~ Buy the EDARBYCLOR (azilsartan kamedoxomil; chlorthalidone) Drug Profile, 2024 PDF Report in the Report Store ~

EDARBYCLOR Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for EDARBYCLOR?
What are the global sales for EDARBYCLOR?
What is Average Wholesale Price for EDARBYCLOR?

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

Drug patent expirations by year for EDARBYCLOR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EDARBYCLOR

Generic Entry Date for EDARBYCLOR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 202331 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

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.

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

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EDARBYCLOR

Benzimidazole derivative and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Benzimidazole derivative and use as a II receptor antagonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION

Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	⤷ Sign Up	⤷ Sign Up
>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: ⤷ Sign Up

Australia

Patent: 09277455
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Brazil

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

Canada

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

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: ⤷ Sign Up

China

Patent: 2164918
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 41633
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 110111
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 011000032
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 11010856
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 1170273
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up

European Patent Office

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

Georgia, Republic of

Patent: 0146062
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 35491
Estimated Expiration: ⤷ Sign Up

Patent: 11529444
Estimated Expiration: ⤷ Sign Up

Mexico

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

Morocco

Patent: 553
Patent: تركيب صيدلاني صلب
Estimated Expiration: ⤷ Sign Up

New Zealand

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

Peru

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

Portugal

Patent: 10385
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1100871
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 110038145
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 1008915
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 11000045
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up

Ukraine

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

Uruguay

Patent: 017
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷ Sign Up

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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005080384		⤷ Sign Up
European Patent Office	1718641	DERIVES DE BENZIMIDAZOLE ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR A II (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS A II RECEPTOR ANTAGONIST)	⤷ Sign Up
Germany	602005016162		⤷ Sign Up
Cyprus	1107008		⤷ Sign Up
Japan	2005272451	BENZIMIDAZOLE DERIVATIVE AND ITS USE	⤷ Sign Up
Norway	20064251		⤷ Sign Up
Norway	300734		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EDARBYCLOR

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	SPC/GB12/028	United Kingdom	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1718641	436	Finland	⤷ Sign Up
2119715	300802	Netherlands	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	2012C/025	Belgium	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209
1718641	C300525	Netherlands	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
1718641	C01718641/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	12C0034	France	⤷ Sign Up	PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description