Last Updated: November 9, 2026

Azilsartan kamedoxomil - Generic Drug Details

Name: azilsartan kamedoxomil 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 and what is the scope of patent protection?

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

Three suppliers are listed for this compound.

Summary for azilsartan kamedoxomil

International Patents:	21
US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	114
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azilsartan kamedoxomil
What excipients (inactive ingredients) are in azilsartan kamedoxomil?	azilsartan kamedoxomil excipients list
DailyMed Link:	azilsartan kamedoxomil at DailyMed

Pharmacology for azilsartan kamedoxomil

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 AZILSARTAN KAMEDOXOMIL

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 azilsartan kamedoxomil

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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
Lupin	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-001	Jul 20, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ 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	Y			⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Start Trial	⤷ Start Trial
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for azilsartan kamedoxomil

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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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for azilsartan kamedoxomil

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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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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