METOLAZONE - Generic Drug Details

What are the generic sources for metolazone and what is the scope of freedom to operate?

Metolazone is the generic ingredient in four branded drugs marketed by Gd Searle Llc, Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, Watson Labs, Chartwell Molecular, and I3 Pharms, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for metolazone. Eighteen suppliers are listed for this compound.

Summary for METOLAZONE

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	17
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	24
Patent Applications:	6,347
Drug Prices:	Drug price trends for METOLAZONE
What excipients (inactive ingredients) are in METOLAZONE?	METOLAZONE excipients list
DailyMed Link:	METOLAZONE at DailyMed

See drug prices for METOLAZONE

See drug sales revenues for METOLAZONE

Recent Clinical Trials for METOLAZONE

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

Sponsor	Phase
Johannes Grand	Phase 4
Ospedale Regionale di Lugano	Phase 4
Stadtspital Zürich	Phase 4

See all METOLAZONE clinical trials

Pharmacology for METOLAZONE

Drug Class	Thiazide-like Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for METOLAZONE

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METOLAZONE

C03BA	Sulfonamides, plain
C03B	LOW-CEILING DIURETICS, EXCL. THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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
Chemistry Hlth	METOLAZONE	metolazone	TABLET;ORAL	218606-003	Apr 17, 2024	AB	RX	No	No
Chemistry Hlth	METOLAZONE	metolazone	TABLET;ORAL	218606-002	Apr 17, 2024	AB	RX	No	No
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251-001	Dec 2, 2020	AB	RX	No	No
Micro Labs	METOLAZONE	metolazone	TABLET;ORAL	217563-003	Nov 6, 2024	AB	RX	No	No
Chemistry Hlth	METOLAZONE	metolazone	TABLET;ORAL	218606-001	Apr 17, 2024	AB	RX	No	No
I3 Pharms	ZAROXOLYN	metolazone	TABLET;ORAL	017386-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ne Rx Pharma	METOLAZONE	metolazone	TABLET;ORAL	216216-002	Oct 25, 2022	AB	RX	No	No

Expired US Patents for METOLAZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chartwell Molecular	MYKROX	metolazone	TABLET;ORAL	019532-001	Oct 30, 1987	4,517,179

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