the ability to demonstrate added value compared to existing treatments.

Sources

  1. IQVIA, "The Global Use of Medicines 2023" [PDF].
  2. Surmodics, Inc., "Annual Report on Form 10-K" [PDF].
  3. GSK, "Annual Report 2013" [PDF].
  4. EFPIA, "The Pharmaceutical Industry in Figures 2024" [PDF].

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