AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Amiloride hydrochloride; hydrochlorothiazide is the generic ingredient in three branded drugs marketed by Barr, Chartwell Rx, Rising, Teva, Watson Labs, Par Pharm, and Merck, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	2
Clinical Trials:	12
DailyMed Link:	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Instituto de Cardiologia do Rio Grande do Sul	Phase 3
Hospital de Clinicas de Porto Alegre	Phase 3
Guangdong Provincial People's Hospital	Phase 4

See all AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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; HYDROCHLOROTHIAZIDE

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
Watson Labs	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	073334-001	Jul 19, 1991		DISCN	No	No
Barr	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111-001	May 10, 1988	AB	RX	No	No

Expired US Patents for AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amiloride Hydrochloride and Hydrochlorothiazide

Introduction

Amiloride hydrochloride and hydrochlorothiazide are crucial medications in the management of hypertension, heart failure, and edema. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, investors, and healthcare providers.

Market Drivers

Growing Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases, such as hypertension and heart failure, is a significant driver for the demand of amiloride hydrochloride and hydrochlorothiazide. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[1][3].

Aging Global Population

The global population is aging, which contributes to an increased incidence of age-related health issues, including cardiovascular diseases. This demographic shift amplifies the demand for medications like amiloride hydrochloride and hydrochlorothiazide[1][3].

Increased Healthcare Expenditure

Growing investments in healthcare infrastructure and rising healthcare expenditure support the increased demand for these medications. Governments and private entities are investing more in healthcare, which includes the development and distribution of essential drugs like amiloride hydrochloride and hydrochlorothiazide[3].

Market Restraints

Side Effects and Safety Concerns

Both amiloride hydrochloride and hydrochlorothiazide have potential side effects that can hamper market growth. For instance, hydrochlorothiazide can cause excessive potassium loss, and the combination of amiloride and hydrochlorothiazide can lead to hyperkalemia in some patients. These safety concerns necessitate careful monitoring and can limit the use of these drugs in certain patient populations[2][5].

Stringent Approval Processes

The pharmaceutical industry is heavily regulated, and the approval process for new drugs or formulations is stringent. This can delay the introduction of new products to the market and impact the financial trajectory of companies involved in the development of amiloride hydrochloride and hydrochlorothiazide[3].

Emergence of Alternative Therapies

The development of alternative therapies and medications can also pose a challenge to the market growth of amiloride hydrochloride and hydrochlorothiazide. As new treatments emerge, patients and healthcare providers may opt for these alternatives, reducing the demand for traditional medications[3].

Market Opportunities

Research and Development

Investing in research and development can unlock new formulations or combination therapies that improve efficacy or patient compliance. For example, molecular modifications to reduce side effects while enhancing therapeutic outcomes could set a precedent for future applications of amiloride hydrochloride and hydrochlorothiazide[3].

Expanding Distribution Networks

Enhancing distribution networks and forming local partnerships can help tap into emerging markets, particularly in developing regions where access to cardiovascular medications is increasingly prioritized. This strategy can help companies sustain growth and capitalize on new opportunities[3].

Strategic Collaborations

Companies that focus on strategic collaborations and adaptive business models in response to market shifts are likely to sustain growth. Partnerships for the manufacturing of generic versions of amiloride hydrochloride and hydrochlorothiazide can also be a lucrative opportunity[3].

Financial Trajectory

Amiloride Hydrochloride Market Size

The global amiloride hydrochloride market size was estimated at USD 10.93 billion in 2023 and is expected to reach USD 11.72 billion in 2024. It is projected to grow to USD 17.45 billion by 2030, at a Compound Annual Growth Rate (CAGR) of 6.90%[3].

Hydrochlorothiazide Market Growth

The hydrochlorothiazide market is also expected to grow significantly, driven by the increasing prevalence of hypertension and heart diseases. The market growth is further supported by the rise in FDA approvals and the growing awareness for the treatment of heart diseases[1].

Revenue Streams

The revenue streams for these medications come from various end-users, including healthcare facilities, ambulatory services, and home care settings. The market is highly competitive, with key players such as Beijing Second Pharmaceutical, Torrent Pharmaceuticals, and Novartis, among others[1][3].

Competitive Landscape

Key Market Players

The market for amiloride hydrochloride and hydrochlorothiazide is highly competitive, with several key players. Companies like Teva, Aurobindo Pharma, and Mylan are significant contributors to the market. These companies are involved in continuous research and development to improve existing formulations and expand their market share[1][3].

Market Share Analysis

The market share analysis reveals that the competition is intense, with companies competing based on the efficacy of their products, pricing strategies, and distribution networks. Porter’s five forces analysis illustrates the potency of buyers and suppliers in the market, highlighting the competitive intensity and how the competition will take shape in the coming years[1].

Regional Market Analysis

Global Market

The global market for amiloride hydrochloride and hydrochlorothiazide is diverse, with different regions presenting unique opportunities and challenges. Developing regions are particularly important due to the growing prevalence of cardiovascular diseases and the increasing investment in healthcare infrastructure[1][3].

Regional Growth

The market growth varies by region, with economically developing nations showing a higher growth rate due to the increasing incidence of hypertension and other cardiovascular diseases. Strategic partnerships and local collaborations are crucial for tapping into these emerging markets[3].

Key Takeaways

• The market for amiloride hydrochloride and hydrochlorothiazide is driven by the growing prevalence of cardiovascular diseases and an aging global population.
• Side effects and stringent approval processes are significant restraints to market growth.
• Research and development, along with strategic collaborations and expanding distribution networks, offer opportunities for growth.
• The financial trajectory indicates a steady growth rate, with the amiloride hydrochloride market expected to reach USD 17.45 billion by 2030.
• The competitive landscape is intense, with key players focusing on improving formulations and expanding market share.

FAQs

What are the primary drivers of the amiloride hydrochloride and hydrochlorothiazide market?

The primary drivers include the growing prevalence of cardiovascular diseases, an aging global population, and increased healthcare expenditure.

What are the potential side effects of amiloride hydrochloride and hydrochlorothiazide?

Potential side effects include excessive potassium loss, hyperkalemia, and damage to organs such as the kidneys and parathyroid gland with prolonged or repeated exposure.

How is the competitive landscape of the amiloride hydrochloride and hydrochlorothiazide market?

The market is highly competitive, with several key players competing based on product efficacy, pricing strategies, and distribution networks.

What is the projected market size of amiloride hydrochloride by 2030?

The global amiloride hydrochloride market is projected to reach USD 17.45 billion by 2030, at a CAGR of 6.90%.

What strategies can companies adopt to sustain growth in this market?

Companies can focus on strategic collaborations, expanding distribution networks, and investing in research and development to improve formulations and patient compliance.

Cited Sources

1. Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
2. DailyMed - Amiloride Hydrochloride and Hydrochlorothiazide Tablets
3. 360iResearch - Amiloride Hydrochloride Market Size & Share 2025-2030
4. PubMed - Multiclinic comparison of amiloride, hydrochlorothiazide ...
5. MSD - Amiloride / Hydrochlorothiazide Formulation - Safety Data Sheet