MODURETIC 5-50 Drug Patent Profile

Which patents cover Moduretic 5-50, and what generic alternatives are available?

Moduretic 5-50 is a drug marketed by Merck and is included in one NDA.

The generic ingredient in MODURETIC 5-50 is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Moduretic 5-50

A generic version of MODURETIC 5-50 was approved as amiloride hydrochloride; hydrochlorothiazide by BARR on May 10^th, 1988.

Summary for MODURETIC 5-50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	109
DailyMed Link:	MODURETIC 5-50 at DailyMed

Recent Clinical Trials for MODURETIC 5-50

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Centre Hospitalier Universitaire de Saint Etienne	Phase 4

See all MODURETIC 5-50 clinical trials

US Patents and Regulatory Information for MODURETIC 5-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for MODURETIC 5-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MODURETIC 5-50	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	018201-001	Approved Prior to Jan 1, 1982

International Patents for MODURETIC 5-50

See the table below for patents covering MODURETIC 5-50 around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	1470088
Sweden	302133	Förfarande för framställning av derivat av alpha-(3-indolyl)-ättiksyror med inflammationshämmande verkan
Switzerland	466285	Verfahren zur Herstellung von 1-Acyl-3-indolyl-essigsäure oder deren Ester
France	1559559
Germany	1770132

Market Dynamics and Financial Trajectory for MODURETIC 5-50

Last updated: March 15, 2026

What is MODURETIC 5-50?

MODURETIC 5-50 is a combination medication containing amiloride hydrochloride (5 mg) and furosemide (50 mg). It is primarily prescribed to manage edema associated with congestive heart failure, liver cirrhosis, and renal disorders. Its primary function is to promote diuresis while minimizing potassium loss through its amiloride component.

Market Overview

The global diuretics market, which includes medications like MODURETIC, was valued at approximately USD 5.7 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 3.4% from 2023 to 2030 (Research and Markets, 2023). The demand drives from increased prevalence of hypertension, heart failure, and renal diseases worldwide.

Key Market Drivers

1. Growing Burden of Cardiovascular Diseases: An estimated 522 million people worldwide suffer from hypertension, contributing to increased demand for diuretics (WHO, 2022).

2. Aging Population: Globally, populations aged 60 and above comprise a significant share. The age group has increased susceptibility to edema, hypertension, and heart failure, boosting demand for diuretics like MODURETIC.

3. Introduction of Fixed-Dose Combinations (FDCs): Combining diuretics with other antihypertensives in single formulations improves compliance and expands market penetration.

4. Medical Guidelines Favoring Diuretics: National and international hypertension and heart failure management guidelines list diuretics as first-line therapy, supporting market stability.

Competitive Landscape

Major competitors within the fixed-dose combination segment include:

• Boehringer Ingelheim: Manufactures various diuretic combinations.
• Teva Pharmaceuticals: Produces generic versions.
• Mylan (now part of Viatris): Offers competing formulations.
• Sun Pharma: Focuses on regional markets with generic diuretic FDCs.

MODURETIC 5-50's market share remains limited in certain regions due to regulatory constraints and patent statuses. However, in markets like India and parts of Southeast Asia, generics of such formulations account for a significant segment.

Regulatory Factors

Approval statuses influence market access:

• United States: No specific FDA approval for MODURETIC 5-50; only generic equivalents are available.
• European Union: Similar regulatory approach, with concerns around safety and efficacy of fixed-dose combinations.
• Emerging Markets: Regulatory pathways are often less restrictive, allowing rapid entry of generics.

Financial Trajectory

Projected revenue for MODURETIC 5-50 is expected to follow the broader diuretic market growth trends, scaled by regional market penetration:

Region	2023 Market Size (USD millions)	2030 Projected Market Size (USD millions)	CAGR	Comments
North America	1,200	1,600	3.2%	High adoption of combination therapy
Europe	950	1,250	3.4%	Regulatory hurdles are fewer for generics
Asia-Pacific	2,000	2,900	4.2%	Market expansion driven by large patient pool
Rest of World	550	800	4.1%	Growing awareness and healthcare infrastructure

In the emerging markets, competition from local manufacturers could suppress prices and impact margins.

Pricing Trends

Generic availability drives price compression. In mature markets, the average retail price per unit for MODURETIC 5-50 ranges from USD 0.50 to USD 1.20. Price reductions of 5-10% annually are common due to increased competition and policy pressures.

Risks and Challenges

• Regulatory Delays: Variations in approval processes can restrict market entry.
• Patent Expirations: Loss of exclusivity may lead to increased generic competition.
• Safety Concerns: Fixed-dose combinations face scrutiny over safety profiles, which could impact approval or reimbursement.
• Market Saturation: Maturation of existing markets limits growth potential.

Strategic Opportunities

• Expanding into emerging markets with high disease burdens.
• Developing modified-release formulations to improve adherence.
• Engaging with healthcare providers through awareness campaigns highlighting the benefits of combination therapy.

Key Takeaways

• The global diuretics market expands steadily, driven by aging populations and increasing cardiovascular disease prevalence.
• MODURETIC 5-50’s sales depend heavily on regional regulatory environments and market penetration strategies.
• Generic competition and pricing pressures are significant factors influencing financial outcomes.
• The growth outlook remains positive for regions with expanding healthcare access, particularly Asia-Pacific.
• Patent expiries and safety profile considerations will influence long-term competitive positioning.

FAQs

1. What are the main medical indications for MODURETIC 5-50? It is used primarily for edema in heart failure, liver cirrhosis, and renal disorders.

2. How does the combination of amiloride and furosemide benefit patients? It balances diuretic potency with potassium-sparing effects, enhancing safety and efficacy.

3. What is the current market size for MODURETIC 5-50 globally? Specific data is limited; however, diuretic combinations form a multibillion-dollar segment, with regional variation.

4. What regulatory challenges exist for fixed-dose combinations like MODURETIC 5-50? Regulatory agencies assess safety, efficacy, and labeling, often requiring robust clinical data, which may delay approval.

5. What growth opportunities exist for MODURETIC 5-50? Market expansion into developing regions, introduction of innovative formulations, and increased adoption of combination therapy support growth.

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References

[1] Research and Markets. (2023). Global Diuretics Market Forecast, 2023–2030.
[2] World Health Organization. (2022). Hypertension Fact Sheet.
[3] MarketWatch. (2023). Diuretics Market Trends and Analysis.