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Last Updated: December 22, 2024

Fosinopril sodium; hydrochlorothiazide - Generic Drug Details


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

Fosinopril sodium; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for fosinopril sodium; hydrochlorothiazide
Recent Clinical Trials for fosinopril sodium; hydrochlorothiazide

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SponsorPhase
Ranbaxy Laboratories LimitedN/A

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Pharmacology for fosinopril sodium; hydrochlorothiazide

US Patents and Regulatory Information for fosinopril sodium; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076739-001 Dec 17, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076961-002 Sep 28, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 077144-002 Aug 16, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076961-001 Sep 28, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076945-002 Jul 5, 2006 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079245-001 Jul 9, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 076608-001 Dec 3, 2004 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

Expired US Patents for fosinopril sodium; hydrochlorothiazide

Fosinopril sodium; hydrochlorothiazide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fosinopril Sodium and Hydrochlorothiazide

Introduction

Fosinopril sodium and hydrochlorothiazide are crucial medications in the treatment of hypertension and heart failure. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The global fosinopril sodium market is anticipated to experience robust growth in the coming years. This growth is driven by increasing consumer demand, technological advancements, and changing market trends[1].

Consumer Demand

Consumer demand for fosinopril sodium has risen due to its efficacy in treating hypertension and heart failure. The drug's ability to prevent the heart and arteries from functioning incorrectly by reducing the workload on them has made it a preferred choice among patients and healthcare providers[1].

Technological Advancements

The market is driven by the demand for technologically advanced and highly sophisticated products. Pharmaceutical companies are investing in research and development to enhance the formulation, delivery, and efficacy of fosinopril sodium, which is expected to further boost market growth[1].

Competitive Landscape

The competitive landscape of the fosinopril sodium market is diverse and includes major players such as Huahai Pharma, Sino Pharma, Viatris, ANI Pharma, Apotex, Aurobindo Pharma, Bristol Myers Squibb, and others. These companies are focusing on primary strategies, market share, SWOT profiles, and financial analysis to strengthen their market position[1].

Key Players

  • Huahai Pharma: Known for its extensive product portfolio and strong research capabilities.
  • Sino Pharma: Focused on expanding its global presence through strategic partnerships.
  • Viatris: Emphasizing on innovative product development and market expansion.
  • ANI Pharma: Concentrating on enhancing product safety and security[1].

Market Segmentation

The fosinopril sodium market is segmented based on product type and application.

Product Type

  • Tablets: The most common form of fosinopril sodium, widely used due to its ease of administration.
  • Capsules: Another form that offers an alternative for patients who prefer or require it[1].

Application

  • Hypertension: Fosinopril sodium is primarily used to treat high blood pressure, reducing the risk of heart disease and stroke.
  • Chronic Heart Failure: The drug is also indicated for the treatment of heart failure with reduced ejection fraction (HFrEF), improving symptoms and reducing hospitalizations[2].

Financial Trajectory

The financial trajectory of the fosinopril sodium market is promising, with several factors contributing to its growth.

Revenue and Production

The market size is calculated based on historical data, and each segment has been studied to provide production and revenue data for both historical and forecast periods. The report indicates a significant increase in revenue due to the growing demand for the drug[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the fosinopril sodium market. While business operations were severely impacted, the pandemic also highlighted the importance of healthcare and pharmaceuticals, leading to increased demand for essential medications like fosinopril sodium[1].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of fosinopril sodium and hydrochlorothiazide is crucial for their effective use.

Mechanism of Action

Fosinopril sodium works by inhibiting the angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to angiotensin II, a powerful vasoconstrictor. This action reduces blood pressure and alleviates symptoms of heart failure[2][4].

Absorption and Elimination

  • Fosinopril Sodium: The absolute absorption of fosinopril averages 36% of an oral dose, primarily absorbed in the proximal small intestine. The drug is eliminated approximately equally by the liver and kidney[4][5].
  • Hydrochlorothiazide: Peak plasma concentrations are achieved in 1 to 2.5 hours, with an absorption rate of 50 to 80%. Hydrochlorothiazide is eliminated by the kidney, with a terminal half-life of 5 to 15 hours[4][5].

Clinical Studies and Efficacy

Clinical studies have demonstrated the efficacy of fosinopril sodium and hydrochlorothiazide in treating hypertension and heart failure.

Fosinopril Efficacy/Safety Trial (FEST)

The FEST trial showed that fosinopril improved exercise tolerance and attenuated clinical deterioration in patients with heart failure[2].

Combination Therapy

Studies have shown that the combination of fosinopril and hydrochlorothiazide results in increased antihypertensive effects compared to monotherapy. Peak blood pressure reductions were achieved 2 to 6 hours after dosing, with sustained effects over 24 hours[4][5].

Off-Label Uses

Fosinopril sodium has several off-label uses, including:

Acute Myocardial Infarction

Early treatment with fosinopril has been shown to benefit patients with acute myocardial infarction and prevent left ventricular remodeling[2].

Diabetic Nephropathy

Fosinopril combined with losartan has been effective in reducing urine protein excretion, serum creatinine, and BUN in patients with diabetic nephropathy[2].

HIV-Associated Nephropathy

Fosinopril is also efficacious in treating HIV-associated nephropathy (HIVAN)[2].

Market Trends and Consumer Behavior

Market trends and consumer behavior play a significant role in shaping the fosinopril sodium market.

Safety and Security

Consumers are increasingly focusing on product safety and security, which is expected to drive the market positively over the forecast period[1].

Import and Export Policies

The global fosinopril sodium market can be affected by import and export policies, which may impact the availability and pricing of the drug in different regions[1].

Regional Markets

The fosinopril sodium market is segmented regionally, with varying growth rates and market dynamics.

Emerging Markets

Emerging markets are expected to contribute significantly to the growth of the fosinopril sodium market due to increasing healthcare expenditure and growing awareness of cardiovascular diseases[1].

Challenges and Restrictions

Despite the positive outlook, the fosinopril sodium market faces several challenges and restrictions.

Regulatory Hurdles

Pharmaceutical companies must navigate stringent regulatory requirements, which can delay market entry and impact revenue[1].

Competition

The market is highly competitive, with numerous players vying for market share. This competition can lead to pricing pressures and reduced profit margins[1].

Recommendations for Market Players

To strengthen their market position, companies are advised to:

Invest in R&D

Continuously invest in research and development to enhance product formulations and delivery mechanisms[1].

Expand Global Presence

Focus on expanding their global presence through strategic partnerships and market expansion strategies[1].

Enhance Product Safety and Security

Prioritize product safety and security to align with changing consumer attitudes and preferences[1].

Key Takeaways

  • The global fosinopril sodium market is expected to grow strongly due to increasing consumer demand and technological advancements.
  • The drug is primarily used for treating hypertension and heart failure, with several off-label uses.
  • The competitive landscape includes major players focusing on R&D, market expansion, and product safety.
  • Clinical studies have demonstrated the efficacy of fosinopril sodium and hydrochlorothiazide in combination therapy.
  • Market trends and consumer behavior, particularly the focus on safety and security, will drive the market positively.

FAQs

What is the primary mechanism of action of fosinopril sodium?

Fosinopril sodium works by inhibiting the angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I to angiotensin II, a powerful vasoconstrictor[2].

What are the common forms of fosinopril sodium available in the market?

Fosinopril sodium is available in tablet and capsule forms[1].

How does the combination of fosinopril and hydrochlorothiazide affect blood pressure?

The combination of fosinopril and hydrochlorothiazide results in increased antihypertensive effects, with peak blood pressure reductions achieved 2 to 6 hours after dosing and sustained effects over 24 hours[4][5].

What are some off-label uses of fosinopril sodium?

Fosinopril sodium is used off-label for conditions such as acute myocardial infarction, diabetic nephropathy, and HIV-associated nephropathy[2].

How has the COVID-19 pandemic impacted the fosinopril sodium market?

The COVID-19 pandemic has had a mixed impact, with business operations severely affected but also highlighting the importance of healthcare and pharmaceuticals, leading to increased demand for essential medications like fosinopril sodium[1].

Sources

  1. Global Fosinopril Sodium Market Economical Growth, Growth Statistics, Economic crysis, Trends 2022-2030. EINPresswire.
  2. Fosinopril - StatPearls - NCBI Bookshelf. NCBI.
  3. Hydrochlorothiazide: Topics by Science.gov. Science.gov.
  4. Fosinopril Sodium and Hydrochlorothiazide Tablets, USPRx only. DailyMed.
  5. Fosinopril and Hydrochlorothiazide: Package Insert / Prescribing Info. Drugs.com.

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