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Last Updated: March 22, 2025

UROPLUS DS Drug Patent Profile


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Which patents cover Uroplus Ds, and what generic alternatives are available?

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

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

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

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 DS clinical trials

US Patents and Regulatory Information for UROPLUS DS

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Shionogi UROPLUS DS sulfamethoxazole; trimethoprim TABLET;ORAL 071816-001 Sep 28, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory of Prescription Drugs: Insights from the U.S. Market

Introduction

The pharmaceutical industry, particularly the market for prescription drugs, is complex and influenced by various factors including competition, regulatory policies, and technological advancements. To understand the market dynamics and financial trajectory of prescription drugs, we will delve into recent trends, competition levels, and financial data.

Competition in Prescription Drug Markets

Overview of Competition

The U.S. prescription drug market is characterized by varying levels of competition, particularly between small molecule drugs and biological products. According to a report by the Assistant Secretary for Planning and Evaluation (ASPE), the number of manufacturers for small molecule drugs has increased, while the market share of these drugs has decreased[1].

Small Molecule Drugs

  • Small molecule drugs, which are traditionally the backbone of the pharmaceutical market, saw a slight increase in expenditures from $359 billion in 2017 to $366 billion in 2022. However, the number of prescriptions for these drugs increased by 19.2% during the same period, indicating a drop in price per prescription[1].

Biological Products

  • Biological products, on the other hand, have seen significant growth. Expenditures on biological products increased by 55% from $163 billion in 2017 to $252 billion in 2022. This growth is driven by higher spending per prescription rather than an increase in the number of prescriptions[1].

Market Share and Expenditures

Shift in Market Share

The market share of small molecule drugs decreased from 69% in 2017 to 59% in 2022, while biological products increased their share. This shift is particularly evident in the specialty drug segment, where biological products now account for a larger share of expenditures despite a smaller number of prescriptions[1].

Specialty Drugs

  • Specialty drug expenditures grew from $226 billion in 2017 to $316 billion in 2022, a 39.9% increase. However, the number of specialty prescriptions decreased by 6.2% during this period, indicating a significant increase in spending per prescription[1].

Financial Trajectory

Spending Trends

The financial trajectory of prescription drugs is heavily influenced by spending trends. For small molecule drugs, the increase in the number of prescriptions has not led to a proportional increase in expenditures, suggesting a decrease in price per prescription. In contrast, biological products have seen a substantial increase in spending due to higher prices per prescription[1].

Impact of Competition

The level of competition affects the financial performance of drug manufacturers. For instance, drugs with only one manufacturer account for a significant share of expenditures. In 2022, 43% of small molecule drugs had a single manufacturer, accounting for 65% of small molecule drug expenditures[1].

Global Pharmaceutical Drug Delivery Market

Market Growth Outlook

The global pharmaceutical drug delivery market is projected to grow from $1,949.4 billion in 2024 to $2,546.0 billion by 2029, driven by a CAGR of 5.5%. This growth is fueled by the rising prevalence of chronic diseases, technological advancements, and government initiatives to provide affordable drug delivery products[3].

Key Drivers

  • Chronic Diseases: The increasing global incidence of chronic diseases such as diabetes, hypertension, and cancer is a significant driver.
  • Technological Advancements: Modernization of drug delivery technologies and patient preference for home-based care are also key factors.
  • Geriatric Population: The growing geriatric population, which is more susceptible to chronic diseases, is another driving force[3].

Challenges and Opportunities

Government Pricing Pressure

One of the major challenges facing the pharmaceutical industry is government pricing pressure. Regulatory bodies impose price caps to increase affordability, which can limit the revenue potential for pharmaceutical companies. This pressure is expected to continue, affecting the profit margins of drug manufacturers[3].

Regional Market Dynamics

North America is anticipated to represent the largest regional market for drug delivery technologies due to favorable reimbursement options, growing awareness of new technologies, and the presence of global pharmaceutical giants[3].

Generic Drug Market Dynamics

Concentration and Competition

The generic drug market is highly concentrated, with 40% of markets supplied by a single manufacturer. The median number of manufacturers per drug market is two, and the share supplied by one or two manufacturers has been increasing. This concentration is due to more exits and fewer entrants, particularly among non-oral drugs[4].

Price and Revenue Trends

Prices of generic drugs are generally falling over time, and increased prices are positively correlated with reduced manufacturer counts. Quarterly sales revenue for a manufacturer-product is relatively small, with a median of less than $10 million[4].

Key Takeaways

  • Competition and Market Share: The U.S. prescription drug market is seeing a shift from small molecule drugs to biological products, with biological products gaining a larger market share.
  • Financial Trends: Spending per prescription is a key driver of increased expenditures, particularly for biological products.
  • Global Market Growth: The global pharmaceutical drug delivery market is expected to grow significantly, driven by chronic diseases, technological advancements, and demographic changes.
  • Challenges: Government pricing pressure and regulatory hurdles are significant challenges for the industry.
  • Regional Dynamics: North America is expected to remain a dominant market due to favorable conditions and the presence of major pharmaceutical companies.

FAQs

What is the current trend in the U.S. prescription drug market?

The U.S. prescription drug market is seeing a shift from small molecule drugs to biological products, with biological products accounting for a growing share of expenditures.

How does competition affect the financial performance of drug manufacturers?

Competition affects the financial performance by influencing prices and market share. Drugs with fewer manufacturers tend to have higher prices and larger market shares.

What are the key drivers of the global pharmaceutical drug delivery market?

The key drivers include the rising prevalence of chronic diseases, technological advancements, government initiatives, and the growing geriatric population.

How does government pricing pressure impact pharmaceutical companies?

Government pricing pressure limits the revenue potential for pharmaceutical companies by imposing price caps, which can reduce their profit margins.

Which region is expected to dominate the pharmaceutical drug delivery market?

North America is anticipated to represent the largest regional market due to favorable reimbursement options, growing awareness of new technologies, and the presence of global pharmaceutical giants.

Sources

  1. ASPE Report: Competition in Prescription Drug Markets, 2017-2022.
  2. Missouri Department of Corrections: Contract Details.
  3. MarketsandMarkets: Pharmaceutical Drug Delivery Market Growth, Drivers & Opportunities.
  4. Duke Health Policy: Identifying the Root Causes of Drug Shortages and Finding Solutions.

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