AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - Generic Drug Details

What are the generic sources for amlodipine besylate; perindopril arginine and what is the scope of freedom to operate?

Amlodipine besylate; perindopril arginine is the generic ingredient in one branded drug marketed by Adhera and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; perindopril arginine has thirty patent family members in twenty-seven countries.

Summary for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

International Patents:	30
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
DailyMed Link:	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

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.

Recent Clinical Trials for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Symplmed Pharmaceuticals LLC	Phase 3

See all AMLODIPINE BESYLATE; PERINDOPRIL ARGININE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRESTALIA	Tablets	amlodipine besylate; perindopril arginine	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg	205003	1	2016-11-04

US Patents and Regulatory Information for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No			Y	Y

Expired US Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015

International Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Country	Patent Number	Title	Estimated Expiration
Serbia	54754	KRISTALNI OBLIK ARGININSKE SOLI PERINDOPRILA, POSTUPAK NJENE PROIZVODNJE I FARMACEUTSKE SMEŠE KOJE JE SADRŽE (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Eurasian Patent Organization	200801777	α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ
Japan	2009534295
Eurasian Patent Organization	014716	α-КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ (α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Spain	2581982
Australia	2007220435	Alpha crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Denmark	1989182

Supplementary Protection Certificates for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
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: CH - 6167801 20110705
1915993	300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216