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Last Updated: December 22, 2024

AMILORIDE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for amiloride hydrochloride and what is the scope of patent protection?

Amiloride hydrochloride is the generic ingredient in five branded drugs marketed by Chartwell Rx, Endo Operations, 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: 86
Clinical Trials: 65
Patent Applications: 1,892
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

SponsorPhase
Yale UniversityPhase 1
University of UtahEarly Phase 1
Center for Addiction and Mental HealthEarly Phase 1

See all AMILORIDE HYDROCHLORIDE clinical trials

Pharmacology for AMILORIDE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for AMILORIDE HYDROCHLORIDE

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
Padagis Us MIDAMOR amiloride hydrochloride TABLET;ORAL 018200-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 071111-001 May 10, 1988 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 204180-001 Aug 7, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 073209-001 Oct 31, 1991 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 073334-001 Jul 19, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sigmapharm Labs Llc AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET;ORAL 079133-001 Jan 30, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 073357-001 Nov 27, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AMILORIDE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amiloride Hydrochloride

Introduction

Amiloride hydrochloride, a potassium-sparing diuretic, has been gaining significant traction in the pharmaceutical market due to its efficacy in treating conditions such as hypertension, congestive heart failure, and fluid retention disorders. Here, we delve into the market dynamics and financial trajectory of amiloride hydrochloride, highlighting key drivers, restraints, opportunities, and challenges.

Mechanism of Action and Clinical Applications

Amiloride hydrochloride works by selectively blocking sodium transport in the distal tubule of the nephron, thereby inhibiting sodium-potassium exchange. This mechanism is independent of aldosterone, making it a valuable treatment option for patients with edematous states and hypertension[2].

Market Size and Growth

The global amiloride hydrochloride market has been experiencing robust growth. As of 2023, the market size was estimated at USD 10.93 billion, and it is projected to reach USD 11.72 billion in 2024. By 2030, the market is expected to grow to USD 17.45 billion at a Compound Annual Growth Rate (CAGR) of 6.90%[4].

Market Segmentation

The amiloride hydrochloride market is segmented based on several factors:

  • Type: Available in 2.5mg and 5mg formulations.
  • Application: Primarily used in hospitals, clinics, and other healthcare settings.
  • Geography: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are key regions[1][4].

Market Drivers

Several factors are driving the growth of the amiloride hydrochloride market:

  • Increasing Prevalence of Hypertension and Heart Diseases: The rising incidence of cardiovascular diseases globally is a significant driver, particularly in aging populations[4].
  • Technological Advancements: Improvements in drug formulations and delivery systems are enhancing the efficacy and safety of amiloride hydrochloride.
  • Government Initiatives: Policies and programs aimed at managing hypertension and cardiovascular health are boosting the demand for this drug.
  • Shift Towards Personalized Medicine: The trend towards precision healthcare is increasing the adoption of targeted therapies like amiloride hydrochloride[4].

Market Restraints

Despite the growth, there are several restraints affecting the market:

  • Slow Adoption in Emerging Markets: Low healthcare expenditure in developing countries hampers the widespread adoption of amiloride hydrochloride.
  • Stringent Regulatory Policies: The approval process for new formulations containing amiloride hydrochloride is often lengthy and stringent, posing challenges for market expansion[4].

Market Opportunities

The market presents several opportunities for growth:

  • Growing Geriatric Population: The increasing number of older adults susceptible to hypertension and other cardiovascular diseases amplifies the demand for amiloride hydrochloride.
  • Expansion of Generic Drug Production: The production of generic versions of amiloride hydrochloride can increase market penetration, especially in regions with lower healthcare budgets.
  • Government Initiatives and Healthcare Budgets: Increased focus on cardiovascular health and accessibility of medications in government healthcare programs can drive market growth[4].

Market Challenges

Several challenges need to be addressed:

  • Supply Chain Integrity: Maintaining a stable supply chain and dealing with raw material shortages are critical challenges.
  • Competitive Landscape: The risk of generic alternatives gaining market share and intensifying competition among manufacturers is a significant challenge[4].

Regional Market Analysis

The market for amiloride hydrochloride varies significantly across different regions:

  • North America: High demand is supported by strong healthcare systems and significant investments in personalized medicine and telehealth platforms in the United States and Canada.
  • Europe: Countries like Germany, France, and the UK exhibit a substantial market presence due to high healthcare standards and extensive pharmaceutical research.
  • Asia-Pacific: The region is seeing growth driven by increasing healthcare investments and awareness, particularly in countries like China and Japan.
  • Middle East and Africa: Saudi Arabia and South Africa are leading in pharmaceutical uptake amid growing healthcare investments and awareness[4].

Regulatory Framework

The regulatory landscape plays a crucial role in shaping the market:

  • United States: Governed by the FDA, the focus is on innovation, fast-track approvals, and rigorous post-marketing surveillance.
  • Europe: Regulated by the EMA, the market involves navigating complex country-specific regulations.
  • Japan: Under the PMDA, early regulatory engagement and close local partnerships are necessary due to high compliance costs and lengthy approval timelines[4].

Financial Projections

The financial trajectory of the amiloride hydrochloride market is promising:

  • Revenue Growth: From USD 10.93 billion in 2023 to USD 17.45 billion by 2030, the market is expected to grow at a CAGR of 6.90%[4].
  • Investment Opportunities: The growing demand and expanding market offer significant investment opportunities, particularly in research and development and generic drug production.

Key Players

Several key players are driving the market forward:

  • Perrigo
  • Chartwell Pharmaceuticals
  • Par Pharmaceutical
  • Sigmapharm Laboratories
  • Hangzhou Minsheng Pharmaceutical
  • Jiangsu Desano[1].

Consumer Behavior and Economic Impact

The use of amiloride hydrochloride has a positive economic impact by reducing the risk of severe complications and lowering healthcare costs. For instance, in Bangladesh, hypertension medication has shown a high return on investment, highlighting the economic benefits of managing cardiovascular diseases effectively[5].

Conclusion

The amiloride hydrochloride market is poised for significant growth driven by increasing prevalence of hypertension and heart diseases, technological advancements, and supportive healthcare policies. While there are challenges such as slow adoption in emerging markets and stringent regulatory policies, the opportunities for expansion, particularly in generic drug production and government initiatives, are substantial.

Key Takeaways

  • The global amiloride hydrochloride market is projected to grow from USD 10.93 billion in 2023 to USD 17.45 billion by 2030 at a CAGR of 6.90%.
  • The market is driven by the increasing prevalence of hypertension and heart diseases, technological advancements, and government initiatives.
  • Key regions include North America, Europe, Asia-Pacific, and the Middle East and Africa.
  • Challenges include slow adoption in emerging markets and stringent regulatory policies.
  • Opportunities exist in generic drug production and government healthcare initiatives.

FAQs

Q: What is the primary mechanism of action of amiloride hydrochloride? A: Amiloride hydrochloride selectively blocks sodium transport in the distal tubule of the nephron, thereby inhibiting sodium-potassium exchange[2].

Q: What are the key drivers of the amiloride hydrochloride market? A: The key drivers include the increasing prevalence of hypertension and heart diseases, technological advancements, government initiatives, and the shift towards personalized medicine[4].

Q: Which regions are leading in the adoption of amiloride hydrochloride? A: North America, Europe, and the Asia-Pacific region are leading in the adoption of amiloride hydrochloride due to strong healthcare systems and significant investments in healthcare[4].

Q: What are the major challenges facing the amiloride hydrochloride market? A: The major challenges include slow adoption in emerging markets, stringent regulatory policies, and the risk of generic alternatives gaining market share[4].

Q: How does the regulatory framework impact the amiloride hydrochloride market? A: The regulatory framework, governed by agencies such as the FDA, EMA, and PMDA, influences the market through approval processes, compliance costs, and local partnerships[4].

Sources

  1. Market Research Intellect: Amiloride Hydrochloride Market Size, Scope And Forecast Report.
  2. PubMed: Mechanism of action, pharmacokinetics, adverse effects of amiloride hydrochloride.
  3. PW Consulting: Market Dynamics and Emerging Trends in Amiloride Hydrochloride Tablets.
  4. 360 Research Reports: Amiloride hydrochloride Market Size & Share 2025-2030.
  5. World Bank: Hypertension and Type-2 Diabetes in Bangladesh: Continuum of Care Assessment and Opportunities for Action.

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