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Last Updated: December 23, 2024

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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Which patents cover Candesartan Cilexetil And Hydrochlorothiazide, and when can generic versions of Candesartan Cilexetil And Hydrochlorothiazide launch?

Candesartan Cilexetil And Hydrochlorothiazide is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, and Zydus Lifesciences. and is included in six NDAs.

The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Candesartan Cilexetil And Hydrochlorothiazide

A generic version of CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE was approved as candesartan cilexetil; hydrochlorothiazide by MYLAN on December 4th, 2012.

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

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

SponsorPhase
GlaxoSmithKlinePhase 1
TakedaPhase 4
Takeda

See all CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

US Patents and Regulatory Information for CANDESARTAN CILEXETIL 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 Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884-001 Dec 4, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Lifesciences CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 203466-003 Nov 27, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-001 Feb 27, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202965-001 Jun 3, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704-003 Dec 4, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-002 Feb 27, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Lifesciences CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 203466-001 Nov 27, 2017 AB RX 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

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Candesartan Cilexetil and Hydrochlorothiazide

Introduction

Candesartan cilexetil and hydrochlorothiazide is a combination drug used primarily for the treatment of hypertension, aiming to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global market for candesartan cilexetil, which is a key component of the combination drug, was valued at USD 584.2 million in 2024. This market is projected to grow at a compound annual growth rate (CAGR) of 4.60% from 2024 to 2031, reaching USD 800.4 million by 2031[3].

Regional Analysis

The market is segmented across various regions, each contributing significantly to the overall revenue.

  • North America: Held more than 40% of the global revenue with a market size of USD 233.68 million in 2024. It is expected to grow at a CAGR of 2.8% from 2024 to 2031[3].
  • Europe: Accounted for over 30% of the global revenue with a market size of USD 175.26 million in 2024, expected to grow at a CAGR of 3.1% from 2024 to 2031[3].
  • Asia Pacific: Contributed around 23% of the global revenue with a market size of USD 134.37 million in 2024, expected to grow at a CAGR of 6.6% from 2024 to 2031[3].
  • Latin America: Held more than 5% of the global revenue with a market size of USD 29.21 million in 2024, expected to grow at a CAGR of 4.0% from 2024 to 2031[3].
  • Middle East and Africa: Accounted for around 2% of the global revenue with a market size of USD 11.68 million in 2024, expected to grow at a CAGR of 4.3% from 2024 to 2031[3].

Key Drivers

Several factors drive the growth of the candesartan cilexetil and hydrochlorothiazide market:

  • Increasing Incidence of Hypertension: The widespread prevalence of hypertension globally necessitates long-term medication use, contributing to sustained demand for candesartan cilexetil and hydrochlorothiazide[3].
  • Rising Awareness About Cardiovascular Health: Growing awareness about cardiovascular health and the importance of managing blood pressure drives the adoption of these medications.
  • Advancements in Drug Delivery: Improvements in drug delivery systems and formulations enhance the efficacy and patient compliance, further boosting market growth.

Therapeutic Categories

The market is segmented into several therapeutic categories, with hypertension being the dominant category due to its high prevalence. Other significant categories include:

  • Hypertension: The primary indication for candesartan cilexetil and hydrochlorothiazide, driven by the need for effective blood pressure management[3].
  • Diabetic Nephropathy: This category is growing rapidly due to the increasing incidence of diabetes worldwide. Candesartan cilexetil is effective in managing renal function and reducing proteinuria in diabetic patients[3].

Competitive Landscape

The market for candesartan cilexetil and hydrochlorothiazide is competitive, with several major players:

  • AstraZeneca: One of the leading manufacturers of candesartan cilexetil and hydrochlorothiazide combination tablets[1].
  • ANI Pharmaceuticals: Known for its generic versions of the drug.
  • TEVA: A significant player in the generic pharmaceutical market.
  • Mylan: Offers generic and branded versions of the combination drug.
  • Dr. Reddy's Laboratories: Another major player in the generic pharmaceutical sector[1].

Clinical Efficacy and Safety

The combination of candesartan cilexetil and hydrochlorothiazide has been shown to be highly effective in lowering blood pressure. Clinical trials have demonstrated significant reductions in sitting systolic and diastolic blood pressures, with the full antihypertensive effect observed within 4 weeks of treatment[2].

Regulatory and Dosage Considerations

The drug's safety and effectiveness have been established in patients with mild to moderate renal impairment, but not in those with severe renal impairment. No dose adjustment is required for patients with mild or moderate renal impairment, but it is not recommended for initiation in patients with moderate hepatic impairment[2].

Market Trends and Opportunities

  • Growing Demand for Combination Therapies: The combination of candesartan cilexetil and hydrochlorothiazide offers a convenient and effective treatment option, driving its adoption.
  • Expanding Patient Population: Increasing incidence of hypertension and diabetic nephropathy expands the potential patient base.
  • Emerging Markets: Regions like Asia Pacific and Latin America offer significant growth opportunities due to their large and growing populations[3].

Challenges and Restraints

  • Generic Competition: The presence of generic versions of the drug can reduce the market share of branded products.
  • Side Effects and Safety Concerns: Monitoring patients with impaired hepatic function or progressive liver disease is crucial, as minor alterations in fluid and electrolyte balance can precipitate hepatic coma[2].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the pharmaceutical market. While it has disrupted supply chains and manufacturing, it has also highlighted the importance of managing chronic conditions like hypertension, potentially increasing demand for medications like candesartan cilexetil and hydrochlorothiazide[1].

Key Takeaways

  • The global candesartan cilexetil market is projected to grow significantly, driven by increasing hypertension prevalence and advancements in drug delivery.
  • Regional markets, especially in North America, Europe, and Asia Pacific, are key contributors to the overall revenue.
  • The combination of candesartan cilexetil and hydrochlorothiazide is clinically effective and safe for most patients, with some considerations for renal and hepatic impairment.
  • Market trends favor combination therapies, and emerging markets offer substantial growth opportunities.

FAQs

Q: What is the primary indication for candesartan cilexetil and hydrochlorothiazide? A: The primary indication is for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events.

Q: Which regions are the major contributors to the global candesartan cilexetil market? A: North America, Europe, and Asia Pacific are the major contributors, with North America holding over 40% of the global revenue.

Q: What is the projected CAGR for the global candesartan cilexetil market from 2024 to 2031? A: The market is expected to grow at a CAGR of 4.60% from 2024 to 2031.

Q: How does the combination of candesartan cilexetil and hydrochlorothiazide affect blood pressure? A: The combination results in significant reductions in sitting systolic and diastolic blood pressures, with the full effect observed within 4 weeks of treatment.

Q: Are there any specific dosage considerations for patients with renal or hepatic impairment? A: Yes, no dose adjustment is required for patients with mild or moderate renal impairment, but it is not recommended for initiation in patients with moderate hepatic impairment.

Sources:

  1. Global Candesartan and Hydrochlorothiazide Market 2019 Trends, Segmentation, Swot Analysis, Opportunities And Forecast To 2025 - OpenPR
  2. Candesartan Cilexetil and Hydrochlorothiazide tablet - DailyMed
  3. Global Candesartan Cilexetil Market Report 2024 - Cognitive Market Research
  4. Global Candesartan and Hydrochlorothiazide Market Report 2024 - Cognitive Market Research

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