Last Updated: November 9, 2026

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - Generic Drug Details

Name: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of freedom to operate?

Azilsartan kamedoxomil; chlorthalidone is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd and Azurity, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

International Patents:	49
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
DailyMed Link:	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE at DailyMed

Pharmacology for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	217490-001	Jan 21, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	AB	RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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 AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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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	⤷ Start Trial
Australia	2008235790	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent	⤷ Start Trial
Brazil	PI0809522	COMPOSIÇÃO FARMACÊUTICA SÓLIDA, MÉTODOS PARA ESTABILIZAR UM COMPOSTO, E PARA MELHORAR DISSOLUÇÃO DE UM COMPOSTO, E, USO DE UM AGENTE DE CONTROLE DE PH.	⤷ Start Trial
Canada	2681143	COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)	⤷ Start Trial
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.	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	132012902056823	Italy	⤷ Start Trial	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	C300525	Netherlands	⤷ Start Trial	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	SPC/GB12/028	United Kingdom	⤷ Start Trial	PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
1718641	2012/008	Ireland	⤷ Start Trial	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	C01718641/01	Switzerland	⤷ Start Trial	PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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