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Last Updated: December 22, 2024

Hydrochlorothiazide; spironolactone - Generic Drug Details


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

Hydrochlorothiazide; spironolactone is the generic ingredient in three branded drugs marketed by Pfizer, Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, Ivax Pharms, Lederle, Parke Davis, Upsher Smith, Usl Pharma, and Vangard, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for hydrochlorothiazide; spironolactone
Recent Clinical Trials for hydrochlorothiazide; spironolactone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chiang Mai UniversityPhase 3
Medical University of BialystokN/A
Shanghai Jiao Tong University School of MedicinePhase 4

See all hydrochlorothiazide; spironolactone clinical trials

Pharmacology for hydrochlorothiazide; spironolactone
Drug ClassAldosterone Antagonist
Thiazide Diuretic
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for hydrochlorothiazide; spironolactone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087553-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Purepac Pharm SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 088054-001 Aug 18, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086881-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087948-001 Feb 22, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 085974-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mutual Pharm SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087267-001 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

Hydrochlorothiazide; spironolactone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Spironolactone and Hydrochlorothiazide

Market Overview

The combination of spironolactone and hydrochlorothiazide is a potent antihypertensive and diuretic medication, widely used in the treatment of hypertension, edema, and certain hormonal imbalances. This market has experienced significant growth in recent years, driven by several key factors.

Growing Prevalence of Hypertension and Cardiovascular Disorders

The increasing incidence of hypertension and related heart conditions globally has been a major driver for the spironolactone and hydrochlorothiazide market. As the global population ages and the prevalence of cardiovascular diseases rises, the demand for effective antihypertensive medications like spironolactone and hydrochlorothiazide has surged[3].

Therapeutic Benefits and Clinical Efficacy

Spironolactone, an aldosterone receptor antagonist, has been shown to effectively lower blood pressure in patients with hypertension, even when other medications have failed. Studies, such as the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm, have demonstrated that spironolactone significantly reduces systolic and diastolic blood pressure, making it a valuable addition to antihypertensive regimens[4].

Mechanism of Action

The combination of spironolactone and hydrochlorothiazide works synergistically to enhance diuretic and antihypertensive effects. Spironolactone acts by competitively binding to aldosterone receptors in the distal convoluted renal tubule, reducing sodium reabsorption and potassium excretion. Hydrochlorothiazide, on the other hand, inhibits sodium and water reabsorption in the cortical diluting segment of the distal renal tubule. This dual action helps in minimizing potassium loss and enhancing the overall antihypertensive effect[1].

Market Drivers

Increasing Awareness of Therapeutic Benefits

As awareness regarding the positive outcomes of spironolactone and hydrochlorothiazide in treating hypertension and edema increases, physicians are more likely to prescribe these medications, driving market growth. The drug's effectiveness in managing high blood pressure and its additional benefits, such as reducing arterial stiffness and improving cardiovascular outcomes, have contributed to its rising prescription rates[3].

Expanding Aging Population

The growing aging population is another significant driver. Older adults are more prone to hypertension and heart conditions, creating a substantial demand for spironolactone and hydrochlorothiazide[3].

Off-Label Use

Spironolactone's off-label use in managing conditions like hormonal acne and polycystic ovary syndrome (PCOS) has opened up new avenues for market growth. This expanded use has increased the drug's visibility and acceptance among a broader range of healthcare providers[3].

Market Opportunities

Expanding Untapped Markets

There is a significant opportunity for market players to expand their presence in regions where the prevalence of hypertension and heart disorders is increasing but access to effective medications is limited. Targeting these untapped markets can drive further growth[3].

Innovative Drug Formulations

The development of innovative drug formulations, such as extended-release tablets, could enhance patient compliance and open up new market opportunities. Research and development efforts to improve drug formulations and delivery systems have contributed to the market's expansion[3].

Focus on Pediatric Use

Exploring the effectiveness and safety of spironolactone and hydrochlorothiazide in the pediatric population could create new growth avenues for the market. This area is relatively underexplored and presents a potential for future market expansion[3].

Collaborations and Partnerships

Strategic collaborations with healthcare providers and pharmaceutical companies can enhance market penetration and promote the drug’s usage. Such partnerships can lead to better distribution channels, increased awareness, and improved patient outcomes[3].

Market Dynamics

Changing Patient Demographics

The market is influenced by changing patient demographics, such as the aging population and the increasing prevalence of hypertension. These changes necessitate continuous adaptation and innovation in drug development and marketing strategies[3].

Evolving Healthcare Infrastructure

Advancements in healthcare infrastructure, including better diagnostic tools and treatment protocols, have improved the management of hypertension and related conditions. This evolution supports the continued growth of the spironolactone and hydrochlorothiazide market[3].

Regulatory Landscape

The regulatory landscape plays a crucial role in shaping the market. Changes in regulatory policies and guidelines can impact the approval and prescription of spironolactone and hydrochlorothiazide. For instance, the British Hypertension Society guidelines recommend spironolactone as fourth-line therapy for uncontrolled hypertension, which has supported its widespread use[4].

Economic Conditions

Fluctuations in economic conditions can affect the market's growth trajectory. Economic downturns may impact healthcare spending, while economic growth can lead to increased investment in healthcare and pharmaceuticals[3].

Financial Trajectory

Current Market Size and Growth

The spironolactone tablets market has experienced remarkable growth in recent years, driven by the rising prevalence of hypertension and heart-related disorders. The market size is expected to continue growing, fueled by increasing awareness, research advancements, and expanding opportunities[3].

Revenue Generation

The revenue generated from spironolactone and hydrochlorothiazide sales is substantial and continues to grow. The drug's effectiveness and the lack of significant side effects, aside from gynecomastia and hyperkalemia in some cases, have made it a preferred choice among physicians, contributing to its financial success[1][4].

Future Outlook

The future outlook for the spironolactone and hydrochlorothiazide market remains promising. With ongoing research and development, innovative drug formulations, and expanding market opportunities, the market is expected to continue its upward trajectory. The adoption of a personalized medicine approach and the focus on untapped markets are likely to further drive growth[3].

Key Trends

Technological Advancements

Technological advancements in drug development and delivery systems are key trends shaping the market. Innovations such as extended-release formulations and improved patient compliance mechanisms are expected to enhance the market's growth[3].

Regulatory Changes

Regulatory changes and updates in clinical guidelines are crucial trends. For example, the recommendation of spironolactone as fourth-line therapy for uncontrolled hypertension has significantly impacted its prescription rates[4].

Market Consolidation

Market consolidation through mergers and acquisitions is another trend. Pharmaceutical companies are increasingly looking to expand their portfolios by acquiring or partnering with other companies that have promising antihypertensive medications[3].

SWOT Analysis

Strengths

  • Effective Therapeutic Benefits: Spironolactone and hydrochlorothiazide have proven efficacy in managing hypertension and related conditions.
  • Wide Prescription Base: The drugs are widely prescribed due to their antihypertensive and diuretic effects.
  • Off-Label Use: The drugs have additional uses, such as treating hormonal acne and PCOS, which expands their market reach.

Weaknesses

  • Side Effects: Gynecomastia and hyperkalemia are notable side effects that can affect patient compliance.
  • Regulatory Restrictions: Historical regulatory restrictions, such as those in the UK, have impacted the drug's use in certain contexts[4].

Opportunities

  • Expanding Markets: Untapped regions with high prevalence of hypertension offer significant growth opportunities.
  • Innovative Formulations: Developing new formulations can enhance patient compliance and market penetration.
  • Collaborations: Strategic partnerships can improve distribution and awareness.

Threats

  • Competing Medications: The availability of alternative antihypertensive medications can pose a threat.
  • Economic Fluctuations: Economic downturns can impact healthcare spending and pharmaceutical sales.

Conclusion

The market for spironolactone and hydrochlorothiazide is robust and growing, driven by the increasing prevalence of hypertension, expanding awareness of the drug's therapeutic benefits, and innovative drug formulations. Despite some challenges, the future outlook remains promising, with significant opportunities for market expansion and revenue growth.

Key Takeaways

  • Growing Demand: The increasing prevalence of hypertension and heart-related disorders drives the demand for spironolactone and hydrochlorothiazide.
  • Therapeutic Efficacy: The combination of spironolactone and hydrochlorothiazide is highly effective in managing hypertension and reducing cardiovascular risk.
  • Market Opportunities: Expanding into untapped markets, developing innovative formulations, and strategic collaborations offer significant growth opportunities.
  • Regulatory Landscape: Changes in regulatory policies and guidelines can impact the market's growth trajectory.
  • Future Outlook: The market is expected to continue growing, driven by evolving healthcare dynamics and a growing global population in need of effective cardiovascular medications.

FAQs

Q: What are the primary uses of spironolactone and hydrochlorothiazide?

A: Spironolactone and hydrochlorothiazide are primarily used to treat high blood pressure and fluid retention. They may also be used to reduce swelling related to heart, kidney, or liver disease[5].

Q: How do spironolactone and hydrochlorothiazide work?

A: Spironolactone acts as an aldosterone receptor antagonist, reducing sodium reabsorption and potassium excretion in the kidneys. Hydrochlorothiazide inhibits sodium and water reabsorption in the cortical diluting segment of the distal renal tubule, enhancing the diuretic effect[1].

Q: What are the common side effects of spironolactone and hydrochlorothiazide?

A: Common side effects include gynecomastia, breast discomfort, and biochemical abnormalities such as hyperkalemia. Patients should avoid potassium supplements and foods high in potassium to minimize the risk of hyperkalemia[1][4].

Q: Why is spironolactone recommended as fourth-line therapy for hypertension?

A: Spironolactone is recommended as fourth-line therapy because it effectively lowers blood pressure in patients whose hypertension is not controlled by other medications. Studies have shown significant reductions in systolic and diastolic blood pressure with spironolactone treatment[4].

Q: What are the market opportunities for spironolactone and hydrochlorothiazide?

A: Market opportunities include expanding into untapped regions, developing innovative drug formulations, focusing on pediatric use, and forming strategic collaborations with healthcare providers and pharmaceutical companies[3].

Sources

  1. Pfizer: Spironolactone and Hydrochlorothiazide Tablets.
  2. Archives of Medical Science: Association of spironolactone treatment and arterial stiffness and cardiovascular disease.
  3. MarkWide Research: Spironolactone Tablets market 2024-2032 | Size, Share, Growth.
  4. American Heart Association Journals: Effect of Spironolactone on Blood Pressure in Subjects With Resistant Hypertension.
  5. Cleveland Clinic: Spironolactone Hydrochlorothiazide: Uses & Side Effects.

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