METOLAZONE Drug Patent Profile

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

Metolazone is a drug marketed by Alembic, Ani Pharms, Innogenix, Ixora Lifescience, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon Research, Sandoz, Unichem, 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. Nineteen 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 19^th, 2003.

Summary for METOLAZONE

US Patents:	0
Applicants:	13
NDAs:	14
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	26
Patent Applications:	4,469
Drug Prices:	Drug price information 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
Cairo University	PHASE4
National Heart Institute, Egypt	PHASE4
Clinica Alemana de Santiago	NA

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
Unichem	METOLAZONE	metolazone	TABLET;ORAL	214799-001	Mar 30, 2021	AB	RX	No	No
Rubicon Research	METOLAZONE	metolazone	TABLET;ORAL	215184-003	Aug 20, 2021	AB	RX	No	No
Unichem	METOLAZONE	metolazone	TABLET;ORAL	214799-002	Mar 30, 2021	AB	RX	No	No
Sandoz	METOLAZONE	metolazone	TABLET;ORAL	076732-001	Dec 19, 2003	AB	RX	No	No
Alembic	METOLAZONE	metolazone	TABLET;ORAL	213251-001	Dec 2, 2020	AB	RX	No	No
Mylan	METOLAZONE	metolazone	TABLET;ORAL	076698-003	Oct 19, 2004	AB	RX	No	No
Renata	METOLAZONE	metolazone	TABLET;ORAL	215616-003	Oct 24, 2022	AB	RX	No	No

Last updated: February 13, 2026

What Are the Market Dynamics for Metolazone?

Metolazone is a thiazide-like diuretic primarily used to treat hypertension and edema. Its market is influenced by factors including patent status, competition, and regulatory environment.

Market Size and Growth Trends

The global diuretics market, which includes metolazone, was valued at approximately $2.4 billion in 2022, with a compound annual growth rate (CAGR) of around 3.2% projected from 2023 to 2030[1]. Metolazone accounts for roughly 15% of this segment, owing to its specific use cases in resistant hypertension and edema management.

Market Drivers

• Increasing prevalence of hypertension and heart failure: The rising burden of cardiovascular diseases elevates demand for diuretics.
• Off-label use and combination therapies: Metolazone is often used in combination with other antihypertensives for resistant cases.
• Patent expirations: Several patents on competing drugs have expired, influencing prescribing patterns toward older agents like metolazone.

Market Challenges

• Availability of generic alternatives: Generic formulations have substantially reduced the drug’s price, impacting revenue.
• Regulatory concerns: Safety profile concerns, particularly electrolyte disturbances, can restrict usage.
• Competition from newer agents: Drugs like indapamide and chlorthalidone offer similar efficacy with differing side effect profiles.

Regional Market Variability

• North America: Dominates the market with advanced healthcare infrastructure and high diagnosis rates for hypertension.
• Europe: Maintains steady demand with increasing adoption due to aging populations.
• Asia-Pacific: Exhibits rapid growth driven by rising hypertension prevalence and expanding healthcare access.

What Is the Financial Trajectory for Metolazone?

Financial data for metolazone is largely derived from revenue figures reported by pharmaceutical companies holding marketing rights, considering the drug's generic status.

Revenue and Sales Trends

• Historical sales in the US: Peak sales exceeded $50 million annually in the early 2000s before generic competition eroded market share.
• Current sales: Estimated at less than $20 million globally, mainly from generic suppliers.
• Impact of generics: Price erosion has caused revenues to decline by an average of 15-20% annually over the past decade.

Pricing Dynamics

• Original branded formulations: Priced around $150-$200 per month.
• Generic versions: Available at approximately $10-$20 per month, leading to significant price compression.
• Reimbursement patterns: Insurance coverage favors generics, further reducing revenue potential.

Investment Flows and R&D

• Minimal investment is directed toward metolazone R&D due to its age and patent expirations.
• Companies focus R&D efforts on novel diuretics with improved safety profiles or delivery methods.

Outlook and Future Revenue Potential

• Limited growth prospects unless new formulations or combination therapies are introduced.
• The resurgence of interest in thiazide-like diuretics in resistant hypertension could sustain some demand.
• Regulatory restrictions or safety concerns could further constrain the market.

How Do Regulatory and Patent Factors Influence the Market?

• Several patents on formulations and manufacturing processes expired around 2010-2015.
• Regulatory agencies have issued warnings on electrolyte imbalances associated with thiazide diuretics.
• Nations with stringent drug safety regulations (e.g., US, EU) influence formulary decisions.

Summary Table: Market and Financial Overview

Aspect	Details
Market size (2022)	~$2.4 billion (diuretics segment)
Market growth rate (2023-2030)	3.2% CAGR
Metolazone share	15% of diuretics market
Revenue (current estimate)	<$20 million globally, declining due to generics
Price (branded)	$150-$200/month
Price (generic)	$10-$20/month
Patent status	Expired by 2015
Major regions	North America, Europe, Asia-Pacific

Key Takeaways

• Metolazone operates in a mature market with slow but steady growth driven by cardiovascular disease prevalence.
• Revenue prospects are limited by generic competition, with declining sales observed over the past decade.
• Future market expansion hinges on clinical shifts toward combination therapies and potential new formulations.
• Regulatory safety concerns and patent expirations have historically reduced profitability.
• Regional demands, especially in emerging markets, offer some opportunities for demand stability.

Five FAQs

1. What conditions is metolazone primarily prescribed for?
   It treats hypertension, edema, and cases resistant to other diuretics.

2. How does metolazone compare to other diuretics?
   It provides potent diuresis with a longer duration than some other thiazides but has a similar safety profile.

3. What is the impact of patent expiration on metolazone’s market?
   The expiration has led to a surge in generic availability and a sharp decline in revenue for branded versions.

4. Are there ongoing R&D efforts to develop new forms of metolazone?
   No significant new R&D efforts are known; focus is on novel therapies with improved safety and efficacy.

5. What regulatory challenges does metolazone face?
   Warnings related to electrolyte imbalance and dehydration can restrict use and impact market access.

References

[1] MarketsandMarkets, "Diuretics Market by Type, Application, and Region," 2022.

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