AZILSARTAN KAMEDOXOMIL - Generic Drug Details

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

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

Azilsartan kamedoxomil has eighty-nine patent family members in thirty-six countries.

There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL

International Patents:	89
US Patents:	5
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL
What excipients (inactive ingredients) are in AZILSARTAN KAMEDOXOMIL?	AZILSARTAN KAMEDOXOMIL excipients list
DailyMed Link:	AZILSARTAN KAMEDOXOMIL at DailyMed

Pharmacology for AZILSARTAN KAMEDOXOMIL

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDARBI	Tablets	azilsartan kamedoxomil	40 mg and 80 mg	200796	1	2020-04-10

US Patents and Regulatory Information for AZILSARTAN KAMEDOXOMIL

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	202331-001	Dec 20, 2011	AB	RX	Yes	No			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes				Y
Lupin Ltd	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-001	Jul 20, 2022		DISCN	No	No
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes				Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes			Y

Expired US Patents for AZILSARTAN KAMEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011

International Patents for AZILSARTAN KAMEDOXOMIL

Country	Patent Number	Title	Estimated Expiration
Norway	332344
Norway	20064251
Montenegro	01643	DERIVATI BENZIMIDAZOLA I NJIHOVO KORIŠĆENJE KAO ANTAGONISTA RECEPTORA A II (BENZIMIDAZOLE DERIVATIVE AND USE AS AII RECEPTOR ANTAGONIST)
Peru	20090550	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH
Serbia	50537	DERIVATI BENZIMIDAZOLA I NJIHOVO KORIŠĆENJE KAO ANTAGONISTA RECEPTORA A II (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS A II RECEPTOR ANTAGONIST)
Germany	602005002030
Brazil	PI0507984	composto ou um sal do mesmo, processo para produzir um composto, medicamento, métodos para antagonizar angiotensina ii em um mamìfero, para melhorar a resistência de insulina em um mamìfero e para prevenir ou tratar doenças circulatórias em um mamìfero, e, uso do composto

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2119715	300802	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	1290016-3	Sweden		PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641	C300525	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
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	2012C/025	Belgium		PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209

Market Dynamics and Financial Trajectory for AZILSARTAN KAMEDOXOMIL

Last updated: July 29, 2025

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Introduction

AZILSARTAN KAMEDOXOMIL represents a novel antihypertensive combination drug, integrating azilsartan medoxomil—a potent angiotensin II receptor blocker (ARB)—with hydrochlorothiazide, a widely used diuretic. Since its regulatory approval, this medication has garnered significant attention for its efficacy in managing hypertension, a leading risk factor for cardiovascular disease globally. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of AZILSARTAN KAMEDOXOMIL offers essential insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers. This analysis explores the current market environment, competitive positioning, regulatory factors, and future growth prospects.

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Market Overview

Global Hypertension Drug Market

The global antihypertensive medications market is projected to reach over $36 billion by 2025, driven by increasing hypertension prevalence, aging populations, and growing awareness of cardiovascular health [1]. ARBs constitute a significant segment owing to their favorable side-effect profile compared to ACE inhibitors and beta-blockers.

Role of Fixed-Dose Combinations (FDCs)

FDCs, such as AZILSARTAN KAMEDOXOMIL, are increasingly favored for their convenience and improved patient adherence. The World Health Organization (WHO) emphasizes the importance of fixed-dose combinations for chronic disease management, leading to a rising demand in both developed and emerging markets [2].

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Market Dynamics Influencing AZILSARTAN KAMEDOXOMIL

1. Competitive Landscape

AZILSARTAN KAMEDOXOMIL operates within a highly competitive environment. Key competitors include other ARB/diuretic combinations like olmesartan medoxomil/hydrochlorothiazide and valsartan/hydrochlorothiazide. Given the multiple approved formulations, the drug’s market share depends heavily on factors such as efficacy, safety, pricing, and insurance coverage.

2. Patent Status and Generic Competition

Since the patent expiration of azilsartan medoxomol in various markets, generic versions have entered the market, intensifying price competition. The original branded formulations maintain premium pricing due to clinical familiarity and manufacturer marketing efforts. The timing of patent cliffs and secondary patents will significantly influence the drug’s market share and revenue potential.

3. Regulatory Approvals and Market Penetration

AZILSARTAN KAMEDOXOMIL’s approval status varies globally. It has gained regulatory approval in key markets such as the U.S. (FDA), EU (EMA), and select emerging markets. Regulatory hurdles or delays can impact the drug's commercial availability, while favorable approval processes can accelerate uptake.

4. Prescriber and Patient Acceptance

Physician preferences favor medications with demonstrated safety profiles and proven efficacy. Payers and healthcare providers are increasingly conscious of cost-effectiveness, influencing prescribing behaviors. The combination's clinical profile supports its adoption, especially among patients requiring multiple antihypertensive agents.

5. Pricing and Reimbursement Policies

Pricing strategies are critical. In markets with national health programs or strict formulary controls, securing reimbursement approvals directly impacts sales. Higher-priced branded drugs face pressure from generics, especially where multiple FDCs exist.

6. Demographic and Epidemiological Trends

The rising prevalence of hypertension—estimated over 1.3 billion globally—fuels demand for effective treatments. Urbanization, lifestyle changes, and aging populations notably increase the need for sustained antihypertensive therapy, supporting a positive financial trajectory.

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Financial Trajectory Analysis

Revenue Potential

Given the large patient base, AZILSARTAN KAMEDOXOMIL’s revenue hinges on market penetration, pricing strategies, and competitive positioning. In mature markets, initial sales are often driven by early adopters, with subsequent expansion in secondary care settings. The drug’s superior clinical profile can command premium pricing, especially in markets emphasizing personalized medicine.

Market Penetration Strategies

Pharmaceutical companies are employing multi-tiered strategies:

• Direct-to-physician marketing emphasizing the drug’s efficacy and safety.
• Patient assistance programs to improve adherence.
• Expansion into emerging markets with growing hypertension burdens.

Forecasted Growth Trends

Analysts project a compound annual growth rate (CAGR) of 4-6% over the next five years for fixed-dose ARB/diuretic combinations, driven by increased hypertension awareness, improved healthcare infrastructure, and early introduction of newer formulations [3].

Cost-Efficiency and Value Proposition

As healthcare systems emphasize value-based care, AZILSARTAN KAMEDOXOMIL may see increased utilization if evidence demonstrates superior control of blood pressure and reduced hospitalization rates for cardiovascular events. Cost-effectiveness analyses favor drugs that improve adherence and reduce long-term complications.

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Regulatory and Patent Landscape Impact

Patent stability remains a critical factor. The expiration of key patents can lead to generic competition, drastically reducing prices. Conversely, securing secondary patents or exclusivity can prolong commercial advantages. Strategic collaborations and licensing agreements may also influence market entry and expansion.

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Impact of Market Trends and Innovation

Emerging trends—such as digital health integration and personalized therapy—may influence the drug’s market course. Pharmaceutical companies are exploring novel delivery mechanisms and biomarker-driven indications. These innovations can create a differentiated market position and bolster financial trajectories.

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Challenges and Risks

• Generic Entry: Erosion of margins post-patent expiration.
• Market Saturation: Limited room for incremental growth once key markets are saturated.
• Pricing Pressure: Increasing emphasis on biosimilars and generics.
• Regulatory Barriers: Stringent approval processes could delay access.
• Clinical Data Requirements: Evolving standards necessitate ongoing investment in supportive evidence.

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Opportunities and Future Outlook

The global shift toward comprehensive hypertension management supports incremental growth. Strategic geographic expansion, focusing on underserved markets with rising hypertension prevalence, offers substantial upside. Additionally, integrating the drug into combination regimens tailored to specific patient subgroups could expand its use.

The anticipated introduction of next-generation ARBs with enhanced efficacy and tolerability, combined with technological innovations in drug delivery, could shift market dynamics. Nonetheless, AZILSARTAN KAMEDOXOMIL’s established clinical profile positions it as a resilient asset within the antihypertensive portfolio.

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Key Takeaways

• Growth Potential: Rooted in the global increase in hypertension prevalence and strategic market expansion.
• Competitive Risks: Patent expiries and generic competition threaten revenue streams; patent strategies are crucial.
• Pricing and Reimbursement: Market success hinges on favorable reimbursement, especially in cost-conscious regions.
• Regulatory Environment: Regulatory approvals dictate geographical reach and timing; staying ahead with robust data is vital.
• Innovation and Differentiation: Continued R&D, personalized medicine, and digital health integration can enhance market share.

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FAQs

1. What differentiates AZILSARTAN KAMEDOXOMIL from other antihypertensive drugs?
Its combination of potent ARB activity and diuretic effects offers superior blood pressure control with a favorable safety profile, improving patient adherence compared to monotherapies.

2. How does patent expiration impact AZILSARTAN KAMEDOXOMIL’s market potential?
Patent expiration allows generics entry, significantly reducing prices and margins but expanding access. Strategic patent management and secondary patents can mitigate early erosion.

3. What markets hold the highest growth prospects for AZILSARTAN KAMEDOXOMIL?
Emerging markets such as India, China, and Latin America, driven by rising hypertension prevalence and expanding healthcare infrastructure, present expanding opportunities.

4. What role do healthcare policies play in the drug’s adoption?
Reimbursement policies, formulary decisions, and national treatment guidelines heavily influence prescribing habits and sales volume.

5. How does the evolving landscape of personalized medicine affect AZILSARTAN KAMEDOXOMIL?
Targeted therapy based on genetic or biomarker profiles may refine patient selection, improving outcomes and market positioning for bespoke hypertension treatments.

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References

[1] Market Research Future, "Hypertension Drugs Market Forecast," 2022.
[2] World Health Organization, "Guidelines for the Management of Hypertension," 2019.
[3] MarketsandMarkets, "Antihypertensive Drugs Market Analysis," 2021.