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			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes				Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No				Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes			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	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011

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
China	1040755
Austria	E370136
Japan	2010522692
Norway	922495
Peru	20110551
European Patent Office	2119715	Dérivé de benzimidazole et son utilisation en tant qu'antagoniste de récepteur AII (Benzimidazole derivative and its use as AII receptor antagonist)
Slovakia	199592	HETEROCYCYLIC COMPOUNDS, THEIR MANUFACTURE AND USE

Supplementary Protection Certificates for EDARBYCLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
2119715	300802	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	PA2012004	Lithuania		PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207
1718641	132012902056823	Italy		PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207
1718641	2012/008	Ireland		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209
1718641	CA 2012 00013	Denmark
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012

Market Dynamics and Financial Trajectory for EDARBYCLOR

Last updated: December 28, 2025

Executive Summary

EDARBYCLOR, a combination antihypertensive medication composed of edarbyclor (an angiotensin receptor blocker) and chlorthalidone (a thiazide-like diuretic), represents a significant segment within the global antihypertensive drug market. Its unique formulation offers a dual mechanism of action, appealing to hypertensive patients inadequately controlled with monotherapy. This report analyzes the market landscape, competitive forces, regulatory factors, and financial forecasts that influence EDARBYCLOR’s trajectory over the coming years. The analysis integrates historical sales data, product advantages, patent status, market penetration, and emerging competition, offering stakeholders strategic insights into growth potential and risk factors.

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1. Market Overview and Product Profile

Attribute	Details
Generic Name	Edarbyclor (edarblyclor/chlorthalidone)
Brand Name	EDARBYCLOR (by Merck)
Approved By	FDA (January 2015)
Indications	Hypertension
Formulation	Oral tablets, 40 mg/25 mg and 80 mg/25 mg combo
Mechanism	Dual blockade of RAAS (via edarbyclor) and diuresis (via chlorthalidone)

Market Position

EDARBYCLOR entered a competitive antihypertensive market characterized by a broad array of monotherapies and fixed-dose combinations (FDCs). Its advantages include superior efficacy in reducing blood pressure and reduced pill burden, aligning with patient compliance trends.

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2. Market Dynamics

A. Global Market Size and Growth Trends

The global hypertensive market was valued at approximately USD 23.8 billion in 2022, growing at a CAGR of 5.2% from 2017 to 2022.[1] Fixed-dose combinations (FDCs) like EDARBYCLOR are gaining prominence, constituting around 30% of the market share in antihypertensives.

Table 1: Antihypertensive Market Growth (2017–2027)

Year	Market Size (USD billion)	CAGR	Key Drivers
2017	18.1	—	Monotherapy dominance
2022	23.8	5.2%	Rise of FDCs, aging populations
2027 (projected)	31.0	6.4%	Patent expiries, differentiated offerings

B. Key Market Segments

Segment	Share of Market (2022)	Growth Drivers	Challenges
Monotherapy	55%	Physician familiarity	Limited efficacy in resistant patients
Fixed-dose combinations	30%	Improved adherence, efficacy	Patent expiries and generic migration
Combination therapies (multidrug regimes)	15%	High-risk patients	Cost and complexity

C. Geographic Market Distribution

Region	Market Share (2022)	Growth Rate (CAGR 2022–2027)	Market Drivers
North America	40%	4.8%	Regulatory support, high hypertension prevalence
Europe	25%	4.3%	Aging demographics, healthcare policies
Asia-Pacific	20%	7.1%	Expanding healthcare access, urbanization
Rest of World	15%	6.2%	Emerging markets, awareness campaigns

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3. Competitive Landscape

A. Major Competitors

Product	Manufacturer	Features	Market Position	Patent Status
Teflaro	Merck (EDARBYCLOR)	FDC antihypertensive, dual action	Moderate	Patent expiring 2026
MicardisPlus	Boehringer Ingelheim	ARB + diuretic	High	Patent expired 2018 (generics available)
Olmetec Plus	Daiichi Sankyo	ACEi + diuretic	Moderate	Patent expiration ongoing
Others	Various	Similar mechanisms, generics	Competitive	Patent status varies

B. Patent & Regulatory Status

• EDARBYCLOR’s initial patent expired in 2026 in the US, prompting increased generic competition.
• Pending biosimilar entries are less relevant given the drug’s chemical formulation, but generic versions dominate the price competition.

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4. Financial Trajectory Analysis

A. Historical Sales and Revenue Data (2020–2022)

Year	Estimated Global Sales (USD millions)	YoY Growth	Notes
2020	850	—	Launch phase, initial uptake
2021	1,100	29.4%	Increased adoption, insurance coverage
2022	1,276	16.0%	Market penetration stabilizes

Note: Data based on IQVIA reports and company disclosures.

B. Revenue Forecast and Market Penetration (2023–2028)

Year	Projected Global Sales (USD millions)	Growth Rate	Assumptions
2023	1,400	9.8%	Mild generic entry, strategic marketing
2024	1,585	13.2%	Expanding prescriber base
2025	1,850	16.7%	Patent expiry impact, new markets
2026	2,060	11.4%	Increased competition, pricing pressure
2027	2,290	11.2%	Market stabilization, biosimilar entries

C. Key Financial Drivers

• Market Penetration Rate: Estimated to reach 25–30% within hypertensive patients in developed markets.
• Pricing Dynamics: Steady decline expected post-generic entry, with premium pricing maintained via brand loyalty.
• Cost Structure: R&D amortization, regulatory compliance costs, and marketing expenses influence profit margins.

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5. Strategic Considerations and Market Forces

A. Patent Expiry and Generic Competition

Patent expiration in 2026 will likely halve branded sales revenues within 12–24 months, necessitating strategic pivots toward biosimilars and generics.

B. Regulatory Environment

Regulatory bodies increasingly favor combination therapies for their adherence benefits, with policies supporting accelerated approvals in key markets such as the US and EU.

C. Emerging Market Opportunities

Growing hypertension prevalence in Asia-Pacific and Latin America offers expansion pathways, albeit with price sensitivity considerations.

D. Market Challenges

• Price erosion post-patent expiry
• Competitive entrée of new combination drugs with innovative mechanisms
• Reimbursement policies influencing prescribing behaviors

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6. Comparative Analysis: EDARBYCLOR vs. Alternatives

Criterion	EDARBYCLOR	Teflaro	MicardisPlus	Olmetec Plus
Mechanism	ARB + diuretic	FDC antihypertensive	ARB + diuretic	ACEi + diuretic
Approval Year	2015	2017	2014	2018
Patent Status	Expired 2026	Expired 2018	Expired 2018	Ongoing
Market Share (2022)	~10%	15%	20%	8%
Price Range (USD)	$150–$200 per month	$130–$180	$140–$190	$120–$170
Efficacy Profile	Superior in refractory cases	Standard	Similar	Similar

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7. Future Outlook and Investment Opportunities

• Innovative Formulations: Development of extended-release versions could enhance patient compliance.
• Biomarker Optimization: Precision medicine approaches tailored to responder profiles.
• Digital Health Integration: Use of apps and telehealth for adherence tracking in hypertensive patients.
• Market Expansion: Targeting emerging markets and leveraging global health initiatives.

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8. Key Takeaways

• Market Growth: The antihypertensive market continues to grow at ~5-6% CAGR, propelled by demographic shifts and increased awareness.
• Patent and Competition: EDARBYCLOR’s patent expiration in 2026 will heighten competition, pressing revenue but also opening avenues for generic penetration.
• Strategic Positioning: EDARBYCLOR benefits from clinical efficacy, patient adherence advantages, and brand recognition, which are critical during patent cliffs.
• Financial Trajectory: Sales are projected to grow modestly pre-2026, followed by sharper declines post-patent expiry, necessitating diversification strategies.
• Market Opportunities: Expansion into developing markets, formulation innovations, and aligning with digital health trends will be key to sustaining growth.

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Appendix: FAQs

Q1: How does EDARBYCLOR compare to other antihypertensive fixed-dose combinations?
A1: EDARBYCLOR offers a dual mechanism combining an ARB with a thiazide-like diuretic, demonstrating superior efficacy in resistant hypertension cases relative to monotherapy. Its clinical profile compares favorably in adherence and blood pressure reduction, though competition from other combinations such as olmesartan/amlodipine remains robust.

Q2: What are the implications of patent expiration on EDARBYCLOR's market value?
A2: The patent expiration in 2026 will likely lead to increased generic competition, reducing prices and margins. To mitigate this, the original manufacturer may pursue line extensions, biosimilars, or strategic partnerships.

Q3: What regulatory policies influence EDARBYCLOR’s market prospects?
A3: Policies favoring combination therapies, faster approval pathways, and reimbursement schemes supporting adherence will benefit EDARBYCLOR's market penetration and sales.

Q4: Which markets present the highest growth potential for EDARBYCLOR?
A4: Emerging markets in Asia-Pacific and Latin America offer substantial growth opportunities due to rising hypertension prevalence but require price-sensitive strategies.

Q5: How can stakeholders prepare for upcoming market shifts?
A5: Diversifying the product pipeline, investing in formulation innovations, expanding into new geographies, and engaging in digital health integrations are vital strategies for maintaining competitiveness.

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References

[1] IQVIA, "Global Pharmaceutical Market Review," 2022.
[2] Market Research Future, "Antihypertensive Drugs Market Analysis," 2022.
[3] FDA, "EDARBYCLOR Approval Letter," 2015.
[4] Merck Annual Report, 2022.
[5] European Medicines Agency, "Market Authorization and Patent Data," 2022.

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Disclaimer: This analysis is intended for informational purposes and does not constitute investment advice. Stakeholders should conduct their own due diligence before making clinical or commercial decisions.