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
France	1563612
Germany	1695487
Switzerland	478796	Verfahren zur Herstellung von 1-acylierten 3-Indol-aliphatischen Säuren

Market Dynamics and Financial Trajectory for MODURETIC 5-50

Last updated: August 1, 2025

Introduction

MODURETIC 5-50 is a combination pharmaceutical product containing amiloride hydrochloride and hydrochlorothiazide, used predominantly for managing hypertension and edema. Understanding its market dynamics and financial trajectory involves analyzing key factors such as demand drivers, competitive landscape, regulatory environment, and emerging trends. This analysis offers strategic insights for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Market Overview and Therapeutic Significance

MODURETIC 5-50 combines a potassium-sparing diuretic (amiloride) with a thiazide diuretic (hydrochlorothiazide), providing enhanced antihypertensive efficacy while mitigating potassium depletion risks associated with monotherapy. Its established role in hypertension and edema management sustains steady demand within the cardiovascular therapy segment, particularly in markets with high hypertension prevalence.

The global antihypertensive drugs market was valued at approximately USD 24 billion in 2021 and is projected to grow at a CAGR of 4-6% through 2028, driven by increasing hypertension prevalence, aging populations, and advancements in drug formulations (source: Grand View Research). MODURETIC's specific niche benefits from the longstanding clinical acceptance of combination diuretics and incremental demand in both developed and emerging markets.

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Market Drivers

1. Rising Global Hypertension Prevalence

Hypertension affects over 1.2 billion individuals worldwide, a number projected to rise with aging populations and lifestyle factors. Increases in hypertension cases directly correlate with higher demand for effective antihypertensive options like MODURETIC 5-50.

2. Aging Population and Chronic Disease Burden

Elderly populations are more susceptible to hypertension and related cardiovascular conditions. Governments and healthcare providers prioritize cost-effective, efficacious treatments, boosting the market sales of combination diuretics.

3. Therapy Optimization and Patient Compliance

Clinicians favor fixed-dose combinations like MODURETIC to improve patient adherence, simplify regimens, and reduce polypharmacy-related risks. This trend bolsters consistent demand within treatment protocols.

4. Expanding Access in Emerging Markets

Emerging economies exhibit rising healthcare infrastructure and increasing adoption of generic medications, including diuretics, supporting broader distribution and market penetration.

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Competitive Landscape

1. Market Players and Patent Status

While original formulations of MODURETIC are marketed by established pharmaceutical companies, many regions see a proliferation of generic equivalents that intensify market competition. Patent expirations tend to lead to price erosion but also expand access due to affordability.

2. Innovation and Next-Generation Therapies

Emerging roles for newer antihypertensive classes, such as ACE inhibitors, ARBs, and direct vasodilators, influence the market share of traditional diuretics. However, combination diuretics retain essential status, especially where cost considerations are paramount.

3. Regulatory and Pricing Strategies

Market access is heavily impacted by regulatory approvals, mandatory generics pathways, and price controls prevalent in regions like Europe and parts of Asia. Companies leveraging strategic pricing, licensing, or co-marketing can influence MODURETIC's market share.

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Regulatory and Patent Landscape

1. Patent Expiry and Generics Market Entry

MODURETIC's original patents have expired or are nearing expiration in numerous jurisdictions, paving the way for generic manufacturers. This trend is expected to intensify competition but also encourage price reductions, expanding access.

2. Regulatory Approvals and Label Expansion

Efforts to seek approval for new indications, or combination with other antihypertensives, could bolster market longevity. Regulatory flexibility in key markets influences the drug's commercial trajectory.

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Financial Trajectory and Revenue Outlook

1. Revenue Projections

The mature segment's growth is primarily driven by volume expansion due to increased disease burden and generic competition. Price stabilization or erosion remains region-dependent but generally trending downward in highly competitive markets.

Forecast:

• Short-Term (1-3 years): Flat or slight decline in branded sales due to generic competition.
• Medium-Term (3-5 years): Stabilization as the drug becomes a core component in combination regimens.
• Long-Term (5+ years): Revenue decline expected unless new formulations or indications emerge.

2. Impact of Generics and Market Penetration

In key markets like India, China, and parts of Latin America, generic versions are expected to capture significant market share, aiding supply chain resilience but exerting pricing pressure. Multi-billion-dollar global sales could diminish slightly but sustain due to volume.

3. Strategic Opportunities

Innovation in formulations, such as sustained-release versions or fixed-dose combinations including other drug classes, could prolong market relevance and sustain revenue streams.

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Emerging Trends and Future Outlook

1. Patient-Centric Therapies

Adoption of once-daily fixed-dose combinations enhances compliance, creating niche opportunities for MODURETIC variants with improved delivery systems.

2. Digital and Remote Monitoring Integration

Incorporation of telemedicine and remote patient monitoring could influence treatment adherence and demand for cost-effective diuretics.

3. Regulatory Shifts and Market Dynamics

Policy initiatives targeting affordable hypertension management and drug price controls may accelerate generic uptake, further reducing margins but expanding patient access.

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Conclusion

The financial and market outlook for MODURETIC 5-50 is characterized by steady demand rooted in its established therapeutic role and favorable safety profile. However, the landscape is increasingly shaped by patent expirations, generics proliferation, and evolving therapeutic standards favoring newer agents. Companies that innovate through formulation improvements or expand indications may effectively extend the product's lifecycle, maintain revenue streams, and capitalize on ongoing global health challenges related to hypertension.

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Key Takeaways

• Growing Global Burden: Rising hypertension prevalence sustains core demand for MODURETIC 5-50, especially across aging populations and emerging markets.
• Competitive Pressures: Patent expirations and generic competition will likely drive prices downward but also broaden access.
• Market Expansion Opportunities: Innovation in drug delivery, fixed-dose combinations, and new indications can fortify long-term revenue prospects.
• Regulatory Environment: Favorable regulatory pathways and market access strategies influence profitability and market sustainability.
• Strategic Focus: Stakeholders should prioritize cost-effective formulations, geographic expansion, and compliance with evolving policies to optimize financial trajectory.

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FAQs

1. How will patent expirations affect MODURETIC 5-50's market share?
Patent expirations typically lead to increased generic competition, exerting downward pressure on prices and potentially reducing branded sales. However, increased accessibility may offset revenue decline through higher volume sales.

2. What role do emerging markets play in the future of MODURETIC 5-50?
Emerging markets present significant growth opportunities due to rising hypertension prevalence and cost-sensitive healthcare systems favoring generics. Market penetration and localized manufacturing can augment sales volumes.

3. Are there prospects for MODURETIC 5-50 to be combined with newer antihypertensive agents?
Yes, developing fixed-dose combinations with newer classes like ARBs or ACE inhibitors can enhance therapeutic efficacy and adherence, extending the product's relevance.

4. What regulatory hurdles could impact MODURETIC’s future?
Regulatory challenges include approval processes for biosimilars or generics, changes in pricing policies, and safety or efficacy requirements for expanded indications.

5. How is digital health integration influencing the demand for diuretics like MODURETIC?
Digital health tools optimize hypertension management strategies, potentially increasing adherence and demand for cost-effective medications. However, technological adoption varies by region and healthcare system.

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Sources:
[1] Grand View Research. Antihypertensive Drugs Market Size & Trends Report. 2022.