You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

HYDRALAZINE, HYDROCHLOROTHIAZIDE W Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Hydralazine, Hydrochlorothiazide W, and what generic alternatives are available?

Hydralazine, Hydrochlorothiazide W is a drug marketed by Watson Labs and is included in one NDA.

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

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for HYDRALAZINE, HYDROCHLOROTHIAZIDE W?
  • What are the global sales for HYDRALAZINE, HYDROCHLOROTHIAZIDE W?
  • What is Average Wholesale Price for HYDRALAZINE, HYDROCHLOROTHIAZIDE W?
Summary for HYDRALAZINE, HYDROCHLOROTHIAZIDE W
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:HYDRALAZINE, HYDROCHLOROTHIAZIDE W at DailyMed
Drug patent expirations by year for HYDRALAZINE, HYDROCHLOROTHIAZIDE W

US Patents and Regulatory Information for HYDRALAZINE, HYDROCHLOROTHIAZIDE W

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 085771-001 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, HYDROCHLOROTHIAZIDE W Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydralazine and Hydrochlorothiazide

Market Overview

The market for hydralazine and its combination with hydrochlorothiazide is driven by several key factors, primarily the increasing prevalence of hypertension and heart diseases globally. Here’s a detailed look at the market dynamics and financial trajectory of these medications.

Growing Prevalence of Hypertension and Heart Diseases

The primary driver of the market is the rising prevalence of hypertension, which affects approximately 1 billion people worldwide, making it a leading cause of death globally according to the World Health Organization (WHO)[1][4].

Demographic Factors

The geriatric population plays a significant role in driving 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 hydralazine and its combinations[1][4].

Market Segmentation

By Type

The market is segmented into tablets and injections for hydralazine. The tablet segment, which includes combinations like hydralazine and hydrochlorothiazide, is expected to grow significantly due to its ease of administration and lower cost compared to injectable forms. These tablets are available in various strengths and are widely used for treating hypertension and heart failure[1][4].

By Route of Administration

The market is also segmented by route of administration into oral and injectable forms. The oral segment, which includes the combination of hydralazine and hydrochlorothiazide, is anticipated to dominate the market due to its convenience and cost-effectiveness. The injectable segment is used for managing severe hypertension and is further sub-segmented into intravenous (IV) and intramuscular (IM) forms[1][4].

By Indication

Hydralazine, often combined with hydrochlorothiazide, is used to treat hypertension, congestive heart failure, and other conditions. The hypertension segment is expected to grow significantly due to the rising prevalence of high blood pressure globally[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].

Competitive Landscape

The market for hydralazine and its combinations 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 market, including its combinations, 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 hydralazine market 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 hydralazine in various therapeutic applications and the expanding distribution channels[1][4].

Market Strategies and Promotions

Promotional Expenditures

The pharmaceutical industry, including the hydralazine market, is known for significant promotional expenditures. Companies spend a substantial portion of their sales on promotion to differentiate their products and maintain market share. This is particularly evident in markets with few sellers of differentiated products[1].

Therapeutic Use and Mechanism

Hydralazine

Hydralazine is a direct vasodilator that works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload. It is used orally to treat essential hypertension and intravenously to rapidly reduce blood pressure in hypertensive emergencies[2].

Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic that helps reduce the amount of water in the body by acting on the kidneys to increase the flow of urine. When combined with hydralazine, it enhances the blood pressure-lowering effects and helps manage hypertension more effectively[5].

Side Effects and Safety Concerns

Hydralazine and its combinations can have several side effects, including low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects such as heart problems and lupus-like syndrome (hydralazine-induced lupus syndrome or HILS) can occur. The incidence of HILS is dose-dependent and typically manifests with arthralgias, myalgias, serositis, and fevers[2].

Regulatory and Quality Control Measures

Ensuring the quality of hydralazine products is crucial, and regulatory bodies play a significant role in this. Adherence to WHO's model list of essential medicines and other regulatory guidelines is essential for maintaining the quality and safety of these medications[3].

Enhancing Healthcare Team Outcomes

Hydralazine should not be considered a first-line agent for essential hypertension but can be considered in hypertension refractory to other first-line medications. The combination with hydrochlorothiazide can improve patient compliance and efficacy. However, newer hypertensive medications are often more efficacious with fewer adverse effects[2].

Regional Variations

The availability and pricing of hydralazine and its combinations vary significantly across different regions. For instance, in sub-Saharan Africa, the prices of antihypertensive medicines, including hydralazine, can be higher than recommended, affecting accessibility[3].

Key Takeaways

  • Rising Prevalence of Hypertension: The increasing prevalence of hypertension and heart diseases globally is the primary driver of the market.
  • Geriatric Population: The elderly are more susceptible to hypertension and heart diseases, driving demand.
  • Market Segmentation: The market is segmented by type, route of administration, indication, and distribution channel.
  • Competitive Landscape: The market is highly competitive with key players involved in R&D and strategic ventures.
  • Financial Trajectory: The global hydralazine market is expected to grow at a CAGR of 3.5% during the forecast period.
  • Side Effects and Safety: Serious side effects such as HILS and drug-induced liver injury (DILI) need to be managed.
  • Regulatory Measures: Adherence to regulatory guidelines is essential for ensuring product quality.

FAQs

What is the primary driver of the hydralazine market?

The primary driver of the hydralazine market is the increasing prevalence of hypertension and heart diseases globally.

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

The tablet segment, including combinations like hydralazine and hydrochlorothiazide, is expected to grow significantly due to its ease of administration and lower cost.

What are the common side effects of hydralazine?

Common side effects include low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects such as heart problems and lupus-like syndrome can occur.

Who are the major players in the hydralazine market?

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

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

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

Sources

  1. DrugPatentWatch: "Hydralazine hydrochloride - Generic Drug Details"
  2. NCBI Bookshelf: "Hydralazine - StatPearls"
  3. ResearchGate: "Prices of antihypertensive medicines in sub-Saharan Africa and alignment to WHO's model list of essential medicines"
  4. Biospace: "Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period - Emergen Research"
  5. Mayo Clinic: "Hydralazine and hydrochlorothiazide (oral route)"

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.