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Last Updated: December 25, 2024

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EDARBYCLOR Drug Patent Profile


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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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 4, 2030. This may change due to patent challenges or generic licensing.

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

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Drug patent expirations by year for EDARBYCLOR
Drug Prices for EDARBYCLOR

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDARBYCLOR
Generic Entry Date for EDARBYCLOR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EDARBYCLOR

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

SponsorPhase
TakedaPhase 3

See all EDARBYCLOR clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDARBYCLOR is ⤷  Subscribe.

This potential generic entry date is based on patent 9,169,238.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 7,572,920 ⤷  Subscribe Y ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes 9,387,249 ⤷  Subscribe ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No 9,169,238 ⤷  Subscribe Y ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes 7,157,584 ⤷  Subscribe Y ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No 9,387,249 ⤷  Subscribe ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 RX Yes No 7,157,584 ⤷  Subscribe Y ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 RX Yes Yes 7,572,920 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 5,583,141 ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-002 Dec 20, 2011 5,736,555 ⤷  Subscribe
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 5,736,555 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 2883
Patent: COMPOSICIoN FARMACÉUTICA SoLIDA CON EL COMPUESTO (5-METIL-2-OXO-1,3-DIOXOL-4-IL)METIL2-ETOXI-1-{[2' -(5-OXO-4,5-DIHIDRO-1,2,4-OXADIAZOL-3-IL)BIFENIL-4-IL]METIL}-1H-BENCIMIDAZOL-7-CARBOXILATO Y UN DIURÉTICO PARA LA PROFILAXIS O TRATAMIENTO DE ENFERMEDADES DEL APARATO CIRCULATORIO.
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 09277455
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0916847
Patent: preparação sólida, e, métodos para estabilizar um composto e para melhorar a propriedade de dissolução de um composto.
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 32018
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 11000187
Patent: Preparacion farmaceutica que comprende (5-metil-2-oxo-1,3-dioxol-4il)metil 2-etoxi-1-{[2,{5-oxo-4,5-dihidro-1,2,4-oxadiazol-3-il)bifenil4il]metil}-1h-benzimidazol-7-carboxilato, un agente de control de ph entre 2 y 5 y un diuretico; metodo para estabilizar; metodo para mejorar disolucion, util en enfermedades inducidas por angiotensina ii.
Estimated Expiration: ⤷  Subscribe

China

Patent: 2164918
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 41633
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 110111
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷  Subscribe

Dominican Republic

Patent: 011000032
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 11010856
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 1170273
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 10385
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Subscribe

Georgia, Republic of

Patent: 0146062
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 35491
Estimated Expiration: ⤷  Subscribe

Patent: 11529444
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 11001150
Patent: COMPOSICION FARMACEUTICA SOLIDA. (SOLID PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 553
Patent: تركيب صيدلاني صلب
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 0948
Patent: SOLID PHARMACEUTICAL COMPOSITION COMPRISING A DIURETIC, PH CONTROL AGENT AND AN OXADIAZOLE
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 110551
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE CONTIENE UN DERIVADO DE BENCIMIDAZOL Y UN DIURETICO
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 10385
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1100871
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 110038145
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 1008915
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 11000045
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 3905
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ;ТВЕРДА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 017
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷  Subscribe

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
Argentina 065850 COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENZIMIDAZOL-7-CARBOXILATO Y UN AGENTE DE CONTROL DE PH ⤷  Subscribe
Norway 922495 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2010075347 ⤷  Subscribe
Austria E370136 ⤷  Subscribe
Singapore 65550 Heterocyclic compounds their production and use as angiotensin ii antagonists ⤷  Subscribe
Morocco 32553 تركيب صيدلاني صلب ⤷  Subscribe
South Korea 20070020411 BENZIMIDAZOLE DERIVATIVE AND USE THEREOF ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EDARBYCLOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1718641 436 Finland ⤷  Subscribe
1718641 C01718641/01 Switzerland ⤷  Subscribe PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641 121 5004-2012 Slovakia ⤷  Subscribe PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641 C20120004 00052 Estonia ⤷  Subscribe PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011
1718641 2012/008 Ireland ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
2119715 300802 Netherlands ⤷  Subscribe PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

EDARBYCLOR Market Analysis and Financial Projection Experimental

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.