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Amlodipine besylate; perindopril arginine - Generic Drug Details

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

This ingredient has sixty-two patent family members in thirty-six countries.

There are forty-nine drug master file entries for amlodipine besylate; perindopril arginine. One supplier is listed for this compound.

Summary for Generic Name: amlodipine besylate; perindopril arginine

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list49
Suppliers / Packagers: see list1
Clinical Trials: see list261
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; perindopril arginine at DailyMed

Pharmacology for Ingredient: amlodipine besylate; perindopril arginine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes6,696,481► subscribeYY ► subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-001Jan 21, 2015RXYesNo7,846,961► subscribeYY ► subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes7,846,961► subscribeYY ► subscribe
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International Patent Family for Ingredient: amlodipine besylate; perindopril arginine

Country Document Number Estimated Expiration
Costa Rica7576► subscribe
Portugal1354873► subscribe
Brazil0300709► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0033France► subscribePRODUCT 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
315Luxembourg► subscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
00486Netherlands► subscribePRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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