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Last Updated: December 22, 2024

ZAROXOLYN Drug Patent Profile


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When do Zaroxolyn patents expire, and when can generic versions of Zaroxolyn launch?

Zaroxolyn is a drug marketed by I3 Pharms and is included in one NDA.

The generic ingredient in ZAROXOLYN is metolazone. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the metolazone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zaroxolyn

A generic version of ZAROXOLYN was approved as metolazone by SANDOZ on December 19th, 2003.

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Summary for ZAROXOLYN
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 87
Clinical Trials: 7
Patent Applications: 4,058
What excipients (inactive ingredients) are in ZAROXOLYN?ZAROXOLYN excipients list
DailyMed Link:ZAROXOLYN at DailyMed
Drug patent expirations by year for ZAROXOLYN
Recent Clinical Trials for ZAROXOLYN

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

SponsorPhase
University of MarylandPhase 4
University of Maryland, BaltimorePhase 4
University of VirginiaPhase 4

See all ZAROXOLYN clinical trials

US Patents and Regulatory Information for ZAROXOLYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
I3 Pharms ZAROXOLYN metolazone TABLET;ORAL 017386-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
I3 Pharms ZAROXOLYN metolazone TABLET;ORAL 017386-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
I3 Pharms ZAROXOLYN metolazone TABLET;ORAL 017386-003 Approved Prior to Jan 1, 1982 DISCN Yes 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

ZAROXOLYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Zaroxolyn (Metolazone)

Introduction to Zaroxolyn (Metolazone)

Zaroxolyn, known generically as metolazone, is a diuretic medication used primarily to treat hypertension, edema, and chronic kidney disease. Understanding its market dynamics and financial trajectory is crucial for investors, pharmaceutical companies, and healthcare professionals.

Market Growth and Projections

The metolazone market has experienced significant growth in recent years and is expected to continue this trend. From 2023 to 2031, the market is projected to see sustained expansion, driven by increasing demand for effective diuretic treatments[1][4].

Market Segmentation

The metolazone market is segmented based on type (2.5mg, 5mg, and 10mg tablets) and application (hypertension, edema, and chronic kidney disease). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Key Drivers

Several factors drive the growth of the metolazone market:

  • Increasing Prevalence of Hypertension and Edema: The rising incidence of these conditions, particularly in aging populations, increases the demand for diuretic medications like metolazone.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to medications contribute to the market's growth.
  • Competitive Landscape: The presence of multiple pharmaceutical companies, such as Mylan N.V., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd., and others, fosters competition and innovation[1][4].

Market Restraints

Despite the positive outlook, there are several restraints to consider:

  • Regulatory Challenges: Strict regulatory environments and the need for continuous compliance can hinder market growth.
  • Generic Competition: The availability of generic versions of metolazone can reduce the market share of branded products.
  • Side Effects and Safety Concerns: As with any medication, potential side effects and safety concerns can impact patient adherence and market dynamics[1][4].

Financial Performance

The financial performance of metolazone is closely tied to the overall pharmaceutical market and the strategies of key players.

Revenue and Sales

Annual sales of metolazone tablets have been substantial. For example, Teva Pharmaceutical Industries Ltd. reported annual sales of approximately $40 million for the 2.5mg and 10mg strengths of the brand product in 2004[5].

Company Profiles and Strategies

Companies like Teva Pharmaceutical Industries Ltd. and others have diversified product portfolios and strategic partnerships that contribute to their financial stability and growth. For instance, Teva has a robust pipeline of products, including generics and branded medications, which helps in maintaining a strong revenue base[2].

Geographical Performance

The metolazone market performs differently across various geographical regions:

  • North America and Europe: These regions are expected to remain significant markets due to advanced healthcare systems and high demand for diuretic medications.
  • Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Competitive Landscape

The competitive landscape of the metolazone market is characterized by several key players:

  • Teva Pharmaceutical Industries Ltd.: Known for its extensive portfolio of generic and branded medications, including metolazone.
  • Mylan N.V.: Another major player with a strong presence in the global pharmaceutical market.
  • Sandoz International GmbH: A leading generics company that contributes significantly to the metolazone market[1][4].

Innovation and Pipeline

Companies are continuously innovating and expanding their product pipelines. For example, the focus on new product launches, strategic partnerships, and the development of complex products like biosimilars and inhalation drug/device combinations are key strategies adopted by these companies to maintain market competitiveness[2].

Challenges and Opportunities

The metolazone market faces several challenges, including regulatory hurdles and generic competition. However, opportunities abound:

  • Growing Demand: The increasing prevalence of hypertension and edema presents a growing demand for effective treatments.
  • Emerging Markets: Regions like Asia-Pacific offer significant growth opportunities due to their large and growing patient populations[1][4].

PEST Analysis

A PEST analysis (Political, Economic, Social, and Technological) highlights various factors influencing the metolazone market:

  • Political: Regulatory policies and healthcare reforms can significantly impact the market.
  • Economic: Economic stability and healthcare expenditure influence the demand for medications.
  • Social: Increasing awareness about health and wellness drives the demand for diuretic medications.
  • Technological: Advances in pharmaceutical technology and manufacturing processes can enhance product quality and availability[4].

SWOT Analysis

A SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) provides a comprehensive view of the market:

  • Strengths: Diversified product portfolios, strong distribution networks, and brand recognition.
  • Weaknesses: Dependence on a few key products, potential side effects, and regulatory challenges.
  • Opportunities: Growing demand in emerging markets, new product launches, and strategic partnerships.
  • Threats: Generic competition, regulatory changes, and economic downturns[4].

Key Takeaways

  • The metolazone market is expected to see significant growth from 2023 to 2031.
  • Key drivers include increasing prevalence of hypertension and edema, advancements in healthcare, and a competitive landscape.
  • Companies like Teva Pharmaceutical Industries Ltd. and Mylan N.V. play crucial roles in the market.
  • Geographical regions such as North America, Europe, and Asia-Pacific are significant markets.
  • Innovation and pipeline expansion are critical for maintaining market competitiveness.

FAQs

Q: What is the primary use of Zaroxolyn (metolazone)? A: Zaroxolyn (metolazone) is primarily used to treat hypertension, edema, and chronic kidney disease.

Q: Which companies are key players in the metolazone market? A: Key players include Teva Pharmaceutical Industries Ltd., Mylan N.V., Sandoz International GmbH, and others.

Q: What is the projected growth of the metolazone market from 2023 to 2031? A: The market is expected to see sustained significant expansion from 2023 to 2031, driven by increasing demand and other market dynamics.

Q: What are the main segments of the metolazone market? A: The market is segmented based on type (2.5mg, 5mg, and 10mg tablets) and application (hypertension, edema, and chronic kidney disease).

Q: How does the competitive landscape influence the metolazone market? A: The competitive landscape, characterized by multiple pharmaceutical companies, fosters competition and innovation, contributing to market growth.

Cited Sources:

  1. Market Research Intellect - Global Metolazone Sales Market Size, Scope And Forecast Report
  2. Annual Reports - UNITED STATES SECURITIES AND EXCHANGE ... - Annual Reports
  3. Baron Capital Group - A Multi-Billion-Dollar Drug Market
  4. The Insight Partners - Metolazone Market Developments by 2031
  5. Teva Pharmaceutical Industries Ltd. - Teva Announces Approval Of Metolazone Tablets, 2.5 Mg And 10 Mg

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