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Amlodipine benzoate - Generic Drug Details

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What are the generic drug sources for amlodipine benzoate and what is the scope of patent protection?

Amlodipine benzoate 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.

Amlodipine benzoate has seven patent family members in four countries.

There are fifty drug master file entries for amlodipine benzoate. One supplier is listed for this compound.

Summary for amlodipine benzoate

International Patents:	7
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	50
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	10
DailyMed Link:	amlodipine benzoate at DailyMed

Pharmacology for amlodipine benzoate

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
KATERZIA	SUSPENSION;ORAL	amlodipine benzoate	211340	2020-12-29

US Patents and Regulatory Information for amlodipine benzoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes			Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes

International Patents for amlodipine benzoate

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019200143
European Patent Office	3522872
China	112334134
European Patent Office	3773574

Supplementary Protection Certificates for amlodipine benzoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785	C300375	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009