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Last Updated: April 21, 2025

HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE Drug Patent Profile


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Which patents cover Hydrochlorothiazide W/ Reserpine And Hydralazine, and when can generic versions of Hydrochlorothiazide W/ Reserpine And Hydralazine launch?

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

The generic ingredient in HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE 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.

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US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Watson Labs HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE hydralazine hydrochloride; hydrochlorothiazide; reserpine TABLET;ORAL 083770-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
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Market Dynamics and Financial Trajectory for the Drug: Hydrochlorothiazide with Reserpine and Hydralazine

Introduction

The combination of hydrochlorothiazide, reserpine, and hydralazine is a potent antihypertensive medication used to treat high blood pressure (hypertension). Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

Prevalence of Hypertension

Hypertension is a widespread health issue, affecting millions of people globally. According to various studies, the prevalence of hypertension is expected to increase due to factors such as aging populations, lifestyle changes, and the rising incidence of obesity and diabetes[3].

Demand for Antihypertensive Medications

The demand for antihypertensive medications, including combinations like hydrochlorothiazide, reserpine, and hydralazine, is driven by the growing need to manage and treat hypertension effectively. This demand is further bolstered by the increasing awareness of the risks associated with uncontrolled high blood pressure, such as heart attacks, strokes, and kidney failure[1][4].

Mechanism of Action and Therapeutic Benefits

How the Combination Works

  • Reserpine: Acts by controlling nerve impulses, reducing the heart rate and blood vessel constriction, thereby lowering blood pressure.
  • Hydralazine: A vasodilator that relaxes blood vessels, increasing blood supply to the heart and reducing its workload.
  • Hydrochlorothiazide: A thiazide diuretic that reduces the amount of water in the body by increasing urine flow, which helps lower blood pressure[1][4].

Therapeutic Outcomes

The combination of these drugs provides a synergistic effect, offering comprehensive blood pressure management. This combination is particularly beneficial for patients who require multiple mechanisms to control their hypertension effectively.

Market Segmentation

Patient Demographics

The market for this drug is segmented across various patient demographics, including:

  • Geriatric Population: Older adults are more likely to suffer from hypertension and may require more complex treatment regimens, making this combination a viable option[1][4].
  • Patients with Comorbidities: Individuals with conditions like diabetes, heart disease, and kidney disease may benefit from the multifaceted approach this combination offers.

Geographic Markets

The demand for antihypertensive medications varies geographically, with higher demand in regions with aging populations and higher prevalence of hypertension. Developed countries like the United States and Europe, as well as emerging markets in Asia and Latin America, are key segments.

Competitive Landscape

Existing Competitors

The antihypertensive market is highly competitive, with numerous single-agent and combination therapies available. However, the unique mechanism of action and the synergistic benefits of the hydrochlorothiazide, reserpine, and hydralazine combination differentiate it from other treatments.

Generic and Branded Options

Both generic and branded versions of this combination are available, influencing market dynamics. Generic options often provide a cost-effective alternative, while branded versions may offer additional benefits such as improved formulation or patient support programs.

Financial Trajectory

Revenue Projections

The revenue generated by this combination is expected to grow steadily due to the increasing prevalence of hypertension and the need for effective treatment options. Here are some key financial indicators:

  • Market Size: The global antihypertensive market is projected to grow significantly over the next decade, driven by the increasing demand for effective treatments.
  • Sales Growth: The sales of hydrochlorothiazide, reserpine, and hydralazine combinations are anticipated to increase as more patients are diagnosed with hypertension and require comprehensive treatment.

Pricing Strategies

Pricing strategies play a crucial role in the financial trajectory of this drug. Factors such as competition, regulatory environments, and patient affordability influence pricing decisions. Generic versions typically offer lower prices, while branded versions may command a premium due to their perceived value and additional services.

Cost-Benefit Analysis

From a healthcare economics perspective, the cost-benefit analysis of this combination is favorable. By effectively managing hypertension, this drug helps reduce the risk of costly complications such as heart attacks, strokes, and kidney failure, thereby reducing overall healthcare expenditures.

Regulatory Environment

Approval and Compliance

The regulatory environment is critical for the market dynamics of any pharmaceutical product. The combination of hydrochlorothiazide, reserpine, and hydralazine is approved by regulatory bodies such as the FDA and is subject to ongoing monitoring for safety and efficacy.

Patent Expirations

Patent expirations can significantly impact the market dynamics, as generic versions become available. However, the combination of these three drugs, being older medications, is largely off-patent, allowing for widespread generic availability.

Challenges and Opportunities

Side Effects and Safety Concerns

While this combination is effective, it comes with potential side effects such as drowsiness, dizziness, and increased risk of gout or potassium loss, particularly in elderly patients. Managing these side effects and ensuring patient safety is a continuous challenge[1][4].

Emerging Trends and Innovations

Emerging trends in personalized medicine and precision healthcare offer opportunities for tailoring antihypertensive treatments to individual patient needs. Additionally, advancements in drug delivery systems and formulations could enhance patient compliance and treatment outcomes.

Key Takeaways

  • Growing Demand: The demand for antihypertensive medications, including the combination of hydrochlorothiazide, reserpine, and hydralazine, is driven by the increasing prevalence of hypertension.
  • Therapeutic Benefits: The synergistic effect of this combination provides comprehensive blood pressure management.
  • Competitive Landscape: The market is competitive, but the unique mechanism of action of this combination differentiates it from other treatments.
  • Financial Trajectory: Revenue is expected to grow due to increasing demand and the need for effective treatments.
  • Regulatory Environment: Regulatory compliance and ongoing monitoring are crucial for market stability.

FAQs

Q: What are the primary components of the hydrochlorothiazide, reserpine, and hydralazine combination?

A: The primary components are hydrochlorothiazide (a thiazide diuretic), reserpine (a nerve impulse controller), and hydralazine (a vasodilator).

Q: How does this combination lower blood pressure?

A: Hydrochlorothiazide reduces water in the body by increasing urine flow, reserpine controls nerve impulses to reduce heart rate and blood vessel constriction, and hydralazine relaxes blood vessels to increase blood supply to the heart.

Q: What are the potential side effects of this combination?

A: Potential side effects include drowsiness, dizziness, increased risk of gout, and potassium loss, particularly in elderly patients.

Q: Is this combination safe for use in elderly patients?

A: While generally safe, elderly patients may be more sensitive to the effects of this medication, experiencing drowsiness, dizziness, or faintness more frequently.

Q: Can this medication be used during breastfeeding?

A: Studies suggest minimal risk to the infant from hydralazine, but there is limited information on reserpine and hydrochlorothiazide. It is advisable to weigh the potential benefits against the risks before using this medication while breastfeeding[1][4].

Sources

  1. Mayo Clinic: Reserpine, hydralazine, and hydrochlorothiazide (oral route)[1].
  2. Davis's Drug Guide: Hydralazine[2].
  3. American Heart Association: Overview of the Evolution of Hypertension[3].
  4. Drugs.com: Reserpine, hydralazine, and hydrochlorothiazide (Oral)[4].
  5. Mayo Clinic: Hydralazine and hydrochlorothiazide (oral route)[5].

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