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Last Updated: December 22, 2024

METOLAZONE Drug Patent Profile


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

Metolazone is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs. and is included in fourteen NDAs.

The generic ingredient in METOLAZONE 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 Metolazone

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

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

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Drug Sales Revenue Trends for METOLAZONE

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Recent Clinical Trials for METOLAZONE

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SponsorPhase
Johannes GrandPhase 4
Stadtspital ZürichPhase 4
Ospedale Regionale di LuganoPhase 4

See all METOLAZONE clinical trials

Pharmacology for METOLAZONE
Drug ClassThiazide-like Diuretic
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for METOLAZONE
Anatomical Therapeutic Chemical (ATC) Classes for METOLAZONE

US Patents and Regulatory Information for METOLAZONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz METOLAZONE metolazone TABLET;ORAL 076732-001 Dec 19, 2003 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roxane METOLAZONE metolazone TABLET;ORAL 076482-002 Apr 29, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz METOLAZONE metolazone TABLET;ORAL 076466-001 Dec 19, 2003 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rubicon METOLAZONE metolazone TABLET;ORAL 215184-001 Aug 20, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic METOLAZONE metolazone TABLET;ORAL 213251-001 Dec 2, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs METOLAZONE metolazone TABLET;ORAL 217563-003 Nov 6, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ne Rx Pharma METOLAZONE metolazone TABLET;ORAL 216216-003 Oct 25, 2022 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

METOLAZONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metolazone

Introduction to Metolazone

Metolazone is a thiazide-like diuretic primarily used to treat congestive heart failure and high blood pressure. It works by decreasing the amount of water reabsorbed into the bloodstream by the kidneys, thereby reducing blood volume and increasing urine volume. This mechanism helps in lowering blood pressure and preventing excess fluid accumulation in heart failure patients[1][5].

Market Growth Drivers

The metolazone market is expected to witness significant growth driven by several key factors:

Rise in Chronic Diseases

The global increase in chronic diseases such as hypertension and heart failure is a major driver. As the prevalence of these conditions rises, so does the demand for effective treatments like metolazone[1][5].

Pharmaceutical R&D

The growth in research and development within the pharmaceutical industry is another significant factor. Innovations in combination therapies and the development of fixed-dose combinations containing metolazone are enhancing its market appeal[5].

Aging Population

The growing aging population is more susceptible to cardiovascular diseases, which in turn increases the demand for metolazone. This demographic shift is a crucial driver of market growth[5].

Affordability

Metolazone is often preferred in cost-conscious healthcare systems due to its affordability compared to newer alternatives. This makes it a viable option for many patients[5].

Market Segmentation

The metolazone market is segmented based on type and application:

Type

  • The market includes various dosages such as 2.5mg, 5mg, and 10mg. The 2.5mg segment has accounted for a noticeable share of the global market and is projected to experience significant growth[4].

Application

  • Metolazone is used to treat edema, mild hypertension, and moderate hypertension. The edema segment is expected to expand at a significant CAGR throughout the forecast period[4].

Competitive Landscape

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

Major Players

  • Companies such as Novartis AG, Teva Pharmaceutical Industries Ltd., Alembic Pharmaceuticals Ltd., Mylan N.V., Lannett, Hikma Pharmaceuticals PLC, UCB S.A., Pfizer Inc., Watson Laboratories, Inc., and Dr. Reddy's Laboratories Ltd. are prominent in the market. These companies are focusing on organic and inorganic growth strategies such as product launches, acquisitions, and partnerships to expand their business and customer base[1][4].

Market Strategies

  • Key players are implementing strategies to strengthen their product portfolios and expand their global market presence. This includes developing new products, entering into partnerships, and acquiring other companies to enhance their market share[1][4].

Financial Trajectory

The financial trajectory of the metolazone market is promising, with several key indicators:

Market Size and Growth Rate

  • The global metolazone market size is expected to grow significantly from 2024 to 2031, with a compound annual growth rate (CAGR) that reflects the increasing demand for the drug[4].

Revenue and Market Share

  • The report provides detailed financial information, including revenue, gross margin, and market share of key players from 2019 to 2023. This data helps in understanding the current market position and future growth prospects[4].

Capital and Operational Expenditure

  • For companies considering setting up a metolazone manufacturing plant, the report provides a detailed analysis of capital expenditure (CapEx) and operational expenditure (OpEx). This includes income projections, taxation, depreciation, and profitability analysis, which are crucial for understanding the financial viability of such projects[5].

Challenges and Restraints

Despite the positive growth outlook, the metolazone market faces several challenges:

Side Effects

  • Side effects such as chest pain or bleeding associated with metolazone consumption can restrain market growth. These adverse effects necessitate careful monitoring and management[1].

Regulatory Scrutiny

  • Regulatory scrutiny and the need for compliance with various regulations can impact market expansion. Companies must navigate these regulatory hurdles to maintain market presence[5].

Generic Competition

  • Generic competition is another challenge. The availability of generic versions of metolazone can reduce the market share of branded products, affecting the financial performance of key players[5].

Geographical Analysis

The metolazone market is analyzed across various regions:

Regional Market Trends

  • The market is segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and South America. Each region has its own market trends, opportunities, and competitive landscape. Understanding these regional dynamics is crucial for developing effective market strategies[1][4].

Technological and Pharmaceutical Trends

The market is influenced by several technological and pharmaceutical trends:

Combination Therapies

  • The development of fixed-dose combinations containing metolazone is a significant trend. This aligns with the broader trend of personalized medicine, where tailored treatments are gaining momentum[5].

Telemedicine and Remote Monitoring

  • The shift towards telemedicine and remote patient monitoring has influenced prescription patterns, indirectly affecting the metolazone market. Doctors are adapting their approaches, which can impact the demand for metolazone[5].

Key Takeaways

  • The metolazone market is driven by the rise in chronic diseases, pharmaceutical R&D, and an aging population.
  • The market is segmented by type (2.5mg, 5mg, 10mg) and application (edema, mild hypertension, moderate hypertension).
  • Key players are focusing on organic and inorganic growth strategies to expand their market presence.
  • The financial trajectory is promising, with significant growth expected from 2024 to 2031.
  • Challenges include side effects, regulatory scrutiny, and generic competition.

FAQs

Q: What is metolazone primarily used for? A: Metolazone is primarily used to treat congestive heart failure and high blood pressure.

Q: Which segment of the metolazone market is expected to grow significantly? A: The 2.5mg segment and the edema application segment are expected to experience significant growth.

Q: Who are the major players in the metolazone market? A: Major players include Novartis AG, Teva Pharmaceutical Industries Ltd., Alembic Pharmaceuticals Ltd., Mylan N.V., Lannett, and others.

Q: What are the key challenges facing the metolazone market? A: Key challenges include side effects, regulatory scrutiny, and generic competition.

Q: How is the shift towards telemedicine affecting the metolazone market? A: The shift towards telemedicine and remote patient monitoring is influencing prescription patterns, which can indirectly affect the demand for metolazone.

Cited Sources

  1. Metolazone Market - Regional And Competitive Landscape - OpenPR
  2. 2019 ACC Expert Consensus Decision Pathway on Risk - JACC
  3. EU Risk Management Plan for Metolazone 5mg Tablets - GOV.UK
  4. Metolazone Market Report 2024 (Global Edition) - Cognitive Market Research
  5. Metolazone Manufacturing Plant Report - IMARC Group

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