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Last Updated: December 22, 2024

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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

Spironolactone And Hydrochlorothiazide is a drug marketed by Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, and Watson Labs. and is included in eight NDAs.

The generic ingredient in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; spironolactone. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; spironolactone profile page.

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Summary for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
US Patents:0
Applicants:8
NDAs:8
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 5
Clinical Trials: 9
Patent Applications: 30
What excipients (inactive ingredients) are in SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE?SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE at DailyMed
Drug patent expirations by year for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Recent Clinical Trials for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

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 SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Drug ClassAldosterone Antagonist
Thiazide Diuretic
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascot SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 088025-001 Nov 23, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Superpharm SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 089137-001 Aug 26, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 086513-001 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 087398-001 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

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Spironolactone and Hydrochlorothiazide

Market Overview

The market for Spironolactone and Hydrochlorothiazide, two diuretic agents used in combination to treat high blood pressure and edema, is influenced by several key factors.

Growing Prevalence of Hypertension and Cardiovascular Disorders

The increasing incidence of hypertension and related heart conditions globally has been a significant driver for the market. As the population ages and the prevalence of these conditions rises, the demand for effective medications like Spironolactone and Hydrochlorothiazide increases[3].

Rising Awareness of Therapeutic Benefits

Growing awareness among healthcare professionals about the therapeutic benefits of Spironolactone, particularly its role in managing edema and heart failure while maintaining potassium levels, has led to higher prescription rates. This increased awareness has contributed to the market's growth[3].

Expanding Off-Label Uses

Spironolactone's off-label use in treating conditions such as hormonal acne and polycystic ovary syndrome (PCOS) has opened up new avenues for market growth. These additional uses have expanded the patient base and increased the drug's demand[3].

Advancements in Drug Formulations

Ongoing research and development to improve drug formulations and delivery systems have enhanced patient compliance and contributed to market expansion. Innovations such as extended-release tablets are expected to further boost the market[3].

Market Drivers

Increasing Aging Population

The global aging population is a significant driver for the Spironolactone and Hydrochlorothiazide market. As people age, the prevalence of hypertension and heart conditions increases, leading to a higher demand for these medications[3].

Combination Therapy Benefits

The combination of Spironolactone and Hydrochlorothiazide provides additive diuretic and antihypertensive effects, making it an effective treatment option for many patients. This combination helps minimize the potassium loss typically associated with thiazide diuretics like Hydrochlorothiazide[4].

Market Opportunities

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 treatment options are limited. Targeting these untapped markets can drive further growth[3].

Innovative Drug Formulations

The development of innovative drug formulations, such as extended-release tablets, can enhance patient compliance and open up new market opportunities. These advancements can improve the efficacy and convenience of the medication, attracting more patients and healthcare providers[3].

Focus on Pediatric Use

Exploring the effectiveness and safety of Spironolactone in the pediatric population could create new growth avenues for the market. This could involve clinical trials and regulatory approvals to expand the drug's indications[3].

Collaborations and Partnerships

Strategic collaborations with healthcare providers, pharmaceutical companies, and research institutions can enhance market penetration and promote the drug’s usage. These partnerships can also drive innovation and improve 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 and heart conditions. These changes require continuous adaptation in treatment strategies and drug formulations[3].

Evolving Healthcare Infrastructure

Advancements in healthcare infrastructure, including better diagnostic tools and treatment facilities, have improved the management of hypertension and related conditions. This evolution supports the increased use of Spironolactone and Hydrochlorothiazide[3].

Regulatory Landscape

The regulatory landscape plays a crucial role in the market dynamics. Changes in regulations and guidelines can impact the approval and prescription of these medications. For instance, the FDA's monitoring of side effects and the requirement for careful dosing to avoid hyperkalemia are critical factors[2].

Financial Trajectory

Cost and Pricing

The cost of Spironolactone and Hydrochlorothiazide can vary significantly depending on the brand and generic versions. Generic versions of both drugs are generally more affordable, with Hydrochlorothiazide often being less expensive than Spironolactone on a per-day basis. For example, a month's supply of generic Hydrochlorothiazide can cost as low as $0.05 per day, while generic Spironolactone can cost around $0.45 per day[1].

Market Size and Growth

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

Revenue Generation

The revenue generated from Spironolactone and Hydrochlorothiazide is substantial, given their widespread use. In 2020, Hydrochlorothiazide was prescribed to approximately 8 million people in the US, accounting for around 20% of diuretic prescriptions. Spironolactone, including its branded versions, was prescribed to about 3 million people in the same period, accounting for over 15% of potassium-sparing diuretic prescriptions[1].

Key Takeaways

  • The market for Spironolactone and Hydrochlorothiazide is driven by the growing prevalence of hypertension and cardiovascular disorders.
  • The combination therapy offers additive diuretic and antihypertensive effects, making it an effective treatment option.
  • Expanding off-label uses and advancements in drug formulations contribute to market growth.
  • The market has significant opportunities in untapped regions and through innovative drug formulations.
  • The financial trajectory is influenced by the cost and pricing of the medications, with generic versions being more affordable.

FAQs

Q: What are the primary uses of Spironolactone and Hydrochlorothiazide? A: These medications are primarily used to treat high blood pressure, edema due to various conditions such as heart, liver, or kidney disease, and to manage conditions like primary hyperaldosteronism and hypokalemia[1][2].

Q: How do Spironolactone and Hydrochlorothiazide work? A: Spironolactone works by blocking aldosterone receptors, reducing sodium reabsorption and sparing potassium. Hydrochlorothiazide promotes the excretion of sodium and water by inhibiting their reabsorption in the renal tubules[1][4].

Q: What are the potential side effects of Spironolactone and Hydrochlorothiazide? A: Common side effects include nausea, vomiting, diarrhea, loss of appetite, stomach pain, frequent urination, dizziness, and headache. Serious side effects can include muscle weakness, changes in vision, rapid weight loss, and unusual bruising or bleeding[2].

Q: How much do Spironolactone and Hydrochlorothiazide cost? A: The cost varies between brand and generic versions. Generic Hydrochlorothiazide can cost as low as $0.05 per day, while generic Spironolactone can cost around $0.45 per day[1].

Q: What are the market opportunities for Spironolactone and Hydrochlorothiazide? A: Opportunities include expanding into untapped markets, developing innovative drug formulations, focusing on pediatric use, and forming strategic collaborations with healthcare providers and pharmaceutical companies[3].

Sources

  1. Hydrochlorothiazide vs Spironolactone | Power - Clinical Trials
  2. Spironolactone and Hydrochlorothiazide - MedlinePlus
  3. Spironolactone Tablets market 2024-2032 | Size, Share, Growth
  4. Spironolactone and Hydrochlorothiazide Tablets - Pfizer

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