EDARBI Drug Patent Profile

Which patents cover Edarbi, and what generic alternatives are available?

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

This drug has eighty-nine patent family members in thirty-six countries.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.

DrugPatentWatch^® Generic Entry Outlook for Edarbi

Edarbi 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 EDARBI

International Patents:	89
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	15
Patent Applications:	262
Drug Prices:	Drug price information for EDARBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBI
What excipients (inactive ingredients) are in EDARBI?	EDARBI excipients list
DailyMed Link:	EDARBI at DailyMed

See drug prices for EDARBI

Recent Clinical Trials for EDARBI

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

Sponsor	Phase
Takeda
Takeda	Phase 1
University of Chicago	N/A

See all EDARBI clinical trials

Pharmacology for EDARBI

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 EDARBI

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 EDARBI

EDARBI is protected by three 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	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No				Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes				Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes			Y

Expired US Patents for EDARBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	200796-001	Feb 25, 2011

International Patents for EDARBI

When does loss-of-exclusivity occur for EDARBI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

New Zealand

Peru

Portugal

South Korea

Spain

Taiwan

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 EDARBI around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	372116
Germany	69432644
Greece	1001386	Ετεροκυκλικές ενώσεις. (HETEROCYCLIC COMPOUNDS.)
Japan	H0753373	AGENT FOR PREVENTION OR TREATMENT OF ANGIOTENSIN II-MEDIATED DISEASES
New Zealand	549755	Benzimidazole derivative and use as AII receptor antagonist
Slovenia	1718641

Supplementary Protection Certificates for EDARBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2012C/025	Belgium		PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
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
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	C20120004 00052	Estonia		PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011

Market Dynamics and Financial Trajectory for EDARBI

Introduction to EDARBI

EDARBI, also known as azilsartan medoxomil, is an angiotensin II receptor blocker (ARB) developed by Takeda Pharmaceuticals for the treatment of hypertension in adults. It works by blocking the action of angiotensin II, a vasopressor hormone, allowing blood vessels to remain relaxed and open, thereby reducing blood pressure[3].

Market Size and Projections

The EDARBI market has been valued at USD 5 billion in 2023 and is projected to reach USD 6.8 billion by 2031, growing at a compound annual growth rate (CAGR) of 4% from 2024 to 2031. This growth is driven by several key factors, including the rising prevalence of type 2 diabetes mellitus (T2DM) and increasing healthcare expenditure globally[1].

Key Drivers of Market Growth

Rising Prevalence of T2DM

The escalating global burden of T2DM is a primary driver of the EDARBI market. As the number of diabetic patients increases, the demand for effective medications like EDARBI, which offer cardioprotective benefits alongside blood sugar control, is expected to rise[1].

Increasing Healthcare Expenditure

Growing healthcare expenditure allows for greater access to advanced diabetic medications, contributing to the market's expansion. This increased spending enables more patients to afford and access treatments like EDARBI[1].

Awareness and Treatment Access

Rising awareness about disease management among patients and physicians, along with expanding treatment access in emerging economies, are additional factors fueling market growth. The potential application of EDARBI in combination therapies for T2DM presents further growth opportunities[1].

Market Segmentation

The EDARBI market is segmented based on several criteria:

By Type

• Angiotensin II Receptor Blocker: This segment includes EDARBI and its variants.
• Tablet: EDARBI is primarily available in tablet form, with doses of 20mg, 40mg, and 80mg[1][4].

By Application

• Hypertension: The primary application of EDARBI is in the treatment of hypertension.
• Blood Pressure Control: EDARBI is used to lower blood pressure in adults, either alone or in combination with other antihypertensive agents[1].

By Geography

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics and market size[1][4].

Competitive Landscape

The EDARBI market is competitive, with several key players:

• Takeda Pharmaceutical Company: The original developer of EDARBI.
• Arbor Pharmaceuticals: Holds exclusive rights to promote and sell EDARBI and EDARBYCLOR in the United States under a licensing agreement with Takeda[3][4].
• Other Players: Include Teva Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Accord Healthcare, Glenmark Pharmaceuticals, Lupin, and Aurobindo Pharma[1].

Financial Performance and Trends

Revenue and Growth

The EDARBI market's financial trajectory is marked by steady growth. The market's value is expected to increase from USD 5 billion in 2023 to USD 6.8 billion by 2031, driven by the factors mentioned above[1].

Key Financial Metrics

• Revenue Streams: The revenue is generated through various channels, including cash pay programs, Medicare, Medicaid plans, and commercial payer plans[4].
• Geographical Performance: Different regions contribute varying amounts to the overall revenue, with North America and Europe being significant contributors due to higher healthcare spending and awareness[1][4].

Licensing and Partnerships

The licensing agreement between Takeda and Arbor Pharmaceuticals is a significant factor in the market dynamics. This agreement allows Arbor to promote and sell EDARBI and EDARBYCLOR in the United States, while Takeda focuses on its global commitment to new therapies and expanding its cardiovascular metabolic franchise[3].

Challenges and Opportunities

Challenges

• Competition: The market faces competition from other antihypertensive medications and generic versions.
• Regulatory Environment: Changes in regulatory policies can impact the market's growth.

Opportunities

• Emerging Markets: Expanding treatment access in emerging economies presents significant growth opportunities.
• Combination Therapies: The potential use of EDARBI in combination therapies for T2DM offers additional market expansion possibilities[1].

Key Takeaways

• The EDARBI market is expected to grow from USD 5 billion in 2023 to USD 6.8 billion by 2031, driven by the rising prevalence of T2DM and increasing healthcare expenditure.
• The market is segmented by type, application, and geography, with key players like Takeda and Arbor Pharmaceuticals.
• Licensing agreements and partnerships play a crucial role in market dynamics.
• Emerging markets and combination therapies offer significant growth opportunities.

FAQs

What is EDARBI used for?

EDARBI is used for the treatment of hypertension in adults, either alone or in combination with other antihypertensive agents. It works by blocking the action of angiotensin II, a vasopressor hormone, to lower blood pressure[3].

Who are the key players in the EDARBI market?

Key players include Takeda Pharmaceutical Company, Arbor Pharmaceuticals, Teva Pharmaceuticals, Sandoz, Mylan Pharmaceuticals, Accord Healthcare, Glenmark Pharmaceuticals, Lupin, and Aurobindo Pharma[1].

What is the projected growth rate of the EDARBI market?

The EDARBI market is expected to grow at a CAGR of 4% from 2024 to 2031[1].

Which regions are expected to dominate the EDARBI market?

North America and Europe are expected to be significant contributors to the EDARBI market due to higher healthcare spending and awareness[1][4].

What are the main drivers of the EDARBI market growth?

The main drivers include the rising prevalence of T2DM, increasing healthcare expenditure, and rising awareness about disease management among patients and physicians[1].

Sources

1. Market Research Intellect: Edarbi Market Size and Projections - Market Research Intellect[1].
2. EDAP Reports Third Quarter 2024 Financial Results: EDAP Reports Third Quarter 2024 Financial Results - GlobeNewswire[5].
3. Takeda and Arbor Announce a Licensing Agreement for EDARBI: Takeda and Arbor Announce a Licensing Agreement for EDARBI ... - PR Newswire[3].
4. Edarbi Market Report 2024 (Global Edition): Edarbi Market Report 2024 (Global Edition) - Cognitive Market Research[4].