Azilsartan kamedoxomil - Generic Drug Details

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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 three branded drugs marketed by Lupin Ltd and Azurity, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil has eighty-nine patent family members in thirty-six countries.

There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.

Summary for azilsartan kamedoxomil

International Patents:	89
US Patents:	5
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Patent Applications:	798
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
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	202331-001	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	202331-002	Dec 20, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Lupin Ltd	AZILSARTAN MEDOXOMIL	azilsartan kamedoxomil	TABLET;ORAL	214489-001	Jul 20, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 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	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011	⤷ Sign Up	⤷ Sign Up
>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
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.	⤷ Sign Up
Peru	20130210	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH	⤷ Sign Up
China	101677961	Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a ph control agent	⤷ Sign Up
Taiwan	I415634		⤷ Sign Up
Serbia	50537	DERIVATI BENZIMIDAZOLA I NJIHOVO KORIŠĆENJE KAO ANTAGONISTA RECEPTORA A II (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS A II RECEPTOR ANTAGONIST)	⤷ Sign Up
>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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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