MODURETIC 5-50 Drug Patent Profile

When do Moduretic 5-50 patents expire, and when can generic versions of Moduretic 5-50 launch?

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

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

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
Sweden	307133
Germany	1695491
Switzerland	464203	Verfahren zur Herstellung von 1-Acyl-3-indolyl-aliphatischen Säuren oder deren t-Butyl-Estern
Norway	122747
France	95657
Germany	1695489

Summary

Last updated: February 3, 2026

MODURETIC 5-50 combines amiloride and hydrochlorothiazide, addressing hypertension and edema. Its market prospects depend on patent status, generic competition, clinical efficacy, safety profile, prescribing trends, and regulatory environment. Investment potential hinges on patent expiration timing, pipeline development, and market share stability.

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What Are the Drug’s Indications and Therapeutic Profile?

MODURETIC 5-50 treats hypertension and edema. Its dual mechanism involves diuretic effects: hydrochlorothiazide reduces blood volume by inhibiting sodium reabsorption in the distal tubule, while amiloride blocks epithelial sodium channels, preventing potassium loss. Clinical evidence supports its efficacy in patients requiring combination therapy for resistant hypertension or edema associated with heart failure or renal disease.

Market Size and Demand Drivers

The global antihypertensive drugs market reached approximately USD 46.3 billion in 2021, projected to grow at a CAGR of 3.8% through 2028 [1]. Diuretics account for roughly 20-25% of this market. Factors supporting demand include aging populations, rising hypertension prevalence, and increased awareness. Diuretics are often first-line therapy, especially in primary care settings.

Competitive Landscape and Patent Status

MODURETIC 5-50 faces competition from several generic formulations and combination drugs:

• Patent Status: Original formulations or proprietary combinations may have patents expiring between 2023-2025, after which generics flood the market.
• Generics: Many countries permit generic substitution post-patent expiry, reducing prices and margins.
• Market Share: Dominated by leading pharmaceutical companies with established distribution channels.

Regulatory and Market Access Considerations

The drug is off-patent in numerous territories, with regulatory approval spanning US, EU, and emerging markets. Market access depends on:

• Pricing and reimbursement policies.
• Clinical guidelines adherence.
• Competitor patent litigations.

Research and Development Landscape

Current pipeline includes fixed-dose combinations (FDCs) with newer antihypertensive agents or mineralocorticoid receptor antagonists. Innovation areas focus on:

• Improved safety profiles reducing potassium or metabolic disturbances.
• Extended-release formulations for better compliance.

Financial and Investment Analysis

Key financial metrics for assessing investment:

• Pricing Trends: Modest premiums over generics in developed markets.
• Volume Trends: Steady prescription increases in primary care.
• Margin Impact: Post-patent expiry, margins decline due to generic competition.

Potential investors should evaluate:

• Patent expiration dates (anticipated 2023-2025).
• The size and growth rate of target markets.
• Pipeline differentiation and R&D pipeline progress.

Risks to Investment

• Accelerated patent expiry timings.
• Entry of generic competitors with aggressive pricing.
• Regulatory delays or reclassification affecting market access.
• Shifts in clinical guidelines favoring alternative therapies.

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Key Takeaways

1. Patents expiring circa 2023-2025 likely lead to increased generic competition, pressuring prices and margins.
2. Market demand remains steady due to the persistent prevalence of hypertension and edema.
3. Generic competition dominates in many territories, with brand premiums shrinking over time.
4. Pipeline developments aim at improving safety and compliance but face stiff regulatory hurdles.
5. Investment viability depends on timing relative to patent cliff and pipeline progress.

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FAQs

What is the timeline for patent expiration of MODURETIC 5-50?
Patent protections generally expire between 2023 and 2025 in key markets, opening the market to generics.

Are there major competitors to MODURETIC 5-50?
Yes. Multiple generic brands and FDCs with similar active ingredients compete across markets.

How does market access vary geographically?
US and EU markets have established reimbursement pathways. Emerging markets often face price constraints and regulatory differences.

What R&D efforts are underway to improve MODURETIC?
Focus areas include development of FDCs with newer antihypertensive agents, extended-release formulations, and formulations with improved safety profiles.

What are the key risks for investing in this drug?
Patent expiration timing, aggressive generic pricing, regulatory hurdles, and shifts in treatment guidelines.

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Citations

[1] Global antihypertensive market size and forecast, Fortune Business Insights, 2022.