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, Anda Repository, Apotex Inc, 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
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; 25MG	TABLET; ORAL
		32MG; 12.5MG	TABLET; ORAL
		16MG; 12.5MG	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
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-001	Dec 4, 2012	AB	RX	No	No
Mylan	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	090704-003	Dec 4, 2012	AB	RX	No	No
Macleods Pharms Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	204100-002	Feb 27, 2015	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	021093-002	Sep 5, 2000	5,703,110
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-003	May 16, 2008	5,705,517*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	7,538,133*PED

Market Dynamics and Financial Trajectory for Candesartan Cilexetil; Hydrochlorothiazide

Last updated: July 27, 2025

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Introduction

Candesartan cilexetil combined with hydrochlorothiazide (HCTZ) is an established antihypertensive therapy primarily indicated for managing high blood pressure. This fixed-dose combination (FDC) offers enhanced patient compliance and therapeutic efficacy, positioning it within the competitive landscape of cardiovascular drugs. The following analysis explores the market dynamics influencing this pharmaceutical duo and projects its financial trajectory amidst evolving healthcare trends.

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Market Overview

Hypertension remains a formidable global health challenge, affecting over 1 billion individuals worldwide, with prevalence rising due to sedentary lifestyles, dietary factors, and aging populations (WHO, 2021). The demand for effective antihypertensive agents like candesartan cilexetil; HCTZ persists, driven by clinical guidelines that favor combination therapy for refractory cases and to improve adherence.

Candesartan, an angiotensin II receptor blocker (ARB), is favored for its favorable side effect profile compared to older agents like ACE inhibitors. Hydrochlorothiazide, a thiazide diuretic, has a longstanding record of efficacy and cost-effectiveness, often used synergistically with ARBs. The combination formulation exploits complementary mechanisms to optimize blood pressure control.

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Key Drivers of Market Dynamics

1. Clinical Efficacy and Safety Profile

Clinical trials demonstrate that the candesartan-HCTZ combo offers superior blood pressure reduction compared to monotherapy, with a tolerable safety profile. This drives physician preference, especially in cases requiring multidrug regimens, contributing to steady demand.

2. Regulatory Environment and Approvals

Regulatory agencies such as the US FDA and EMA approve fixed-dose combinations to improve compliance. The popularity of candesartan; HCTZ stems from its established safety and efficacy profile. Approvals of generic versions typically accelerate market penetration, making therapy more accessible and expanding patient base.

3. Patent Expiry and Generic Competition

Patents on original formulations are generally set to expire in the mid-2020s, ushering in a wave of generic competitors. Generics significantly reduce prices, affecting branded drug revenues but broadening market access and volume.

4. Pricing and Reimbursement Policies

Healthcare systems worldwide increasingly emphasize cost-effectiveness. Reimbursement approvals for generics and biosimilars propel volumes but exert downward pressure on prices. In regions with robust healthcare coverage, this enhances market penetration.

5. Prescribing Trends and Clinical Guidelines

Guidelines from entities like the American College of Cardiology (ACC) and the European Society of Hypertension recommend combination therapy as first-line treatment in certain patient populations, supporting sustained demand for candesartan; HCTZ.

6. Penetration in Emerging Markets

Emerging economies, notably China, India, and Latin America, exhibit growing hypertension prevalence. Price sensitivity and expanding healthcare infrastructure facilitate adoption of affordable generics, expanding global market reach.

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Financial Trajectory and Market Forecast

Current Market Valuation

The global antihypertensive drug market was valued at approximately USD 21.5 billion in 2021, with ARBs and diuretics accounting for significant shares. Candestartan-containing formulations hold a sizable share within this segment, estimated at USD 1.3 billion in 2022, driven by the combination's steady demand.

Projected Growth Trends (2023–2030)

• Compound Annual Growth Rate (CAGR): The antihypertensive market is projected to expand at a CAGR of approximately 4.8% from 2023 to 2030 (Grand View Research, 2022).
• Key Factors: Increased adoption in emerging markets, aging populations, and shifts toward combination therapies underpin this growth.

Impact of Patent Expirations

As patent exclusivities expire over the next 2–4 years, generic versions are expected to dominate, reducing proprietary revenues. However, this shift broadens access and volume, supporting overall market expansion despite declining margins on branded products.

Innovation and Pipeline Dynamics

While current formulations dominate, pipeline developments include long-acting ARB combinations and novel delivery systems. Such innovations could rejuvenate market interest and provide premium pricing opportunities if regulatory approval is achieved.

Potential Challenges

• Pricing Pressures: Increased competition and policy-driven price controls could compress margins.
• Generic Market Saturation: A proliferation of generics may lead to price erosion post-patent expiry.
• Healthcare Policy Shifts: Focus on cost containment in health systems might favor cheaper, established generics over branded alternatives.

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Regional Market Insights

North America

Dominates due to high hypertension prevalence, advanced healthcare infrastructure, and favorable reimbursement structures. The U.S. market is mature, with generic availability limiting revenue growth but ensuring volume expansion.

Europe

Similar dynamics to North America, with regional regulatory harmonization facilitating access. Market growth is driven by aging populations and updated clinical guidelines.

Asia-Pacific

Expected to experience the fastest growth owing to demographic shifts, increasing hypertension prevalence, and rapidly expanding healthcare access. Price sensitivity favors generics, but local regulatory landscapes may influence market entry strategies.

Emerging Markets

Largely dependent on generics, with governments promoting cost-effective therapies. Market growth is promising but challenged by infrastructural limitations and variable regulatory frameworks.

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Strategic Outlook and Business Implications

• For Pharmaceutical Companies:
  Emphasize R&D for innovative combinations or delivery technologies to sustain premium pricing. Invest in cost-efficient manufacturing to remain competitive post-generic entry. Strategic alliances and licensing in emerging markets enhance reach.

• For Investors:
  Monitor patent expiries and regulatory approvals. Diversify portfolio with pipeline candidates and biosimilars. Focus on companies with robust market access strategies.

• For Healthcare Systems:
  Promote generic substitution and formulary inclusion to optimize resource allocation. Support adherence programs leveraging combination therapies to reduce long-term costs related to uncontrolled hypertension.

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Key Takeaways

• The combination of candesartan cilexetil and hydrochlorothiazide remains a mainstay in hypertension management, with enduring clinical relevance fueling consistent demand.
• Patent expirations projected within the next few years will significantly increase generic competition, exerting downward pressure on prices but expanding access.
• Market growth is driven by demographic shifts, adherence to clinical guidelines favoring combination therapy, and emerging markets' expanding healthcare infrastructure.
• Innovative formulations and pipeline developments could provide growth opportunities amid price erosion.
• Strategic positioning in emerging markets, cost management, and ongoing R&D are vital for manufacturers aiming to sustain financial performance.

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FAQs

Q1: How will patent expiries impact the profitability of candesartan; HCTZ formulations?
A: Patent expiries will open the market to generics, reducing prices and profit margins for branded formulations. While revenues may decline initially, overall market volume could increase, offsetting some losses.

Q2: What growth opportunities exist for pharmaceutical companies post-generic entry?
A2: Companies can focus on developing new fixed-dose combinations with longer-acting components, improved delivery systems, or adjunct therapies. Market expansion in emerging economies and strategic licensing are also avenues.

Q3: Are there concerns regarding safety or efficacy that could influence future adoption of candesartan; HCTZ?
A: The safety profile remains well-established; however, evolving clinical guidelines or new comparative studies may influence prescribing patterns, favoring or disfavoring combinations.

Q4: How significant is the role of healthcare policy in shaping the market trajectory?
A: Policies emphasizing cost containment and promoting generic substitution exert considerable influence, often accelerating market penetration of generic drugs and affecting pricing strategies.

Q5: What pharmacovigilance considerations are associated with long-term use of candesartan; HCTZ?
A: Monitoring for electrolyte imbalances, renal function, and adverse cardiovascular events remains essential, especially as widespread use increases. Ongoing safety surveillance supports confidence in long-term therapy.

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References

[1] World Health Organization. (2021). Hypertension Fact Sheet.
[2] Grand View Research. (2022). Antihypertensive Drugs Market Analysis.
[3] Latest clinical guidelines from ACC and European Society of Hypertension.