Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details

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What are the generic drug sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of patent protection?

Azilsartan kamedoxomil; chlorthalidone is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Azilsartan kamedoxomil; chlorthalidone has one hundred and nineteen patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for azilsartan kamedoxomil; chlorthalidone

International Patents:	119
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
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
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	See Plans and Pricing	See Plans and Pricing		Y		See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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	202331-002	Dec 20, 2011	See Plans and Pricing	See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	See Plans and Pricing	See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-001	Dec 20, 2011	See Plans and Pricing	See Plans and Pricing
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	See Plans and Pricing	See Plans and Pricing
>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
Denmark	1718641		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2010075347		See Plans and Pricing
Netherlands	300802		See Plans and Pricing
Japan	2009137974	BENZIMIDAZOLE DERIVATIVE AND USE THEREOF	See Plans and Pricing
Montenegro	01643	DERIVATI BENZIMIDAZOLA I NJIHOVO KORIŠĆENJE KAO ANTAGONISTA RECEPTORA A II (BENZIMIDAZOLE DERIVATIVE AND USE AS AII RECEPTOR ANTAGONIST)	See Plans and Pricing
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.	See Plans and Pricing
Mexico	2011001150	COMPOSICION FARMACEUTICA SOLIDA. (SOLID PHARMACEUTICAL COMPOSITION.)	See Plans and Pricing
>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	436	Finland	See Plans and Pricing
1718641	C20120005 00053	Estonia	See Plans and Pricing	PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
1718641	PA2012004	Lithuania	See Plans and Pricing	PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207
2119715	300802	Netherlands	See Plans and Pricing	PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	91962	Luxembourg	See Plans and Pricing	91962, EXPIRES: 20261207
2119715	2018/006	Ireland	See Plans and Pricing	PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
1718641	SPC/GB12/028	United Kingdom	See Plans and Pricing	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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