AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - Generic Drug Details

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 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 seventeen patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

International Patents:	117
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
DailyMed Link:	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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.

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

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			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes			Y
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011		RX	Yes	Yes			Y

Expired US Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

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

International Patents for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Country	Patent Number	Title	Estimated Expiration
Slovenia	1718641
Canada	2732018	COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
Ecuador	SP11010856	COMPOSICIÓN FARMACÉUTICA SÓLIDA

Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012
1718641	C 2012 017	Romania		PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
2119715	2018/006	Ireland		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