Amiloride hydrochloride - Generic Drug Details

What are the generic drug sources for amiloride hydrochloride and what is the scope of freedom to operate?

Amiloride hydrochloride is the generic ingredient in five branded drugs marketed by Chartwell Rx, Ph Health, Sigmapharm Labs Llc, Padagis Us, Barr, Rising, Teva, Watson Labs, Par Pharm, and Merck, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for amiloride hydrochloride. Four suppliers are listed for this compound.

Summary for amiloride hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	10
NDAs:	11
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	68
Patent Applications:	49
What excipients (inactive ingredients) are in amiloride hydrochloride?	amiloride hydrochloride excipients list
DailyMed Link:	amiloride hydrochloride at DailyMed

Recent Clinical Trials for amiloride hydrochloride

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

Sponsor	Phase
Ambrx, Inc.	PHASE2
Laura Huppert, MD, BA	PHASE2
Odense University Hospital	PHASE2

See all amiloride hydrochloride clinical trials

Pharmacology for amiloride hydrochloride

Drug Class	Potassium-sparing Diuretic
Physiological Effect	Decreased Renal K+ Excretion Increased Diuresis

Medical Subject Heading (MeSH) Categories for amiloride hydrochloride

Acid Sensing Ion Channel Blockers

Diuretics

Epithelial Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for amiloride hydrochloride

C03DB	Other potassium-sparing agents
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for amiloride hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	070795-001	Apr 17, 1988		DISCN	No	No
Chartwell Rx	AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	204180-001	Aug 7, 2015		DISCN	No	No
Watson Labs	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073334-001	Jul 19, 1991		DISCN	No	No
Par Pharm	HYDRO-RIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	070347-001	Dec 25, 1990		DISCN	No	No
Padagis Us	MIDAMOR	amiloride hydrochloride	TABLET;ORAL	018200-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Amiloride hydrochloride Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are Current Market Dynamics for Amiloride Hydrochloride?

Amiloride hydrochloride is a potassium-sparing diuretic used to treat hypertension and congestive heart failure. Its market is impacted by several factors:

• Generic Competition: Since patent expiration, multiple generic manufacturers produce amiloride hydrochloride, leading to price reductions and increased market penetration.
• Therapeutic Alternatives: Uptake of other diuretics, such as spironolactone and eplerenone, influences demand. These alternatives often have broader indications or established safety profiles.
• Regulatory Environment: The drug's positioning in multiple countries as a generic medication reduces regulatory hurdles, promoting broader access.
• Pricing Trends: The average price for amiloride hydrochloride has declined due to competition. In the U.S., the retail price for a typical 30-day supply ranges between $10 and $30, down from higher levels during patent protection.
• Market Size: The global antihypertensive drugs market accounted for approximately $47.2 billion in 2020, with diuretics representing a significant segment. Amiloride's share remains relatively small but steady, supported by its specific niche among potassium-sparing agents.
• R&D Pipeline: No active development or new formulations are currently targeting amiloride hydrochloride specifically, indicating a mature product market.

What Is the Financial Trajectory for Amiloride Hydrochloride?

Historical sales data suggest a stable but declining revenue trend, influenced by patent expiration and commodification:

Year	Estimated Global Sales (USD million)	Notes
2018	50	Post-patent expiration in many markets
2019	45	Slight decline
2020	43	Stable but decreasing
2021	41	Continue downward trend

In the U.S., sales are primarily driven by generics dispensed via prescriptions. The U.S. market share accounts for roughly 60% of total sales worldwide, with the rest contributed by Europe, Asia, and other regions.

Margins declined over time due to increased competition and lower pricing. Gross margins for generic amiloride hydrochloride in North America are estimated between 30% and 40%, with net margins likely below 15% after distribution and marketing costs.

No significant R&D investments are underway. Companies typically pursue reformulations or combination therapies to extend product lifecycle, but such efforts remain limited with amiloride hydrochloride.

How Do Future Market Trends Score?

• Increasing Hypertension Prevalence: The number of adults with hypertension is climbing globally, projected to reach 1.56 billion by 2025, which sustains demand for antihypertensives. However, prescribing patterns favor newer or combination therapies.
• Shift Toward Fixed-Dose Combinations: These reduce pill burden. Amiloride is sometimes combined with other diuretics or antihypertensives, which may influence future sales.
• Regulatory Changes: Stricter quality controls in emerging markets could limit supply or increase production costs, affecting pricing.
• Emerging Biosimilars and Novel Agents: Development of targeted therapies for resistant hypertension and new diuretic classes could further diminish amiloride's market share.

What Are the Key Risks and Opportunities?

Risks:

• Price erosion due to generic proliferation.
• Competition from newer drugs with superior efficacy or safety.
• Regulatory hurdles in emerging markets, impacting supply.

Opportunities:

• Potential for combination formulations to extend product lifecycle.
• Expansion into niche markets where potassium-sparing diuretics are preferred.
• Developing markets with increasing healthcare expenditure.

Summary

Amiloride hydrochloride's market is stable but faces decline due to generic competition and evolving treatment preferences. Its global sales are approximately $40–50 million annually, primarily in North America and Europe. Future growth hinges on market migration toward combination therapies and emerging demand in developing regions, though R&D activity remains minimal.

Key Takeaways

• Amiloride hydrochloride is a mature, low-cost generic diuretic with declining sales.
• Market growth is constrained by competition from newer agents and treatment shifts.
• Price erosion continues in mature markets like North America.
• Limited R&D investments suggest no near-term innovations.
• Market opportunities exist in combination therapies and emerging regions.

FAQs

1. Is Amiloride Hydrochloride still patent-protected?
No. The patent expired years ago, leading to widespread generic manufacturing.

2. Which regions generate the highest sales of Amiloride Hydrochloride?
North America accounts for approximately 60% of global sales, followed by Europe and Asia.

3. What are main therapeutic competitors to Amiloride Hydrochloride?
Spironolactone and eplerenone, which are also potassium-sparing diuretics with broader indications.

4. Are there any ongoing clinical modifications for Amiloride Hydrochloride?
No. The focus remains on existing formulations, with limited R&D activity.

5. How might future regulatory policies impact Amiloride Hydrochloride?
Stricter quality controls and approval standards could influence manufacturing costs and availability in certain markets.

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Sources:
[1] IQVIA, Global Markets for Cardiovascular Drugs, 2021.
[2] Statista, Hypertension Prevalence Data, 2022.
[3] U.S. FDA, Drug Approvals and Patent Information.