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Last Updated: December 22, 2024

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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When do Quinapril Hydrochloride And Hydrochlorothiazide patents expire, and when can generic versions of Quinapril Hydrochloride And Hydrochlorothiazide launch?

Quinapril Hydrochloride And Hydrochlorothiazide is a drug marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Norvium Bioscience, and Sun Pharm Inds Ltd. and is included in six NDAs.

The generic ingredient in QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; quinapril hydrochloride. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; quinapril hydrochloride profile page.

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Summary for QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
US Patents:0
Applicants:6
NDAs:6
Finished Product Suppliers / Packagers: 4
Clinical Trials: 7
What excipients (inactive ingredients) are in QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE?QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE at DailyMed
Drug patent expirations by year for QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Recent Clinical Trials for QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

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

SponsorPhase
LaborMed Pharma S.A.Phase 4
Vanderbilt University Medical CenterPhase 4
National Center for Research Resources (NCRR)Phase 4

See all QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

US Patents and Regulatory Information for QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 091524-001 Mar 12, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 078211-003 Mar 4, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 076374-001 Mar 31, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 078450-001 Aug 24, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Invagen Pharms QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 201356-003 Apr 20, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 076374-002 Mar 31, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Ltd QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 078211-001 Mar 4, 2009 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

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quinapril Hydrochloride and Hydrochlorothiazide

Introduction

Quinapril hydrochloride and hydrochlorothiazide are key components of antihypertensive drugs, often combined in fixed-dose formulations to treat hypertension. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global antihypertensive drugs market, which includes quinapril hydrochloride and hydrochlorothiazide, is substantial and growing. As of 2023, the market size was valued at USD 22.60 billion and is projected to reach USD 33.49 billion by 2032, growing at a CAGR of 3.87%[4].

Key Drivers of Market Growth

Several factors drive the growth of the market for quinapril hydrochloride and hydrochlorothiazide:

Increasing Prevalence of Hypertension

The rising number of patients suffering from hypertension globally is a significant driver. According to the WHO, approximately 1.13 billion people suffer from hypertension, and this number is expected to increase to 29% by 2025, particularly in economically developing nations[1].

Aging Population

The increase in the geriatric population also boosts the market growth, as older individuals are more likely to develop hypertension and other cardiovascular diseases[1].

Healthcare Expenditure and R&D

Increased healthcare expenditure and research & development activities by pharmaceutical companies contribute to market growth. The launch of novel drugs and formulations further propels the market[1].

Combination Therapy Benefits

The combination of quinapril hydrochloride and hydrochlorothiazide offers enhanced antihypertensive effects compared to monotherapy, making it a preferred treatment option. This combination reduces the risk of fatal and nonfatal cardiovascular events, such as strokes and myocardial infarctions[3].

Market Trends

New Product Launches

The market is driven by the launch of new and innovative drug formulations. For instance, fixed-combination tablets like Accuretic (quinapril HCl/hydrochlorothiazide) have been widely adopted due to their convenience and efficacy[2][3].

Regional Market Dynamics

North America is the largest market shareholder for antihypertensive drugs, driven by the demand for rapid and precise diagnosis and treatment, advanced healthcare facilities, and the need to manage hypertension prognosis. The Asia Pacific region is expected to be the fastest-growing market due to increasing healthcare awareness and infrastructure development[4].

Challenges and Restraints

Side Effects and Safety Concerns

Side effects associated with hydrochlorothiazide, such as electrolyte imbalances and potential kidney issues, can hamper market growth. Additionally, recalls due to impurities, such as the N-Nitroso-Quinapril content in some lots of Accuretic tablets, can impact consumer confidence and market expansion[4][5].

Regulatory Issues

Product recalls, as seen in the case of Pfizer's voluntary recall of Accuretic tablets in 2022, can temporarily slow market growth. Such recalls are often due to impurities or adverse effects, which can lead to regulatory scrutiny and consumer skepticism[5].

Pharmacokinetics and Pharmacodynamics

Absorption and Metabolism

Quinapril hydrochloride is absorbed within 1 hour, with an extent of absorption of at least 60%. Hydrochlorothiazide absorption is slower (1 to 2.5 hours) but more complete (50% to 80%). Quinapril is deesterified to its active metabolite, quinaprilat, while hydrochlorothiazide is not metabolized and is excreted unchanged by the kidneys[2][3].

Elimination and Half-Life

The elimination half-life of quinaprilat is approximately 2 hours with a prolonged terminal phase, while hydrochlorothiazide has a plasma half-life varying between 4 to 15 hours. In patients with renal insufficiency, the elimination half-life of both drugs is prolonged[2][3].

Competitive Landscape

The market for quinapril hydrochloride and hydrochlorothiazide is competitive, with several key players including:

  • Beijing Second Pharmaceutical
  • Torrent Pharmaceuticals
  • Zhejiang Huahai Pharmaceutical
  • Teva
  • Cisen Pharmaceutical
  • Par Pharmaceutical
  • Aurobindo Pharma
  • Chongqing Conquer Pharmaceutical
  • Novartis
  • Alembic Pharmaceuticals
  • Mylan
  • Huaren Pharmaceutical
  • MACLEODS
  • APOTEX
  • Lupin[1].

Financial Projections

Given the growing demand for antihypertensive drugs and the specific benefits of quinapril hydrochloride and hydrochlorothiazide combination therapy, the financial trajectory for these drugs is positive. The market is expected to continue growing, driven by increasing prevalence of hypertension, aging population, and advancements in healthcare.

Key Takeaways

  • The global antihypertensive drugs market, including quinapril hydrochloride and hydrochlorothiazide, is projected to grow significantly by 2032.
  • Key drivers include the increasing prevalence of hypertension, aging population, and increased healthcare expenditure.
  • Combination therapy with quinapril hydrochloride and hydrochlorothiazide offers enhanced antihypertensive effects.
  • Side effects and safety concerns, along with regulatory issues, are potential restraints.
  • The competitive landscape is diverse with multiple key players.

FAQs

Q: What is the primary indication for quinapril hydrochloride and hydrochlorothiazide combination therapy? A: The primary indication is for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events[3].

Q: How does the combination of quinapril and hydrochlorothiazide affect serum potassium levels? A: The combination tends to reduce the potassium loss associated with hydrochlorothiazide monotherapy, resulting in a milder reduction in serum potassium levels[2][3].

Q: What are the potential side effects of hydrochlorothiazide? A: Hydrochlorothiazide can cause side effects such as electrolyte imbalances, potential kidney issues, and other adverse effects that may hamper market growth[1].

Q: Why was there a recall of Accuretic tablets in 2022? A: The recall was due to elevated levels of N-Nitroso-Quinapril, a potentially cancer-causing impurity[5].

Q: Which region is expected to be the fastest-growing market for antihypertensive drugs? A: The Asia Pacific region is expected to be the fastest-growing market due to increasing healthcare awareness and infrastructure development[4].

Cited Sources

  1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
  2. FDA: Accuretic (quinapril HCI/hydrochlorothiazide) tablet label
  3. Pfizer: Quinapril and hydrochlorothiazide Tablets
  4. Straits Research: Global Antihypertensive Drugs Market Size, Top Share, Forecast to ...
  5. Pfizer: Pfizer Voluntary Nationwide Recall of Lots of ACCURETICâ„¢ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content

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