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Last Updated: April 19, 2024

AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - Generic Drug Details

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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

Generic Entry Date for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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

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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
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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 AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

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

International Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

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Country	Patent Number	Title	Estimated Expiration
Denmark	1989182		⤷ Try a Trial
Norway	20083535		⤷ Try a Trial
Japan	2009534295		⤷ Try a Trial
New Zealand	570367	A crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1003503	05C0048	France	⤷ Try a Trial	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
0502314	SPC/GB11/010	United Kingdom	⤷ Try a Trial	PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0678503	C300499	Netherlands	⤷ Try a Trial	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
0443983	C300445	Netherlands	⤷ Try a Trial	PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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