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Last Updated: December 22, 2024

Hydralazine hydrochloride; hydrochlorothiazide - Generic Drug Details


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

Hydralazine hydrochloride; hydrochlorothiazide is the generic ingredient in twenty-one branded drugs marketed by Novartis, Strides Pharma, Solvay, Superpharm, Watson Labs, Ivax Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Industries, and Lederle, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for hydralazine hydrochloride; hydrochlorothiazide
Recent Clinical Trials for hydralazine hydrochloride; hydrochlorothiazide

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SponsorPhase
Vanderbilt University Medical CenterPhase 4
National Center for Research Resources (NCRR)Phase 4
Vanderbilt UniversityPhase 1

See all hydralazine hydrochloride; hydrochlorothiazide clinical trials

US Patents and Regulatory Information for hydralazine hydrochloride; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Pharms HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088358-001 Apr 10, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 085440-001 Mar 4, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma HYDRA-ZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088957-001 Oct 21, 1985 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CAM-AP-ES hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 084897-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 085446-001 Mar 4, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 083770-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESOLINE-ESIDRIX hydralazine hydrochloride; hydrochlorothiazide TABLET;ORAL 012026-002 Approved Prior to Jan 1, 1982 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

Hydralazine hydrochloride; hydrochlorothiazide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydralazine and Hydrochlorothiazide

Introduction

Hydralazine and hydrochlorothiazide are two medications often combined to treat hypertension, a condition that affects a significant portion of the global population. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

Increasing Prevalence of Hypertension

The global market for hydralazine and hydrochlorothiazide is driven primarily by the rising prevalence of hypertension. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from high blood pressure, and this number is expected to increase to 29% by 2025, particularly in economically developing nations[1][3].

Geriatric Population Growth

The increasing geriatric population is another key factor driving the market growth. Older adults are more susceptible to hypertension and heart diseases due to the loss of muscle mass and elasticity in blood vessels, making them a significant target demographic for these medications[1][3].

Healthcare Expenditure and R&D Activities

Increased healthcare expenditure and robust research and development activities by pharmaceutical companies also propel the market. The launch of novel drugs and generic versions, such as the generic hydrochlorothiazide/triamterene combination launched by Schein in 2020, further fuels market growth[1].

Market Trends

New Product Launches

The market is witnessing a surge in new product launches. For instance, Beximco Pharmaceuticals Ltd. launched Telma Plus in 2018, which combines hydrochlorothiazide with telmisartan, an angiotensin II antagonist. Such launches enhance treatment options and convenience for patients, thereby boosting market growth[1].

Generic Versions

The availability of generic versions of these drugs is another trend. Generic hydralazine and hydrochlorothiazide are more affordable and widely accessible, which is particularly beneficial in regions with high healthcare costs and limited access to branded medications[3].

Financial Trajectory

Market Size and Growth Rate

The global hydralazine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period. Similarly, the hydrochlorothiazide market is anticipated to grow significantly due to the increasing demand for antihypertensive medications[1][3].

Revenue Segmentation

The market revenue is segmented by type, application, end user, and region. For hydralazine, the tablet segment is expected to grow significantly, while for hydrochlorothiazide, the market is segmented into various applications including hypertension, coronary artery disease, and heart failure[1][3].

Distribution Channels

Hospital pharmacies are expected to dominate the distribution channel segment due to the high demand for these medications in clinical settings. Retail pharmacies and online pharmacies also play a significant role, especially with the increasing trend of online healthcare services[3].

Competitive Landscape

Key Players

The market for hydralazine and hydrochlorothiazide is highly competitive, with several key players such as Novartis, Teva, Aurobindo Pharma, Mylan, and others. These companies are engaged in strategic business expansions, collaborative ventures, and intense research and development activities to maintain their market position[1][3].

Promotional Expenditures

Promotional activities are a critical aspect of the market. Sellers of oral diuretics, including hydrochlorothiazide, spend a higher percentage of their sales on promotion compared to other prescription drug markets. This high promotional expenditure is a result of the competitive nature of the market and the need to differentiate products[5].

Challenges and Restraints

Side Effects

Despite the growing demand, both hydralazine and hydrochlorothiazide are associated with significant side effects. For hydralazine, these include low blood pressure, headache, rash, and dizziness, while hydrochlorothiazide can cause gout, hypokalemia, and other electrolyte imbalances. These side effects can hamper market growth and necessitate careful patient monitoring[2][3][4].

Regulatory and Economic Factors

The high cost of alternative medications and the availability of generic versions can also impact market dynamics. Additionally, regulatory changes and economic factors such as healthcare policy reforms can influence the financial trajectory of these drugs[3].

Regional Outlook

Global Market

The global market for these medications is diverse, with significant growth expected in regions such as North America, Europe, and Asia Pacific. The increasing prevalence of hypertension and heart diseases in these regions drives the demand for antihypertensive medications[1][3].

Regional Variations

Regional variations in healthcare infrastructure, regulatory environments, and patient demographics also influence the market. For example, hospital pharmacies in developed regions like the U.S. and Europe are expected to grow at a significant rate, while in developing regions, retail pharmacies may play a more dominant role[3].

Key Takeaways

  • The market for hydralazine and hydrochlorothiazide is driven by the increasing prevalence of hypertension and the growing geriatric population.
  • New product launches and the availability of generic versions are key trends.
  • The market is highly competitive with significant promotional expenditures.
  • Side effects and regulatory factors are major restraints.
  • Regional variations in healthcare infrastructure and patient demographics influence market dynamics.

FAQs

What are the primary drivers of the hydralazine and hydrochlorothiazide market?

The primary drivers include the increasing prevalence of hypertension and the growing geriatric population, along with increased healthcare expenditure and robust R&D activities.

Which companies are key players in the hydralazine and hydrochlorothiazide market?

Key players include Novartis, Teva, Aurobindo Pharma, Mylan, and others.

What are the common side effects associated with hydralazine and hydrochlorothiazide?

Hydralazine can cause low blood pressure, headache, rash, and dizziness, while hydrochlorothiazide can cause gout, hypokalemia, and other electrolyte imbalances.

How does the availability of generic versions impact the market?

The availability of generic versions makes these medications more affordable and accessible, particularly in regions with high healthcare costs.

What is the expected growth rate for the hydralazine market?

The global hydralazine market is expected to grow at a CAGR of 3.5% during the forecast period.

Sources

  1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
  2. Drugs.com: Hydralazine and hydrochlorothiazide Advanced Patient Information
  3. Biospace: Global Hydralazine Market to Grow at a CAGR of 3.5% During ...
  4. Mayo Clinic: Hydralazine and hydrochlorothiazide (oral route) - Mayo Clinic
  5. Federal Trade Commission: Sales, Promotion, and Product Differentiation in Two Prescription ...

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