EDARBYCLOR Drug Patent Profile

When do Edarbyclor patents expire, and when can generic versions of Edarbyclor launch?

Edarbyclor is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in forty-four countries.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.

DrugPatentWatch^® Generic Entry Outlook for Edarbyclor

Edarbyclor was eligible for patent challenges on February 25, 2015.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EDARBYCLOR

International Patents:	117
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	34
Drug Prices:	Drug price information for EDARBYCLOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBYCLOR
What excipients (inactive ingredients) are in EDARBYCLOR?	EDARBYCLOR excipients list
DailyMed Link:	EDARBYCLOR at DailyMed

See drug prices for EDARBYCLOR

Recent Clinical Trials for EDARBYCLOR

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

Sponsor	Phase
Takeda	Phase 3

See all EDARBYCLOR clinical trials

Pharmacology for EDARBYCLOR

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 EDARBYCLOR

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 EDARBYCLOR

EDARBYCLOR is protected by five US patents.

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	202331-001	Dec 20, 2011	AB	RX	Yes	No	7,572,920		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,169,238		Y

Expired US Patents for EDARBYCLOR

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

International Patents for EDARBYCLOR

When does loss-of-exclusivity occur for EDARBYCLOR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Mexico

Morocco

New Zealand

Peru

Portugal

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EDARBYCLOR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009277455
Denmark	0520423
Peru	20090550	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH

Supplementary Protection Certificates for EDARBYCLOR

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

Market Dynamics and Financial Trajectory for EDARBYCLOR: Navigating Growth in the Hypertension and Heart Failure Markets

Last updated: July 28, 2025

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Introduction

EDARBYCLOR, a combination antihypertensive medication, has established a significant position in the management of hypertension and, to some extent, heart failure. Combining edarbycin (a diuretic) with olmesartan (an angiotensin receptor blocker), EDARBYCLOR targets a broad spectrum of hypertensive pathophysiology. Its market trajectory is shaped by evolving dynamics in cardiovascular therapeutics, regulatory shifts, and competitive forces. This analysis examines these factors and projects future financial prospects influencing stakeholders ranging from pharmaceutical companies to healthcare providers.

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Market Overview and Product Profile

EDARBYCLOR is marketed primarily for treating hypertension, a condition affecting over 1 billion individuals globally, with a significant proportion in developed markets such as the U.S. and Europe. The drug benefits from the adoption of combination therapy to improve compliance and efficacy in resistant hypertension cases. Its inclusion in major treatment guidelines amplifies its relevance, contributing to expanding its market footprint.

The pharmacological profile of EDARBYCLOR, with demonstrated efficacy in reducing blood pressure with a tolerable safety profile, aligns well with current clinical practice emphasis on combination therapies—expected to grow due to the increasing prevalence of hypertension and lifestyle-related cardiac risk factors.

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Market Drivers

1. Rising Global Hypertension Burden

The World Health Organization estimates that nearly 1.28 billion adults worldwide have hypertension, with prevalence climbing in low-to-middle-income countries due to urbanization and lifestyle changes [1]. This burgeoning prevalence drives demand for effective antihypertensive therapies, including fixed-dose combinations like EDARBYCLOR.

2. Clinical Guidelines Favoring Combination Therapy

Recent guidelines from the American College of Cardiology (ACC) and the American Heart Association (AHA) endorse initial combination therapy in patients with stage 2 hypertension or high cardiovascular risk [2]. This endorsement fosters increased prescribing of combinations like EDARBYCLOR, positioning it for sustained growth.

3. Improved Patient Compliance and Prescription Adherence

Fixed-dose combinations streamline medication regimens, crucial for chronic disease management. The convenience factor enhances adherence, thereby improving long-term blood pressure control and impacting pharmaceutical sales positively.

4. Expanding Indications and Off-Label Uses

Ongoing research and post-market studies exploring EDARBYCLOR’s efficacy in heart failure and other cardiovascular conditions open avenues for broader indications, potentially stimulating higher utilization.

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Competitive Landscape

The antihypertensive segment, particularly fixed-dose combination therapies, is highly competitive. EDARBYCLOR’s key competitors include other ARB-based combinations, ACE inhibitors, calcium channel blockers, and diuretics.

Major players such as Pfizer (with drugs like Amlodipine/Benazepril), Novartis (Valsartan/HCTZ), and Merck (Treximet for migraine but with cardiovascular portfolio) command significant market shares. Edarbyclor's unique positioning derives from its specific combination of edarbin and olmesartan, offering benefits in tolerability and efficacy, but market dominance requires ongoing differentiation through pharmacovigilance and physician education.

Patent and Regulatory Milestones

The patent landscape critically influences EDARBYCLOR’s market potential. The drug's patent expiry dates and exclusivity periods directly impact revenue streams, with generic entrants eroding market share post-patent expiration. Regulatory approvals in emerging markets can augment revenue streams, especially in Asia and Latin America, where hypertension remains underdiagnosed.

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Financial Trajectory and Revenue Forecasting

1. Historical Sales Performance

Since its FDA approval in 2012, EDARBYCLOR has experienced steady growth in the U.S., driven by heightened awareness and guideline endorsements. In 2021, projected global sales reached approximately $750 million, reflecting increased adoption [3].

2. Market Penetration and Growth Potential

The drug’s market penetration is expected to grow at a compound annual growth rate (CAGR) of around 6-8% over the next five years, fueled by increased prescribing in resistant hypertension and expanding markets in Asia-Pacific.

3. Impact of Patent Expiration and Generics

Predicted patent expiry around 2025 could result in a significant revenue decline unless the innovator company successfully introduces next-generation formulations or new indications. Generic competition typically drives prices down by 40-60%, impacting margins.

4. Emerging Market Opportunities

Countries with rising cardiovascular disease burdens represent fertile ground for expansion. Price-sensitive markets are increasingly adopting generic versions, but premium branding and formulary inclusion can help sustain revenue.

5. R&D and Pipeline Developments

Ongoing clinical trials investigating EDARBYCLOR’s efficacy in heart failure, stroke prevention, and diabetes-related hypertension could fortify its market position. Positive trial outcomes may lead to label expansions, opening new revenue streams.

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Market Challenges and Risks

1. Competitive Pressures

The aggressive proliferation of combination therapies and generics limits pricing power. Market saturation window post-patent expiry demands innovation and strategic marketing.

2. Regulatory Hurdles

Stringent regulatory standards for new indications or formulations could delay market entry or approval, affecting financial forecasts.

3. Changing Prescribing Trends

Physician preferences may shift toward newer agents or monotherapies, especially with the advent of novel drug classes like SGLT2 inhibitors with cardiovascular benefits.

4. Reimbursement and Cost-Containment

Insurers’ push for cost-effective therapies pressures prices and formulary access, impacting revenue potential.

5. Patent Litigation and Intellectual Property Risks

Legal disputes over patent rights can delay market exclusivity and affect revenues.

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Future Outlook and Strategic Recommendations

Market Growth Approximation

Based on current growth rates and impending patent cliffs, EDARBYCLOR’s revenues are projected to decline by approximately 15-25% post-2025 unless new indications or formulations are successfully developed. Strategic investment in R&D, especially exploring combinatorial benefits in heart failure, could offset impending declines.

Innovation and Diversification

Developing extended-release formulations or combination variants with other cardiovascular agents could rejuvenate growth. Emphasizing real-world evidence and guideline endorsements will enhance prescriber confidence.

Market Penetration in Emerging Economies

Formulary inclusion and tiered pricing strategies are critical in expanding market share across Asia and Africa. Local partnerships can facilitate distribution and educate clinicians on the drug’s profile.

Regulatory Strategy

Proactive engagement with regulators in target markets and pursuit of expedited pathways for label expansion will accelerate revenue growth.

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Key Takeaways

• Growing Demand: The global hypertension epidemic underpins sustained demand for EDARBYCLOR, particularly given guideline favorability for combination therapies.
• Patent Lifecycle: The impending patent expiration around 2025 necessitates strategic planning for revenue management, emphasizing innovation and pipeline expansion.
• Competitive Dynamics: Market is crowded with alternative therapies; differentiation and value propositions are vital for maintaining market share.
• Market Expansion: Emerging markets offer substantial growth prospects, provided pricing and reimbursement challenges are addressed.
• Innovation as Growth Driver: Future growth hinges on developing new formulations, expanding indications, and integrating novel clinical evidence.

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FAQs

1. When is EDARBYCLOR’s patent set to expire, and how does this impact future sales?
The patent expiration is anticipated around 2025, which could lead to increased generic competition and a decline in branded drug revenues unless offset by new formulations or indications.

2. What are the primary competitors to EDARBYCLOR in the antihypertensive market?
Major competitors include fixed-dose combinations like Valsartan/HCTZ (Novartis), Amlodipine/Benazepril (Pfizer), and other ARB-based therapies with similar efficacy profiles.

3. How does guideline endorsement influence EDARBYCLOR’s market share?
Guideline endorsements from organizations like ACC/AHA greatly expand prescriber acceptance, driving adoption and reinforcing the drug’s position within first- and second-line therapies.

4. Which emerging markets present the highest growth opportunity for EDARBYCLOR?
Asia-Pacific, Latin America, and the Middle East are key regions, given rising hypertension prevalence, healthcare infrastructure expansion, and increasing urbanization.

5. What strategies can pharmaceutical companies adopt to mitigate the risks associated with patent expiry?
Investing in pipeline innovations, exploring new indications, optimizing formulations, and establishing strong physician and patient engagement strategies can safeguard long-term profitability.

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References

[1] World Health Organization. "Hypertension." WHO Global Database, 2021.
[2] Whelton, P. K., et al. "2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults." J Am Coll Cardiol, 2018.
[3] IQVIA. "Pharmaceutical Market Analysis," 2022.