CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Candesartan cilexetil; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, and Zydus Lifesciences, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	16
DailyMed Link:	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
Takeda	Phase 4
Takeda

See all CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant	Application No.	Strength	Dosage Form
		32MG; 12.5MG	TABLET; ORAL
		16MG; 12.5MG	TABLET; ORAL
		32MG; 25MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	32 mg/25 mg	021093	1	2009-03-06
ATACAND HCT	Tablets	candesartan cilexetil; hydrochlorothiazide	16 mg/12.5 mg and 32 mg/12.5 mg	021093	1	2008-06-25

US Patents and Regulatory Information for CANDESARTAN CILEXETIL; 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	202884-003	Jun 3, 2013		DISCN	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-001	Dec 4, 2012	AB	RX	No	No
Zydus Lifesciences	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	203466-001	Nov 27, 2017	AB	RX	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-002	Dec 4, 2012	AB	RX	No	No

Expired US Patents for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Candesartan Cilexetil and Hydrochlorothiazide

Introduction

Candesartan cilexetil and hydrochlorothiazide, often combined as Atacand HCT, are pivotal in the management of hypertension. This combination therapy has garnered significant attention due to its efficacy and market presence. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global market for candesartan cilexetil, including its combination with hydrochlorothiazide, is projected to experience substantial growth. As of 2023, the global market size for candesartan cilexetil was estimated to be worth US$ 548 million. It is forecasted to reach US$ 793.2 million by 2030, with a compound annual growth rate (CAGR) of 6.1% during the forecast period of 2024-2030[3].

Segmentation and Application

The market for candesartan cilexetil and hydrochlorothiazide is segmented based on type, application, and region. The combination is primarily used for the management of hypertension, with the 16/12.5 mg dose being a significant segment that is expected to experience significant growth in the near future. The adult segment is also anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1].

Regional Analysis

The market is segmented into major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region provides insights into revenue share, current trends, and future market opportunities. The regional analysis helps in understanding the global, regional, and country-level insights, which are crucial for making informed business decisions[1].

Competitor Analysis

Key companies such as AstraZeneca, TEVA, ANI Pharmaceuticals, Mylan, Zydus Pharmaceuticals, and others are actively involved in the market. AstraZeneca, for instance, has divested the commercial rights of Atacand and Atacand Plus to Cheplapharm in over 70 countries, receiving a total payment of $400 million. This move reflects the strategic shifts and competitive dynamics within the industry[2].

Financial Considerations

The divestment of Atacand and Atacand Plus by AstraZeneca to Cheplapharm involved significant financial transactions. AstraZeneca received $250 million upfront and an additional $150 million in non-contingent payments during the first half of 2021. This transaction highlights the financial value and strategic importance of these drugs in the market[2].

Market Drivers and Opportunities

Several factors drive the growth of the candesartan cilexetil and hydrochlorothiazide market. The increasing prevalence of hypertension, the efficacy of the combination therapy, and the expanding aging population are key drivers. Additionally, the combination's ability to provide a more significant antihypertensive effect compared to monotherapy with either drug alone presents a significant market opportunity[5].

Market Restraints

Despite the growth potential, there are restraints to consider. These include the need for continuous monitoring of patients with hepatic impairment, as the pharmacokinetics of candesartan can be significantly affected in such cases. Thiazide diuretics should also be used with caution in patients with hepatic impairment, which can limit the market growth to some extent[4].

ESG and Regulatory Analysis

The market is influenced by environmental, social, and governance (ESG) factors, as well as regulatory requirements. Companies must adhere to stringent regulatory standards, and ESG considerations play a crucial role in the long-term sustainability of their operations. The report provides an in-depth ESG analysis to help businesses understand these factors better[1].

Technological Trends

Advancements in pharmaceutical technology and manufacturing processes are crucial for the market. The report includes a technological trend analysis, which helps in understanding the latest developments and their impact on the market. This includes improvements in drug formulation, delivery systems, and manufacturing efficiency[1].

SWOT Analysis

A SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) is essential for understanding the market position and future prospects. The strengths include the efficacy of the combination therapy and the strong market presence of key players. Weaknesses might include the dependency on a few key manufacturers and the potential side effects associated with the drugs. Opportunities lie in expanding into new markets and leveraging the growing demand for antihypertensive treatments. Threats could include competition from generic drugs and regulatory changes[1].

COVID-19 Impact

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the market for candesartan cilexetil and hydrochlorothiazide. The report provides a COVID-19 analysis, highlighting how the pandemic has affected supply chains, manufacturing, and consumer behavior. This analysis is crucial for understanding the current market dynamics and future recovery prospects[1].

Consumer Behavior Analysis

Consumer behavior plays a vital role in shaping the market. The report includes an analysis of consumer behavior, which helps in understanding patient preferences, adherence to treatment, and the impact of healthcare policies on drug consumption. This insights are essential for marketing strategies and product positioning[1].

Key Takeaways

• Market Growth: The global market for candesartan cilexetil and hydrochlorothiazide is expected to grow significantly, reaching US$ 793.2 million by 2030.
• Segmentation: The market is segmented by type, application, and region, with the adult segment and 16/12.5 mg dose being key segments.
• Competitive Landscape: Major players like AstraZeneca and TEVA are actively involved, with strategic divestments and expansions.
• Financial Trajectory: Significant financial transactions, such as AstraZeneca's divestment to Cheplapharm, highlight the market's financial value.
• Drivers and Restraints: Increasing hypertension prevalence and the combination's efficacy drive the market, while hepatic impairment considerations act as restraints.

FAQs

Q: What is the projected market size for candesartan cilexetil by 2030? A: The global market for candesartan cilexetil is forecasted to reach US$ 793.2 million by 2030[3].

Q: Which companies are key players in the candesartan cilexetil and hydrochlorothiazide market? A: Key companies include AstraZeneca, TEVA, ANI Pharmaceuticals, Mylan, and Zydus Pharmaceuticals[1][3].

Q: What was the financial consideration for AstraZeneca's divestment of Atacand and Atacand Plus? A: AstraZeneca received a total payment of $400 million from Cheplapharm[2].

Q: How does the combination of candesartan cilexetil and hydrochlorothiazide compare to monotherapy? A: The combination is significantly more efficacious than either drug alone in reducing blood pressure[5].

Q: What are the potential restraints for the market growth of candesartan cilexetil and hydrochlorothiazide? A: The need for caution in patients with hepatic impairment and potential side effects are key restraints[4].

Cited Sources

1. Global Candesartan and Hydrochlorothiazide Market Report 2024 - Cognitive Market Research
2. Atacand divestment to Cheplapharm in more than 70 countries completed - AstraZeneca
3. Candesartan Cilexetil Drug - Market Size - Valuates Reports
4. Atacand HCT (candesartan cilexetil-hydrochlorothiazide) tablets label - FDA
5. Candesartan cilexetil plus hydrochlorothiazide combination - PubMed