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Last Updated: April 2, 2025

HYDROFLUMETHIAZIDE AND RESERPINE Drug Patent Profile


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When do Hydroflumethiazide And Reserpine patents expire, and when can generic versions of Hydroflumethiazide And Reserpine launch?

Hydroflumethiazide And Reserpine is a drug marketed by Usl Pharma and Watson Labs and is included in three NDAs.

The generic ingredient in HYDROFLUMETHIAZIDE AND RESERPINE is hydroflumethiazide; reserpine. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide; reserpine profile page.

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Summary for HYDROFLUMETHIAZIDE AND RESERPINE
US Patents:0
Applicants:2
NDAs:3
DailyMed Link:HYDROFLUMETHIAZIDE AND RESERPINE at DailyMed
Drug patent expirations by year for HYDROFLUMETHIAZIDE AND RESERPINE

US Patents and Regulatory Information for HYDROFLUMETHIAZIDE AND RESERPINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Watson Labs HYDROFLUMETHIAZIDE AND RESERPINE hydroflumethiazide; reserpine TABLET;ORAL 088110-001 Mar 22, 1983 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs HYDROFLUMETHIAZIDE AND RESERPINE hydroflumethiazide; reserpine TABLET;ORAL 088127-001 Mar 22, 1983 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Usl Pharma HYDROFLUMETHIAZIDE AND RESERPINE hydroflumethiazide; reserpine TABLET;ORAL 088195-001 Oct 26, 1983 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
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Hydroflumethiazide and Reserpine

Introduction

Hydroflumethiazide and reserpine are components of a combination drug used to treat hypertension, a condition that affects millions worldwide. Understanding the market dynamics and financial trajectory of this drug combination is crucial for pharmaceutical companies, investors, and healthcare professionals.

Mechanism of Action

To grasp the market dynamics, it's essential to understand how these drugs work. Hydroflumethiazide is a thiazide diuretic that reduces blood pressure by increasing urine production, thereby decreasing the amount of fluid in the body. Reserpine, on the other hand, works by controlling nerve impulses, which helps to lower blood pressure by acting on the heart and blood vessels[1].

Market Need and Demand

Hypertension is a significant health issue globally, contributing to cardiovascular diseases, strokes, and kidney failures. The demand for effective antihypertensive medications is high and continues to grow due to the increasing prevalence of hypertension, particularly in aging populations and those with lifestyle-related health issues[3].

Competitive Landscape

The market for antihypertensive drugs is highly competitive, with various classes of medications available, including ACE inhibitors, calcium channel blockers, and diuretics. The success of a drug like the hydroflumethiazide-reserpine combination depends on its efficacy, safety profile, and convenience of use. For instance, the once-daily dosing of this combination has been highlighted as a significant advantage, improving patient compliance and reducing costs[2].

Promotional and Marketing Strategies

In the pharmaceutical industry, promotional activities play a crucial role in market dominance. However, research has shown that the first firm to introduce a new type of product often gains a substantial and enduring sales advantage, despite heavy promotional expenditures by competitors. This suggests that innovation and early market entry are key factors in the success of antihypertensive drugs[4].

Financial Trajectory

Development and Approval Costs

Developing a new drug, including combination therapies like hydroflumethiazide and reserpine, is a costly and time-consuming process. The average cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, which adds to the financial risk[3].

Revenue Potential

Despite the high development costs, successful antihypertensive drugs can generate significant revenue. The global pharmaceutical market, driven by the increasing burden of chronic diseases, is projected to exceed $1.4 trillion by 2028. Cardiovascular drugs, in particular, represent a substantial market segment, valued at $155.6 billion in 2021 and expected to grow further[3].

Cost-Effectiveness

The hydroflumethiazide-reserpine combination offers a cost-effective treatment option. Studies have shown that this combination provides convenient once-daily dosing, improved compliance, and decreased costs, which are attractive features for both patients and healthcare systems[2].

Side Effects and Safety Profile

The safety profile of the hydroflumethiazide-reserpine combination is another critical factor influencing its market dynamics. While generally well-tolerated, this combination can have side effects such as breathing problems, changes in diabetes medication needs, and increased uric acid levels. These factors can impact patient adherence and overall market acceptance[1].

Regulatory Environment

The regulatory environment significantly impacts the financial trajectory of pharmaceuticals. Stricter regulatory hurdles and shorter exclusivity periods can reduce the return on investment (ROI) for pharmaceutical R&D. For instance, the ROI for the 20 largest pharmaceutical companies has declined to just 1.2% in recent years, highlighting the challenges in sustaining current R&D models[3].

Patient Compliance and Outcomes

Patient compliance is a key determinant of the success of any antihypertensive medication. The hydroflumethiazide-reserpine combination has been shown to maintain significant reductions in blood pressure over long periods without signs of tachyphylaxis, which enhances patient compliance and overall treatment outcomes[2].

Economic Impact

The economic impact of effective antihypertensive treatments extends beyond the pharmaceutical industry. By reducing the risk of cardiovascular events, strokes, and kidney failures, these medications can significantly lower healthcare costs in the long term. For example, a Cochrane review highlighted that first-line ACE inhibitors can reduce total cardiovascular events, stroke, and coronary heart disease, leading to substantial cost savings[5].

Key Takeaways

  • Market Demand: High demand due to the prevalence of hypertension.
  • Competitive Advantage: Once-daily dosing and cost-effectiveness.
  • Financial Risks: High development costs and regulatory challenges.
  • Revenue Potential: Significant revenue generation in the growing pharmaceutical market.
  • Safety Profile: Generally well-tolerated but with potential side effects.
  • Regulatory Environment: Impact of stricter regulations on ROI.
  • Patient Compliance: Improved compliance due to convenient dosing.

FAQs

What is the primary use of the hydroflumethiazide-reserpine combination?

The primary use of the hydroflumethiazide-reserpine combination is to treat high blood pressure (hypertension).

How does the hydroflumethiazide-reserpine combination work?

Hydroflumethiazide works as a diuretic to reduce fluid in the body, while reserpine controls nerve impulses to lower blood pressure.

What are the significant advantages of the hydroflumethiazide-reserpine combination?

The combination offers convenient once-daily dosing, improved patient compliance, and decreased costs.

What are the potential side effects of the hydroflumethiazide-reserpine combination?

Potential side effects include breathing problems, changes in diabetes medication needs, and increased uric acid levels.

How does the regulatory environment impact the financial trajectory of this drug combination?

Stricter regulatory hurdles and shorter exclusivity periods can reduce the ROI for pharmaceutical R&D, making it challenging to sustain current R&D models.

Sources

  1. Mayo Clinic: Reserpine, hydralazine, and hydrochlorothiazide (oral route)[1].
  2. PubMed: Review of therapy with a hydroflumethiazide-reserpine combination[2].
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research and Development[3].
  4. FTC: Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets[4].
  5. Cochrane Library: First-line drugs for hypertension[5].

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