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Last Updated: December 22, 2024

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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When do Hydralazine Hydrochloride And Hydrochlorothiazide patents expire, and what generic alternatives are available?

Hydralazine Hydrochloride And Hydrochlorothiazide is a drug marketed by Solvay, Superpharm, and Watson Labs. and is included in eight NDAs.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.

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Summary for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Drug patent expirations by year for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

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

See all HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE clinical trials

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087608-001 Feb 8, 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
Superpharm HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 089200-001 Feb 9, 1987 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
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087213-001 Feb 8, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 087609-001 Feb 8, 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 AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydralazine Hydrochloride and Hydrochlorothiazide

Introduction to Hydralazine Hydrochloride and Hydrochlorothiazide

Hydralazine hydrochloride and hydrochlorothiazide are two medications commonly used in the treatment of hypertension and related cardiovascular diseases. Hydralazine hydrochloride is a vasodilator, while hydrochlorothiazide is a thiazide diuretic. When combined, these medications provide a comprehensive approach to managing high blood pressure.

Growing Prevalence of Hypertension and Heart Diseases

The primary driver of the market for these medications is the increasing prevalence of hypertension and heart diseases globally. According to the World Health Organization (WHO), approximately 1 billion people worldwide suffer from high blood pressure, making it a leading cause of death globally[1][4].

Demographic Factors

The geriatric population is another significant factor contributing to market growth. Elderly individuals are more susceptible to hypertension and heart diseases due to the loss of muscle mass and elasticity in blood vessels. This demographic shift is expected to continue driving demand for both hydralazine hydrochloride and hydrochlorothiazide[1][4].

Mechanism of Action

Hydralazine Hydrochloride

Hydralazine hydrochloride works by relaxing blood vessels, thereby increasing the supply of blood and oxygen to the heart while reducing its workload. This vasodilatory effect helps in lowering blood pressure and alleviating symptoms associated with hypertension and heart failure[5].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that inhibits sodium resorption in the distal convoluted tubules of the kidney, leading to increased urine production and a reduction in blood volume. This diuretic effect contributes to a decrease in blood pressure by reducing the volume of fluid in the blood vessels and by causing vasodilation over time[2].

Market Segmentation

By Type

The market for hydralazine hydrochloride is segmented into tablets and injectable forms. The tablet form is widely used for treating hypertension and heart failure, while the injectable form is used for managing severe hypertension. Hydrochlorothiazide is also available in tablet form and is often used in combination with hydralazine hydrochloride[1][4].

By Distribution Channel

The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to grow at a significant rate due to the high volume of prescriptions filled in these settings[1][4].

By Indication

The market is segmented by indication into hypertension, congestive heart failure, and other cardiovascular diseases. The hypertension segment is expected to grow significantly due to the rising prevalence of high blood pressure globally[1][4].

Competitive Landscape

The market for hydralazine hydrochloride and hydrochlorothiazide is highly competitive, with several key players involved in research and development, strategic expansions, and collaborative ventures. Major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen[1][4].

Financial Trajectory

Market Size and Growth Rate

The global hydralazine hydrochloride market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period. This growth is attributed to the increasing demand for antihypertensive medications and the expanding geriatric population[1][4].

Regional Outlook

The market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America, particularly the U.S., is a significant market due to the high prevalence of hypertension, affecting approximately 75 million adults[1][4].

Revenue Forecast

The global market for hydralazine hydrochloride was valued at a significant amount in 2023 and is anticipated to reach a higher value by 2030. The revenue growth is driven by the increasing adoption of these medications in various therapeutic applications and the expanding distribution channels[1][4].

Challenges and Restraints

Side Effects and Safety Concerns

Despite their widespread use, both hydralazine hydrochloride and hydrochlorothiazide have several side effects. Hydralazine hydrochloride can cause low blood pressure, headache, rash, and dizziness, with rare but serious side effects including heart problems and lupus-like syndrome. Hydrochlorothiazide is associated with hyperglycemia, gout flares, and dyslipidemia[1][2][4].

High Cost of Alternative Medications

The high cost of alternative antihypertensive medications can restrain market growth. However, the cost-effectiveness of hydralazine hydrochloride, especially in its generic form, continues to drive its adoption[1][4].

Regulatory and Quality Control Aspects

Methods for the assay of hydralazine hydrochloride have been validated for accuracy, reproducibility, and cost-effectiveness, adhering to international standards such as those set by the International Conference on Harmonization (ICH) Q2 (R1)[1].

Market Strategies and Promotions

The pharmaceutical industry, including the market for hydralazine hydrochloride and hydrochlorothiazide, is known for significant promotional expenditures. Companies spend a substantial portion of their sales on promotion to differentiate their products and maintain market share[1].

Impact of COVID-19

The COVID-19 pandemic has presented both challenges and opportunities for the pharmaceutical industry. While the pandemic has disrupted supply chains, it has also accelerated research and development activities, particularly for medications that can manage comorbid conditions associated with COVID-19. This has indirectly impacted the market for hydralazine hydrochloride and hydrochlorothiazide by highlighting the importance of antihypertensive medications in managing overall health[3].

Key Takeaways

  • The global market for hydralazine hydrochloride and hydrochlorothiazide is driven by the rising prevalence of hypertension and heart diseases.
  • The geriatric population is a significant demographic factor contributing to market growth.
  • The market is segmented by type, route of administration, indication, and distribution channel.
  • Key players are engaged in intense competition through research and development and strategic ventures.
  • The market is expected to grow at a CAGR of 3.5% during the forecast period.
  • Side effects and safety concerns are critical factors that need to be managed.
  • Regulatory and quality control measures are essential for ensuring the quality of these medications.

FAQs

What is the primary driver of the hydralazine hydrochloride market?

The primary driver of the hydralazine hydrochloride market is the increasing prevalence of hypertension and heart diseases globally[1][4].

Which segment is expected to grow significantly in the hydralazine hydrochloride market?

The tablet segment is expected to grow significantly due to its ease of administration and lower cost compared to injectable forms[1][4].

What are the common side effects of hydralazine hydrochloride and hydrochlorothiazide?

Common side effects of hydralazine hydrochloride include low blood pressure, headache, rash, and dizziness. Hydrochlorothiazide is associated with hyperglycemia, gout flares, and dyslipidemia[1][2][4].

Who are the major players in the hydralazine hydrochloride market?

Major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen[1][4].

What is the expected CAGR of the global hydralazine hydrochloride market during the forecast period?

The global hydralazine hydrochloride market is expected to grow at a CAGR of 3.5% during the forecast period[1][4].

Sources:

  1. DrugPatentWatch - Hydralazine hydrochloride - Generic Drug Details[1]
  2. NCBI Bookshelf - Hydrochlorothiazide - StatPearls[2]
  3. Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)[3]
  4. Emergen Research - Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period[4]
  5. Drugs.com - Hydralazine and hydrochlorothiazide Advanced Patient Information[5]

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