Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details

What are the generic drug sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of patent protection?

Azilsartan kamedoxomil; chlorthalidone is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd and Azurity, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil; chlorthalidone has one hundred and seventeen patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for azilsartan kamedoxomil; chlorthalidone

International Patents:	117
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azilsartan kamedoxomil; chlorthalidone
DailyMed Link:	azilsartan kamedoxomil; chlorthalidone at DailyMed

Pharmacology for azilsartan kamedoxomil; chlorthalidone

Drug Class	Angiotensin 2 Receptor Blocker Thiazide-like Diuretic
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure Increased Diuresis

Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDARBYCLOR	Tablets	azilsartan kamedoxomil; chlorthalidone	40 mg/12.5 mg and 40 mg/25 mg	202331	1	2022-04-19

US Patents and Regulatory Information for azilsartan kamedoxomil; chlorthalidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,066,936		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	7,572,920		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	7,572,920		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,066,936		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	7,157,584			Y

Expired US Patents for azilsartan kamedoxomil; chlorthalidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,583,141
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	5,583,141
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,157,584
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,572,920
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	7,572,920
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	7,157,584

International Patents for azilsartan kamedoxomil; chlorthalidone

Country	Patent Number	Title	Estimated Expiration
Taiwan	200902089	Solid pharmaceutical composition
Colombia	6341633
South Africa	201100871
Portugal	1718641
China	101381366	Benzimidazole derivative and its use as a ii receptor antagonist
Eurasian Patent Organization	200970896	ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ

Supplementary Protection Certificates for azilsartan kamedoxomil; chlorthalidone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	436	Finland
1718641	C 2012 017	Romania		PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
2119715	2018/006	Ireland		PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1718641	CA 2012 00013	Denmark
1718641	91962	Luxembourg		91962, EXPIRES: 20261207

Market Dynamics and Financial Trajectory for Azilsartan Kamedoxomil; Chlorthalidone

Last updated: July 30, 2025

Introduction

The pharmaceutical landscape for antihypertensive medications is dynamic, driven by evolving clinical guidelines, patent expirations, and emerging competitors. Among notable drugs within this segment are azilsartan kamedoxomil—an angiotensin receptor blocker (ARB)—and chlorthalidone, a thiazide-like diuretic. These medications serve critical roles in managing hypertension and preventing cardiovascular events. This report evaluates their current market positioning, projected growth trajectories, and the factors influencing their financial performance over the coming years.

Market Overview

Azilsartan Kamedoxomil: A Competitive ARB

Introduced in the mid-2010s, azilsartan kamedoxomil is marketed primarily under the brand name Edarbi. It competes in a mature segment, with key players including losartan, valsartan, and olmesartan. Its positioning as a potent ARB with once-daily dosing offers advantages, particularly in resistant hypertension cases.

Market penetration remains limited owing to the entrenched presence of established ARBs. Nonetheless, its favorable efficacy and tolerability profiles enable niche expansion, especially among patients intolerant to other ARBs.

Chlorthalidone: A Mainstay Diuretic with Growing Recognition

Chlorthalidone has experienced a resurgence, fueled by evidence (e.g., the SPRINT trial) demonstrating superior cardiovascular outcomes compared to hydrochlorothiazide. Its longer half-life and sustained blood pressure control make it a preferred diuretic in antihypertensive regimens. Despite being off-patent, its utilization is increasing, driven by updated guidelines favoring chlorthalidone over other diuretics.

Market Drivers

Clinical Evidence and Guidelines

• Azilsartan Kamedoxomil: Its clinical profile supports use in resistant hypertension. The 2021 ESC/ESH guidelines recognize ARBs broadly but do not specify azilsartan owing to limited head-to-head trials. Nevertheless, ongoing comparative studies and real-world data could validate its market niche.

• Chlorthalidone: The compelling evidence from multiple large-scale trials elevates its status, prompting guidelines to recommend it as a first-line agent, especially in high-risk populations. This evolving preference shifts the market toward its increased adoption.

Patent Status and Generic Entry

• Azilsartan kamedoxomil: Patents expired or are set to expire in the next 3–5 years in major markets, paving the way for generic competition, which could significantly reduce pricing and affect profitability.

• Chlorthalidone: Its status as a generic medication means minimal patent constraints, enabling widespread access and low-cost formulations, contributing to steady market demand.

Regulatory and Reimbursement Dynamics

• Pricing and reimbursement policies influence drug accessibility. Cost-effectiveness analyses position chlorthalidone favorably, encouraging formulary inclusion, while azilsartan’s higher price point may limit use to specific patient subsets.

Financial Trajectory

Azilsartan Kamedoxomil

• Current Revenue: Estimated global sales are modest, roughly in the range of USD 100-200 million annually, with North American and European markets being primary revenue sources.

• Growth Prospects: Limited by competitive pressures, patent expiry, and the absence of data supporting superior efficacy over existing ARBs. However, niche markets, such as resistant hypertension, provide potential upside. Incremental growth is anticipated at approximately 2–4% annually over the next 5 years, contingent upon successful commercialization strategies and uptake in emerging markets.

• Challenges: Elevated pricing compared to generic ARBs, slow adoption due to brand familiarity, and potential generic competition eroding profit margins.

Chlorthalidone

• Current Revenue: As a generic, global sales surpass USD 1 billion annually, mainly driven by formulary preferences and clinical evidence.

• Growth Trajectory: Increased recognition due to evidence-based guidelines is growing demand, particularly in the US and Europe. Demand is projected to increase at 4–6% annually over the next five years, with this growth influenced by the expanding evaluation of chlorthalidone in cardiovascular outcomes.

• Market Risks: Minimal, given its patent expiry and high generic penetration. Supply chain stability and manufacturing capacity will be crucial for consistent market presence.

Market Challenges and Opportunities

Challenges

• Market Saturation: Both drugs face saturated markets with entrenched generic competition, especially chlorthalidone.

• Pricing Pressures: Payer policies favor low-cost generics, limiting revenue growth opportunities for branded formulations.

• Clinical Data Limitations: For azilsartan, the absence of compelling comparative trials hampers differentiation efforts.

Opportunities

• Niche and Resistant Hypertension Indications: Azilsartan could capture segments of resistant hypertension if its clinical advantages are substantiated through further trials.

• Guideline-Driven Adoption: Chlorthalidone’s inclusion in elevated guidelines enhances its favorable outlook.

• Emerging Markets: Increasing access and healthcare infrastructure expansion could expand the patient base.

Competitive Landscape

The market primarily includes:

• ARBs: Losartan, valsartan, olmesartan, and newer entrants like azilsartan.

• Diuretics: Hydrochlorothiazide, chlorthalidone, indapamide.

Established pharmaceutical giants dominate, with generics eroding margins in many instances. Strategic differentiation relies on demonstrating clinical benefits, cost-effectiveness, and market access.

Regulatory and Patent Outlook

• Azilsartan: Patent expiry within 3–5 years in major markets, opening opportunities for generics and biosimilars.

• Chlorthalidone: No patent restrictions; predictable supply chain and manufacturing are essential for market stability.

Strategic Recommendations

• For Azilsartan Kamedoxomil: Focus on niche markets, gather real-world evidence to demonstrate superiority or benefits over competitors, and consider strategic partnerships to expand market access.

• For Chlorthalidone: Leverage its strong evidence base, maintain competitive pricing, and ensure manufacturing excellence to consolidate market share.

Key Takeaways

• The market for azilsartan kamedoxomil faces challenges due to patent expiration and strong competition but retains niche potential in resistant hypertension management. Growth remains modest, contingent upon clinical differentiation and commercialization strategies.

• Chlorthalidone enjoys a robust position driven by supportive clinical data and guideline endorsements, with a consistent upward trajectory fueled by generic penetration and increased adoption in cardiovascular risk reduction.

• Long-term success for both drugs hinges on navigating patent expirations, maintaining supply chain integrity, and aligning with evolving clinical practices and payer policies.

• Emerging markets offer growth avenues, especially if affordability and access are prioritized.

• The competitive landscape emphasizes the importance of evidence-based differentiation and strategic collaborations to optimize revenue potential.

FAQs

1. What is the primary therapeutic advantage of azilsartan kamedoxomil over other ARBs?
   Azilsartan kamedoxomil demonstrates potent angiotensin receptor blockade with once-daily dosing, offering improved blood pressure reduction in resistant hypertension cases. However, comparative clinical trials versus other ARBs remain limited.

2. How does chlorthalidone compare to hydrochlorothiazide in hypertension management?
   Chlorthalidone offers a longer half-life and higher potency, leading to more sustained blood pressure control and better cardiovascular outcomes, as supported by randomized trials like SPRINT.

3. What factors could influence the future sales of azilsartan kamedoxomil?
   Patent expiration, clinical trial results demonstrating clear benefits, healthcare provider adoption, and cost-effectiveness will impact sales trajectory.

4. What market trends could benefit chlorthalidone over other diuretics?
   Increasing guideline endorsements, growing recognition of its superior outcomes, and expanding use in high-risk populations could elevate chlorthalidone’s market share.

5. Are there any significant regulatory hurdles for these drugs?
   Patent expiration for azilsartan may lead to generic entry and increased competition, while regulatory pathways for generics are straightforward. Chlorthalidone, being generic, faces minimal hurdles but must maintain manufacturing standards.

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References

[1] European Society of Cardiology. ESC/ESH hypertension guidelines, 2021.
[2] SPRINT Trial Publication. New England Journal of Medicine, 2015.
[3] IMS Health Data. Global antihypertensive drug sales, 2022.
[4] U.S. Food and Drug Administration. Azilsartan approval filings, 2014.
[5] IQVIA Institute. The Impact of Generics on Market Dynamics, 2021.