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:	5
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	7,572,920		Y
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	202331-001	Dec 20, 2011	AB	RX	Yes	No	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	7,157,584			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	9,387,249
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	7,157,584			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	5,583,141
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,572,920
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,583,141
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	5,736,555
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	7,572,920
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	5,736,555

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
Austria	E370136
Austria	E440095
Peru	20130210	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH
Poland	1857457
Portugal	1857457
Slovenia	2119715

Supplementary Protection Certificates for EDARBYCLOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	436	Finland
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641	CA 2012 00013	Denmark
1718641	PA2012004,C1718641	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

Market Dynamics and Financial Trajectory for EDARBYCLOR

Introduction to EDARBYCLOR

EDARBYCLOR, a fixed-dose combination of azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a thiazide-like diuretic, is a significant medication in the treatment of hypertension. Here, we will delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Milestones

EDARBYCLOR was approved by the U.S. Food and Drug Administration (FDA) in December 2011 for the treatment of hypertension to lower blood pressure in adults[4].

Recent Developments

In 2024, Zydus Lifesciences Limited received tentative approval from the FDA to market Azilsartan Medoxomil and Chlorthalidone Tablets under the brand name Edarbyclor®, marking a significant entry into the U.S. market for this generic version of the medication. This approval is expected to increase affordability for patients and contribute to the reduction of healthcare costs associated with treating high blood pressure[3].

Market Opportunity

Prevalence of Hypertension

Hypertension is a global health concern, affecting millions of people worldwide. The demand for effective and affordable treatments is high, making EDARBYCLOR a valuable asset in the pharmaceutical market.

Sales and Revenue

As of March 2024, Azilsartan Medoxomil and Chlorthalidone Tablets had an existing annual sales value of USD 77.9 million in the United States alone, indicating a substantial market opportunity[3].

Licensing and Distribution Agreements

Takeda and Arbor Pharmaceuticals

In 2013, Takeda Pharmaceutical Company Limited and Arbor Pharmaceuticals entered into a license, development, and commercialization agreement. Under this agreement, Arbor gained exclusive rights to market and sell EDARBI (azilsartan medoxomil) and EDARBYCLOR in the U.S. market. Takeda received an upfront payment along with future milestone and royalty payments based on sales of these products[1].

Financial Performance

Revenue Growth

The introduction of EDARBYCLOR has contributed to the revenue growth of pharmaceutical companies involved in its distribution. For instance, the licensing agreement between Takeda and Arbor allowed Takeda to optimize its commercial resources while ensuring continued availability of EDARBYCLOR in the U.S. market[1].

Generic Competition

The entry of generic versions, such as the one by Zydus, is expected to increase competition, potentially affecting the pricing and market share of the original branded product. However, this competition can also drive down costs and make the medication more accessible to a wider patient population[3].

Clinical Efficacy and Market Position

Superior Blood Pressure Reduction

Studies have shown that EDARBYCLOR exhibits superior blood pressure reductions compared to other commonly used combination treatments. For example, a 12-week study demonstrated that EDARBYCLOR reduced clinic systolic blood pressure by 42.5 mm Hg from baseline, significantly more than the reduction seen with a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide[4].

Patient and Healthcare Provider Acceptance

The efficacy and safety profile of EDARBYCLOR have made it a preferred option for patients and healthcare providers. Its use as both a monotherapy and as part of an initial therapy regimen for patients likely to need multiple drugs to achieve blood pressure goals further solidifies its market position[1][4].

Challenges and Considerations

Adverse Reactions and Drug Interactions

EDARBYCLOR, like other medications, comes with potential adverse reactions such as dizziness, fatigue, and hypokalemia. These factors must be considered in the overall market strategy and patient management plans[1].

Regulatory and Formulary Status

EDARBYCLOR is not on the VA national formulary and requires a non-formulary drug request and prior approval to be dispensed, which can affect its accessibility in certain healthcare settings[5].

Future Outlook

Generic Market Expansion

The approval of generic versions by companies like Zydus is expected to expand the market reach of EDARBYCLOR, making it more affordable and accessible to a broader patient population. This expansion could lead to increased market share and revenue for generic manufacturers[3].

Continued Innovation

Pharmaceutical companies like Takeda continue to innovate and explore new approaches for managing chronic diseases. The success of EDARBYCLOR underscores the importance of combining existing therapies to create new treatment options, which could lead to further innovations in the hypertension treatment market[4].

Key Takeaways

• Regulatory Approvals: EDARBYCLOR has received FDA approval and recent generic approvals, ensuring its continued presence in the market.
• Market Opportunity: The high prevalence of hypertension and the existing annual sales value of USD 77.9 million in the U.S. indicate a substantial market opportunity.
• Licensing Agreements: Agreements between Takeda and Arbor, and the entry of generic manufacturers like Zydus, have shaped the market dynamics.
• Clinical Efficacy: EDARBYCLOR has demonstrated superior blood pressure reductions, making it a preferred treatment option.
• Financial Performance: The drug contributes to revenue growth for involved pharmaceutical companies, with potential impacts from generic competition.

FAQs

Q: What is EDARBYCLOR used for?

EDARBYCLOR is used for the treatment of hypertension to lower blood pressure in adults. It combines azilsartan medoxomil, an angiotensin II receptor blocker (ARB), and chlorthalidone, a thiazide-like diuretic[1][4].

Q: Who are the key players in the EDARBYCLOR market?

Key players include Takeda Pharmaceutical Company Limited, Arbor Pharmaceuticals, and Zydus Lifesciences Limited, which has recently received FDA approval for a generic version[1][3].

Q: What are the potential side effects of EDARBYCLOR?

Common adverse reactions include dizziness, fatigue, and hypokalemia. Other potential side effects include hyperuricemia and gout[1].

Q: How does EDARBYCLOR compare to other hypertension treatments?

EDARBYCLOR has shown superior blood pressure reductions compared to other commonly used combination treatments, such as the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide[4].

Q: Is EDARBYCLOR available on the VA national formulary?

No, EDARBYCLOR is not on the VA national formulary and requires a non-formulary drug request and prior approval to be dispensed[5].

Sources

1. Takeda and Arbor Announce a Licensing Agreement for EDARBI and EDARBYCLOR. Takeda Pharmaceutical Company Limited. September 12, 2013.
2. Better health. Within reach. Every day. Hikma Pharmaceuticals PLC. 2021.
3. Zydus Gains USFDA Nod for Edarbyclor® Tablets. Angel One. June 21, 2024.
4. Edarbyclor (azilsartan medoxomil and chlorthalidone) Head-to-Head Data Published in Hypertension. Takeda Pharmaceutical Company Limited. June 18, 2012.
5. AZILSARTAN/ CHLORTHALIDONE TAB. VA Formulary Advisor.