Azilsartan kamedoxomil - Generic Drug Details

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

Azilsartan kamedoxomil is the generic ingredient in three branded drugs marketed by Lupin Ltd and Azurity, and is included in three 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:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	798
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		RX	Yes	No	9,169,238		Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	7,157,584			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	7,572,920		Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No	7,157,584			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	7,572,920		Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes	9,066,936		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	200796-001	Feb 25, 2011	5,583,141
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,736,555
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	5,583,141
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	5,736,555
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	5,958,961

International Patents for azilsartan kamedoxomil

Country	Patent Number	Title	Estimated Expiration
Croatia	P20070510
Croatia	P20120667
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.
Denmark	2119715
Hong Kong	1115118	BENZIMIDAZOLE DERIVATIVE AND ITS USE AS AII RECEPTOR ANTAGONIST
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	436	Finland
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	121 5004-2012	Slovakia		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641	C20120004 00052	Estonia		PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
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	12C0034	France		PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207

Azilsartan kamedoxomil Market Analysis and Financial Projection Experimental

Azilsartan Medoxomil: Market Dynamics and Financial Trajectory

Introduction

Azilsartan medoxomil, an angiotensin II receptor blocker (ARB), has been a significant player in the antihypertensive drug market since its FDA approval in 2011. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth drivers, and future projections.

Market Size and Growth

The global azilsartan medoxomil API market has been experiencing robust growth. As of 2024, the market size was estimated at USD 16.6 million and is projected to expand at a compound annual growth rate (CAGR) of 20.60% from 2024 to 2031[1].

Historical Context

In 2021, the global azilsartan medoxomil API market was valued at USD 120 million and is expected to grow at a CAGR of 6.2% from 2021 to 2033[3].

Projected Growth

By 2032, the market is projected to reach USD 188.43 million, growing at a CAGR of 26.49% during the forecast period (2024-2032)[4].

Regional Market Analysis

North America

North America holds a significant market share, with the U.S. being a key driver due to the high demand for antihypertensive drugs and a robust healthcare infrastructure. The region accounted for around 40% of the global revenue, with a market size of USD 6.64 million in 2024, and is expected to grow at a CAGR of 18.8% from 2024 to 2031[1].

Europe

Europe constitutes about 30% of the global revenue, with a market size of USD 4.98 million in 2024. The region is expected to grow at a CAGR of 19.1% from 2024 to 2031, driven by growing public health awareness initiatives and expanding healthcare infrastructure[1].

Asia Pacific

The Asia Pacific region is poised for the highest growth, with a market size of USD 3.82 million in 2024 and a projected CAGR of 22.6% from 2024 to 2031. This growth is driven by rapid urbanization, changing lifestyles, and increasing healthcare expenditure[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa regions, though smaller, are also experiencing growth. Latin America held around 5% of the global revenue with a market size of USD 0.83 million in 2024, expected to grow at a CAGR of 20.0% from 2024 to 2031. The Middle East & Africa region held around 2% of the global revenue with a market size of USD 0.33 million in 2024, expected to grow at a CAGR of 20.3% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Prevalence of Hypertension

The rising prevalence of hypertension, particularly among the aging population, is a significant driver of the market. Hypertension is a major risk factor for cardiovascular diseases, and the demand for effective antihypertensive medications is increasing accordingly[3].

Healthcare Expenditure and Infrastructure

Increasing healthcare expenditure and robust pharmaceutical research and development activities contribute to market growth. Additionally, favorable reimbursement policies and government healthcare programs enhance the accessibility and affordability of medications[1].

Strategic Partnerships

Strategic partnerships between pharmaceutical companies and healthcare providers, as well as collaborations with government health agencies, enhance product availability and distribution channels, further driving market growth[1].

Generic Drug Market

The patent for azilsartan medoxomil expired in 2018, leading to a dominance by generic drug manufacturers. This has made the drug more accessible and affordable, contributing to market expansion[3].

Financial Trajectory

Revenue Projections

The global azilsartan medoxomil API market is expected to reach USD 188.43 million by 2032, growing at a CAGR of 26.49% from 2024 to 2032. This significant growth is driven by the increasing demand for advanced antihypertensive drugs and the expanding healthcare access in various regions[4].

Segment-wise Growth

The 40mg segment is expected to drive sales growth, particularly in North America, due to its optimal balance of efficacy and dosage convenience. In Europe, the hospital segment is anticipated to dominate, while in the Asia Pacific, the drug store segment is expected to lead sales growth[1].

Challenges and Restraints

High Cost of Drug Development

Despite the growth, the market faces challenges such as the high cost of drug development and the stringent regulatory requirements for API manufacturing. These factors may restrain market growth to some extent[3].

Supply Chain Disruptions

The COVID-19 pandemic has disrupted the global supply chain of APIs, leading to shortages and price volatility in some regions. This has had a temporary impact on the market but is expected to stabilize as supply chains recover[3].

Clinical Efficacy and Safety

Pharmacologic Profile

Azilsartan medoxomil has a unique pharmacologic profile compared to other ARBs, with slowed angiotensin II type 1 receptor dissociation rates and improved receptor specificity. It has been shown to reduce blood pressure more effectively than other ARBs like valsartan and olmesartan, with similar safety and tolerability profiles[2].

Clinical Outcomes

Studies have demonstrated that azilsartan medoxomil significantly improves both systolic and diastolic blood pressure from baseline compared to placebo. It also shows added blood pressure lowering when combined with chlorthalidone[2].

Conclusion

Azilsartan medoxomil is poised for significant growth in the antihypertensive drug market, driven by increasing demand, expanding healthcare infrastructure, and strategic partnerships. Despite challenges such as high development costs and supply chain disruptions, the market is expected to expand substantially over the next decade.

Key Takeaways

• The global azilsartan medoxomil API market is projected to grow at a CAGR of 26.49% from 2024 to 2032.
• North America, Europe, and the Asia Pacific are key regions driving market growth.
• Increasing prevalence of hypertension and growing healthcare expenditure are major drivers.
• Generic drug manufacturers dominate the market due to the expired patent.
• The 40mg segment and hospital segment are expected to drive sales in different regions.

FAQs

Q: What is the current market size of the azilsartan medoxomil API market?

A: As of 2024, the global azilsartan medoxomil API market size was estimated at USD 16.6 million[1].

Q: What is the projected CAGR for the azilsartan medoxomil API market from 2024 to 2032?

A: The market is projected to grow at a CAGR of 26.49% from 2024 to 2032[4].

Q: Which regions are expected to drive the growth of the azilsartan medoxomil API market?

A: North America, Europe, and the Asia Pacific are expected to be key drivers of market growth[1][4].

Q: What are the main drivers of the azilsartan medoxomil API market growth?

A: The increasing prevalence of hypertension, growing healthcare expenditure, and strategic partnerships between pharmaceutical companies and healthcare providers are main drivers[1][3].

Q: What challenges might the azilsartan medoxomil API market face?

A: High costs of drug development, stringent regulatory requirements, and supply chain disruptions are potential challenges[3].

Sources

1. Cognitive Market Research - Azilsartan Medoxomil API Market Report 2024 (Global Edition)
2. PubMed - Azilsartan medoxomil: a new angiotensin II receptor antagonist for the treatment of hypertension
3. Data Horizon Research - Azilsartan Medoxomil API Market Size, Share & Forecast 2033
4. Global Growth Insights - Azilsartan Medoxomil API Market Size, Growth | CAGR of 26.49 %
5. DrugBank - Azilsartan medoxomil: Uses, Interactions, Mechanism of Action