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Last Updated: December 25, 2024

UREX Drug Patent Profile


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Which patents cover Urex, and what generic alternatives are available?

Urex is a drug marketed by Alvogen and is included in one NDA.

The generic ingredient in UREX is methenamine hippurate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Urex

A generic version of UREX was approved as methenamine hippurate by AUROBINDO PHARMA LTD on July 5th, 2016.

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Drug patent expirations by year for UREX

US Patents and Regulatory Information for UREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen UREX methenamine hippurate TABLET;ORAL 016151-001 Approved Prior to Jan 1, 1982 AB 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

UREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hyperuricemia Drugs: A Deep Dive

Introduction

Hyperuricemia, a condition characterized by elevated uric acid levels in the blood, is a precursor to several serious health issues, including gout and kidney stones. The market for hyperuricemia drugs is witnessing significant growth, driven by advancing technologies, increasing prevalence of gout, and improving healthcare infrastructure. Here, we will explore the market dynamics and financial trajectory of hyperuricemia drugs.

Market Size and Growth

The hyperuricemia drugs market was valued at USD 5.08 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.52% from 2024 to 2030, reaching nearly USD 9.00 billion by 2030[1].

Regional Insights

North America

North America dominates the hyperuricemia drugs market, primarily due to the advancement of technology for kidney diseases and the initiatives taken by pharmaceutical organizations to develop novel formulations. Gout, the most common rheumatic disease in adulthood, affects approximately 3.9% of adults in the United States, with over 8 million self-reported cases[1].

Europe and Asia Pacific

Europe and the Asia Pacific region are also significant markets, driven by higher awareness of hyperuricemia and advanced healthcare systems. These regions are expected to contribute substantially to the market growth during the forecast period[1].

Competitive Landscape

The competitive landscape of the hyperuricemia drugs market is dynamic, with several key players investing heavily in research and development.

Key Players and Innovations

  • Bristol Myers Squibb: The FDA has granted Priority Review to Bristol Myers Squibb’s application for Augtyro™, a next-generation tyrosine kinase inhibitor. Although primarily targeted at cancer, such innovations indicate the company's capability to address significant medical needs, which could extend to hyperuricemia treatments[1].

  • UroGen Pharma: UroGen Pharma is ahead of schedule in completing the NDA submission for UGN-102, which has shown promising results in treating low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). This efficiency in regulatory processes could be a model for other pharmaceutical companies in the hyperuricemia market[2].

Segments Covered

The hyperuricemia drugs market is segmented based on several criteria:

By Type

  • Asymptomatic Hyperuricemia
  • Symptomatic Hyperuricemia
  • Others

By Diseases

  • Gout
  • Kidney Stone
  • Others

By Drugs

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
  • Xanthine Oxidase Inhibitors
  • Selective Uric Acid Reabsorption Inhibitor (SURI)
  • Uricosuric Agents
  • Others

By End-User

  • Hospitals
  • Homecare
  • Specialty Clinics
  • Others

Financial Performance and Projections

Revenue Growth

The market revenue is expected to grow significantly, driven by the increasing prevalence of gout and other related diseases. The projected growth from USD 5.08 billion in 2023 to nearly USD 9.00 billion by 2030 underscores the market's potential[1].

Research and Development Expenses

Companies like UroGen Pharma are investing heavily in research and development. For instance, UroGen Pharma reported research and development expenses of $15.4 million in the second quarter of 2024, indicating a commitment to innovation[2].

Operating Expenses and Revenue

The operating expenses for companies in this sector are substantial, but so are the revenues. UroGen Pharma, for example, reported net product revenues of $21.8 million for JELMYTO® in Q2 2024, with total operating expenses of $45.4 million during the same period[2].

Regulatory Environment

FDA Approvals and Priority Reviews

The FDA's granting of Priority Review to drugs like Augtyro™ highlights the regulatory body's support for innovative treatments. This can expedite the approval process for hyperuricemia drugs, benefiting both patients and pharmaceutical companies[1].

Market Drivers

Increasing Prevalence of Gout

Gout is becoming increasingly common, especially among adults. In the United States, it affects 3.9% of adults, with a male-to-female ratio of 3:1.5. This rising prevalence is a significant driver of the market[1].

Advancements in Healthcare Technology

Advancements in technology for kidney diseases and the development of novel drug formulations are key drivers. These innovations improve treatment efficacy and patient outcomes, contributing to market growth[1].

Improving Healthcare Infrastructure

Regions like the Asia Pacific are experiencing improvements in healthcare infrastructure, which increases access to and demand for hyperuricemia treatments. This trend is expected to continue, driving market expansion[4].

Market Challenges

Side Effects and Safety Concerns

Drugs used to treat hyperuricemia can have significant side effects. For example, Augtyro™ has been associated with increased alanine transaminase (ALT) and aspartate aminotransferase (AST) levels in patients. Managing these side effects is a challenge for pharmaceutical companies[1].

Regulatory Hurdles

While Priority Reviews can expedite the approval process, regulatory hurdles remain a challenge. Ensuring compliance with FDA regulations and addressing safety concerns can be time-consuming and costly[1].

Key Takeaways

  • The hyperuricemia drugs market is projected to grow significantly, driven by increasing prevalence of gout and advancements in healthcare technology.
  • North America leads the market, followed by Europe and the Asia Pacific.
  • Key players are investing heavily in research and development, with a focus on innovative treatments.
  • Regulatory support, such as FDA Priority Reviews, is crucial for market growth.
  • Managing side effects and navigating regulatory hurdles are significant challenges.

FAQs

What is the projected market size of the hyperuricemia drugs market by 2030?

The hyperuricemia drugs market is expected to reach nearly USD 9.00 billion by 2030, growing at a CAGR of 8.52% from 2024 to 2030[1].

Which region is expected to lead the global hyperuricemia drugs market?

North America is expected to lead the global hyperuricemia drugs market during the forecast period[1].

What are the main drivers of the hyperuricemia drugs market?

The main drivers include the increasing prevalence of gout, advancements in healthcare technology, and improving healthcare infrastructure[1][4].

What are the common types of drugs used to treat hyperuricemia?

Common types include Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), Xanthine Oxidase Inhibitors, Selective Uric Acid Reabsorption Inhibitor (SURI), and Uricosuric Agents[1].

What are the significant challenges faced by the hyperuricemia drugs market?

Significant challenges include side effects and safety concerns associated with the drugs, as well as regulatory hurdles[1].

Sources

  1. Maximize Market Research: Hyperuricemia Drugs Market: Growth, Size, forecast, Statistics.
  2. UroGen Pharma: UroGen Pharma Ahead of Schedule to Complete UGN-102 NDA Submission and Reports 2024 Second Quarter Financial Results and Business Highlights.
  3. New York University: New York University 2019 Audit Report.
  4. Precedence Research: Cephalosporin Drugs Market Size to Hit USD 26.18 Bn By 2033.

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