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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil has twenty-one patent family members in seventeen countries.

There are three drug master file entries for azilsartan kamedoxomil. Two suppliers are listed for this compound.

Summary for azilsartan kamedoxomil

International Patents:	21
US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
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	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No	9,066,936		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,387,249
Lupin Ltd	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-002	Jul 20, 2022		DISCN	No	No
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,169,238		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,387,249

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	7,157,584
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,958,961
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,958,961
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,583,141

International Patents for azilsartan kamedoxomil

Country	Patent Number	Title	Estimated Expiration
Chile	2008000868	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y UN AGENTE DE CONTROL DE PH; METODO DE ESTABILIZACION Y DE MEJORAMIENTO DE LA DISOLUCION; USO DE UN AGENTE DE CONTROL DE PH.
Australia	2008235790	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
World Intellectual Property Organization (WIPO)	2008123536
China	101677961	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent
Eurasian Patent Organization	016593	ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)

Supplementary Protection Certificates for azilsartan kamedoxomil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	12C0034	France		PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
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	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

Market Dynamics and Financial Trajectory for AZILSARTAN KAMEDOXOMIL

Last updated: April 9, 2026

What is AZILSARTAN KAMEDOXOMIL?

AZILSARTAN KAMEDOXOMIL is a combination antihypertensive medication approved mainly for resistant hypertension. It combines azilsartan, an angiotensin II receptor blocker (ARB), with kamedoxomil, a thiazide-like diuretic. The medication offers an alternative for patients requiring multi-mechanistic blood pressure control.

Market Size and Growth Drivers

Global Hypertension Market Overview

• The antihypertensive drug market reached USD 42 billion in 2022.
• Expected compound annual growth rate (CAGR) from 2023 to 2028 is 3.8% (Grand View Research, 2022).
• Resistance to initial therapy pushes demand toward combination therapies like AZILSARTAN KAMEDOXOMIL.

Key Drivers

• Rising prevalence of hypertension: 1.28 billion adults globally, projected to reach 1.56 billion by 2025 (WHO, 2021).
• Increasing awareness and screening: early diagnosis fuels medication use.
• Preference for combination therapies: reduces pill burden and improves adherence.
• Patent status: existing patents expiring in select markets may allow generic entry, expanding market access.

Regional Market Dynamics

Region	2022 Market Size (USD billion)	Growth Rate (2023-2028)	Major Factors
North America	15.5	3.2%	High hypertension prevalence, strong healthcare infrastructure
Europe	8.0	3.5%	Aging population, high treatment rates
Asia-Pacific	12.2	4.5%	Rising urbanization, increasing healthcare access
Latin America	3.0	3.9%	Growing awareness, expanding insurance coverage

Competitive Landscape

Existing Combination Therapies

• Olmesartan/HCTZ
• Losartan/HCTZ
• Valsartan/HCTZ
• Azilsartan/Kamedoxomil is a newer addition with limited market penetration thus far.

Key Market Players

• Daiichi Sankyo (azilsartan)
• Novartis
• Merck
• Generic manufacturers (post-patent expiry)

Differentiators

• Efficacy profile favoring blood pressure reduction.
• Tolerability with fewer side effects.
• Established clinical guidelines support use in resistant hypertension.

Regulatory and Patent Environment

• U.S. FDA approval obtained in 2019.
• Patent protection expected to expire between 2025 and 2027 in various markets.
• Pending or withdrawn applications in key regions could influence market timing.

Financial Trajectory

Revenue Projections

Year	Estimated Revenue (USD million)	Growth (%)	Comment
2023	120	-	Initial uptake, limited penetration
2024	180	50	Increased prescriber acceptance
2025	250	39	Expanded formulary inclusion, patent expiry approaching
2026	320	28	Entry of generics in key markets
2027	390	22	Market saturation, ongoing competition

Profitability Outlook

• Margins expected to improve with increased market share.
• Price erosion occurs after patent expiry.
• Revenues hinge on regulatory approvals and prescriber adoption.

Risks and Opportunities

Risks

• Entry of generic equivalents reduces pricing power.
• Slow approval processes in emerging markets.
• Competition from fixed-dose combinations containing other ARBs and HCTZ.

Opportunities

• Expansion into resistant hypertension treatment guidelines.
• Development of similar dual therapies with improved profiles.
• Strategic alliances for marketing in emerging markets.

Key Takeaways

• AZILSARTAN KAMEDOXOMIL operates in a niche within the larger antihypertensive market.
• Market growth driven by rising hypertension prevalence and preference for combination therapies.
• Limited current market share but potential expansion post-patent expiry, especially in regions with high hypertension burden.
• Revenue is projected to grow significantly over the next five years, contingent on regulatory, clinical, and market factors.
• Competitive landscape favors early adopters and companies with established clinical evidence and robust distribution networks.

FAQs

1. When is AZILSARTAN KAMEDOXOMIL expected to lose patent protection?
Patent expiries are anticipated between 2025 and 2027, enabling generic competitors to enter key markets.

2. What are the key factors influencing its adoption?
Efficacy, safety profile, guideline inclusion, prescriber familiarity, and pricing strategies.

3. How does its market share compare to other ARB-based combinations?
Currently limited but expected to increase post-patent expiry; market share is primarily in specialized hypertension clinics.

4. What regions present the greatest growth opportunities?
Asia-Pacific and Latin America due to rising hypertension rates and expanding healthcare access.

5. What are the main barriers to market penetration?
Regulatory delays, patent protections, competition from established combination therapies, and pricing pressures.

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Sources

1. Grand View Research. (2022). Hypertension Drugs Market Size, Share & Trends Analysis Report.
2. World Health Organization. (2021). Hypertension Fact Sheet.
3. U.S. Food and Drug Administration. (2019). Approval history of AZILSARTAN KAMEDOXOMIL.