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Last Updated: December 22, 2024

ALDACTAZIDE Drug Patent Profile


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When do Aldactazide patents expire, and what generic alternatives are available?

Aldactazide is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ALDACTAZIDE 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 ALDACTAZIDE
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Pharmacology for ALDACTAZIDE
Drug ClassAldosterone Antagonist
Thiazide Diuretic
Mechanism of ActionAldosterone Antagonists
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for ALDACTAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer ALDACTAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 012616-004 Dec 30, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer ALDACTAZIDE hydrochlorothiazide; spironolactone TABLET;ORAL 012616-005 Dec 30, 1982 DISCN Yes 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

ALDACTAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ALDACTAZIDE

Introduction

ALDACTAZIDE, a combination drug containing spironolactone and hydrochlorothiazide, is widely used for the treatment of various conditions including edematous states, congestive heart failure, and hypertension. Understanding the market dynamics and financial trajectory of ALDACTAZIDE is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The market for ALDACTAZIDE is part of the broader diuretics and antihypertensive drugs market. This segment has seen steady growth due to increasing prevalence of cardiovascular diseases and hypertension.

Key Indications and Usage

ALDACTAZIDE is indicated for several conditions:

  • Edematous Conditions: For patients with congestive heart failure, ALDACTAZIDE is used to manage edema and sodium retention when other therapeutic measures are inadequate or inappropriate[4].
  • Hypertension: It is used to lower blood pressure in patients where other measures are considered inadequate or inappropriate[4].
  • Diuretic-Induced Hypokalemia: ALDACTAZIDE treats hypokalemia in patients with congestive heart failure or hypertension when other measures are inappropriate[4].

Mechanism of Action

The drug combines the effects of spironolactone, an aldosterone antagonist, and hydrochlorothiazide, a thiazide diuretic. This combination provides additive diuretic and antihypertensive effects, minimizing potassium loss associated with thiazide diuretics[4].

Market Growth Drivers

Several factors drive the market growth for ALDACTAZIDE:

  • Increasing Prevalence of Cardiovascular Diseases: The rising incidence of heart failure and hypertension globally increases the demand for effective antihypertensive and diuretic medications[1].
  • Aging Population: An aging population is more prone to cardiovascular diseases, further boosting the demand for ALDACTAZIDE[1].
  • Off-Label Use: The popularity of off-label genetic drugs, including those with similar mechanisms to ALDACTAZIDE, can also influence market growth[1].

Competitive Landscape

The market for ALDACTAZIDE is competitive, with several other diuretics and antihypertensive drugs available. Key competitors include other aldosterone antagonists like eplerenone and combination drugs from major pharmaceutical companies such as Pfizer Inc. and Merck & Co., Inc.[1].

Financial Performance

Sales Trends

  • The sales of ALDACTAZIDE, while not explicitly stated, can be inferred from the broader market trends. Diuretics and antihypertensive drugs generally show steady sales growth, with some drugs reaching peak sales several years after market approval[3].
  • For example, drugs in the antihypertensive segment can achieve quarterly sales ranging from $5 to $40 million after a few years on the market, with top performers reaching much higher figures[3].

Revenue Projections

  • The global hirsutism treatment market, which includes some of the same pharmaceutical companies, is projected to grow significantly, indicating a positive trend for related therapeutic areas. For instance, the global hirsutism treatment market is expected to grow by USD 2.23 billion during 2019-2023, with a CAGR of almost 14%[1].
  • While ALDACTAZIDE is not specifically mentioned in these projections, the growth in related therapeutic areas suggests a stable to growing financial trajectory for this drug.

Cost-Effectiveness and Economic Evaluation

  • The cost-effectiveness of ALDACTAZIDE is an important factor in its market dynamics. Studies have shown that aldosterone antagonists like spironolactone can be cost-effective in managing conditions such as post-myocardial infarction heart failure, although the specific cost-effectiveness of ALDACTAZIDE may vary depending on the patient population and treatment duration[2].
  • For instance, a study comparing spironolactone and eplerenone found that eplerenone was generally more cost-effective, but spironolactone could be more cost-effective under certain assumptions[2].

Regulatory and Reimbursement Environment

  • The regulatory and reimbursement environment plays a crucial role in the financial trajectory of ALDACTAZIDE. Drugs that are covered under healthcare programs and have favorable reimbursement policies tend to have higher sales and market penetration.
  • For example, in the Oregon Drug Use Review, ALDACTAZIDE is listed with specific reimbursement guidelines, indicating its inclusion in healthcare programs[5].

Challenges and Limitations

  • Despite its market potential, ALDACTAZIDE faces challenges such as side effects, particularly gynaecomastia associated with spironolactone, and the need for careful patient selection[2][4].
  • The availability of alternative treatments and the ongoing development of new antihypertensive and diuretic drugs also pose competitive challenges.

Future Outlook

The future outlook for ALDACTAZIDE remains positive due to its established efficacy and the growing demand for antihypertensive and diuretic medications. However, the market will continue to be influenced by factors such as regulatory changes, reimbursement policies, and the introduction of new therapies.

Key Takeaways

  • ALDACTAZIDE is a significant player in the diuretics and antihypertensive drugs market.
  • The drug's market growth is driven by increasing prevalence of cardiovascular diseases and an aging population.
  • Cost-effectiveness and reimbursement policies are crucial for its financial trajectory.
  • Despite challenges, ALDACTAZIDE is expected to maintain a stable market presence.

FAQs

Q: What are the primary indications for ALDACTAZIDE? A: ALDACTAZIDE is primarily indicated for edematous conditions, congestive heart failure, and hypertension.

Q: How does ALDACTAZIDE work? A: ALDACTAZIDE combines spironolactone, an aldosterone antagonist, and hydrochlorothiazide, a thiazide diuretic, to provide additive diuretic and antihypertensive effects.

Q: What are the key drivers of the ALDACTAZIDE market? A: The market is driven by the increasing prevalence of cardiovascular diseases, an aging population, and off-label use of similar medications.

Q: How does ALDACTAZIDE compare to other aldosterone antagonists in terms of cost-effectiveness? A: Studies suggest that while eplerenone may be more cost-effective in some scenarios, spironolactone (a component of ALDACTAZIDE) can be cost-effective under certain assumptions.

Q: What are the potential challenges for ALDACTAZIDE in the market? A: Challenges include side effects such as gynaecomastia, the availability of alternative treatments, and ongoing development of new therapies.

Cited Sources

  1. Technavio: Global Hirsutism Treatment Market 2019-2023 | Technavio
  2. NIHR: A systematic review and economic evaluation of the clinical effectiveness and cost-effectiveness of aldosterone antagonists in post-myocardial infarction heart failure
  3. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs
  4. DailyMed: ALDACTAZIDE- spironolactone and hydrochlorothiazide tablet, film coated
  5. Oregon Drug Use Review: Oregon Drug Use Review / Pharmacy & Therapeutics Committee Meeting Documents

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