Candesartan cilexetil - Generic Drug Details

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

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

There are twenty-two drug master file entries for candesartan cilexetil. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for candesartan cilexetil

US Patents:	0
Tradenames:	4
Applicants:	9
NDAs:	15
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	68
Patent Applications:	6,807
Drug Prices:	Drug price trends for candesartan cilexetil
What excipients (inactive ingredients) are in candesartan cilexetil?	candesartan cilexetil excipients list
DailyMed Link:	candesartan cilexetil at DailyMed

See drug prices for candesartan cilexetil

Recent Clinical Trials for candesartan cilexetil

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

Sponsor	Phase
University of California, San Francisco	Phase 2
United States Department of Defense	Phase 2
University of Sydney	Phase 2

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL

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

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for candesartan cilexetil

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATACAND	Tablets	candesartan cilexetil	4 mg, 8 mg, 16 mg and 32 mg	020838	1	2006-12-22

US Patents and Regulatory Information for candesartan cilexetil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	210302-002	Dec 4, 2018	AB	RX	No	No
Dr Reddys Labs Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202965-001	Jun 3, 2013	AB	RX	No	No
Prinston Inc	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	207455-001	Apr 11, 2018	AB	RX	No	No
Macleods Pharms Ltd	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	203813-003	Dec 5, 2016	AB	RX	No	No
Dr Reddys Labs Ltd	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	202965-002	Jun 3, 2013	AB	RX	No	No

Expired US Patents for candesartan cilexetil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	5,196,444*PED
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	7,538,133*PED
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-003	Jun 4, 1998	5,703,110
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	5,196,444*PED
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-002	Jun 4, 1998	5,705,517*PED

Candesartan cilexetil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Candesartan Cilexetil

Introduction

Candesartan cilexetil, a selective angiotensin II receptor antagonist, is a widely used medication for the treatment of hypertension and heart failure. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key trends, growth drivers, and regional performances.

Global Market Size and Growth

As of 2024, the global candesartan cilexetil market size is estimated to be USD 584.2 million. 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[1].

Regional Market Performance

North America

North America holds the largest share of the global candesartan cilexetil market, with a market size of USD 233.68 million in 2024. This region is expected to grow at a CAGR of 2.8% from 2024 to 2031. The United States is the dominant market within North America, with a market size of USD 184.37 million in 2024 and a CAGR of 2.6% over the forecast period[1].

Europe

Europe accounts for more than 30% of the global revenue, with a market size of USD 175.26 million in 2024. The European market is anticipated to grow at a CAGR of 3.1% from 2024 to 2031. The divestment of commercial rights for Atacand (candesartan cilexetil) to Cheplapharm in Europe has been a significant strategic move, aimed at expanding the commercial potential of the drug in this region[1][2].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 134.37 million in 2024. This region is expected to experience the highest growth rate, with a CAGR of 6.6% from 2024 to 2031. China is a key market within this region, with a market size of USD 60.46 million in 2024 and a CAGR of 6.1% over the forecast period[1].

Latin America and Middle East & Africa

Latin America accounts for more than 5% of the global revenue, with a market size of USD 29.21 million in 2024, and is expected to grow at a CAGR of 4.0% from 2024 to 2031. The Middle East and Africa hold around 2% of the global revenue, with a market size of USD 11.68 million in 2024, and are projected to grow at a CAGR of 4.3% over the same period[1].

Drivers of Market Growth

Increasing Incidence of Hypertension

The rising incidence of hypertension globally is a significant driver for the candesartan cilexetil market. As the population ages and lifestyle factors contribute to higher blood pressure rates, the demand for effective antihypertensive medications like candesartan cilexetil is expected to increase[1].

Advancements in Drug Delivery

Advancements in drug delivery systems and formulations are enhancing the efficacy and patient compliance of candesartan cilexetil. These innovations are likely to boost sales and market growth[1].

Rising Awareness About Cardiovascular Health

Increased awareness about cardiovascular health and the importance of managing hypertension and heart failure is driving the adoption of candesartan cilexetil. Public health initiatives and educational campaigns are contributing to this trend[1].

Competitive Landscape

Key Players

AstraZeneca, the original developer of Atacand (candesartan cilexetil), has divested its commercial rights in Europe to Cheplapharm, a move aimed at leveraging Cheplapharm's strong European presence to expand the drug's commercial potential. This strategic move highlights the competitive dynamics in the market, where companies are seeking partnerships and divestitures to optimize their product portfolios[2].

Clinical Efficacy and Comparisons

Candesartan vs. Losartan

Clinical trials, such as the CANDLE study, have compared the efficacy of candesartan cilexetil with other angiotensin receptor blockers like losartan. The study found that candesartan cilexetil was associated with greater blood pressure reduction compared to losartan, reinforcing its clinical significance and market position[5].

Financial Considerations

Revenue and Sales

In 2017, global product sales for Atacand and Atacand Plus were $300 million, with $86 million generated in Europe. The divestment agreement with Cheplapharm included an upfront payment of $200 million, a time-bound payment of $10 million, and sales-contingent milestones, reflecting the financial significance of this drug in the pharmaceutical market[2].

Market Segmentation

Dosage Forms

The market for candesartan cilexetil is segmented based on dosage forms, including 4mg, 8mg, 16mg, and 32mg tablets. Each dosage form caters to different patient needs and treatment protocols, contributing to the overall market growth[4].

Challenges and Opportunities

Patent Expirations and Generic Competition

The expiration of patents for candesartan cilexetil has led to the entry of generic competitors, which can impact the market share of branded versions. However, this also presents opportunities for companies to focus on other markets or develop new formulations to maintain market presence[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. Changes in regulations or approval processes can affect the market trajectory of candesartan cilexetil. Companies must navigate these regulatory landscapes to ensure continued market access and growth[1].

Key Takeaways

• The global candesartan cilexetil market is projected to grow from USD 584.2 million in 2024 to USD 800.4 million by 2031.
• North America, Europe, and Asia Pacific are the key regions driving market growth.
• Increasing incidence of hypertension, advancements in drug delivery, and rising awareness about cardiovascular health are significant growth drivers.
• The competitive landscape is marked by strategic partnerships and divestitures to optimize market presence.
• Clinical efficacy, as demonstrated in studies like the CANDLE trial, supports the market position of candesartan cilexetil.

FAQs

What is the current global market size for candesartan cilexetil?

The global candesartan cilexetil market size is estimated to be USD 584.2 million in 2024[1].

Which region holds the largest share of the global candesartan cilexetil market?

North America holds the largest share, with a market size of USD 233.68 million in 2024[1].

What is the projected CAGR for the global candesartan cilexetil market from 2024 to 2031?

The global candesartan cilexetil market is expected to grow at a CAGR of 4.60% from 2024 to 2031[1].

What are the main drivers of the candesartan cilexetil market growth?

The main drivers include the increasing incidence of hypertension, advancements in drug delivery, and rising awareness about cardiovascular health[1].

How does candesartan cilexetil compare to other antihypertensive medications like losartan?

Candesartan cilexetil has been shown to be more effective in reducing blood pressure compared to losartan in clinical trials like the CANDLE study[5].

Sources

1. Cognitive Market Research: "Global Candesartan Cilexetil Market Report 2024"
2. AstraZeneca: "Atacand to be divested to Cheplapharm in Europe"
3. Cognitive Market Research: "Candesartan Cilexetil Drug Market Report 2024 (Global Edition)"
4. Market Research Intellect: "Global Candesartan Cilexetil Tablets Market Size, Scope And Forecast"
5. American College of Cardiology: "Candesartan Versus Losartan Efficacy Comparison Study Group - CANDLE"