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PRESTALIA Drug Profile

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Which patents cover Prestalia, and what substitute generic drugs are available?

Prestalia is a drug marketed by Symplmed Pharms Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in thirty-seven countries.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

Summary for Tradename: PRESTALIA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PRESTALIA at DailyMed
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;ORAL205003-001Jan 21, 2015RXYesNo6,696,481► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes7,846,961► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-002Jan 21, 2015RXYesNo6,696,481► SubscribeYY ► Subscribe
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
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Paragraph IV activity for: PRESTALIA

Drugname Dosage Strength RLD Submissiondate
perindopril arginine and amlodipineTablets3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mgPrestalia11/4/2016

International Patent Family for Tradename: PRESTALIA

Country Document Number Estimated Expiration
South Korea100542468► Subscribe
Poland1989182► Subscribe
Iceland2842► Subscribe
Morocco30276► Subscribe
World Intellectual Property Organization (WIPO)03087050► 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: PRESTALIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
C/GB11/010United Kingdom► SubscribePRODUCT 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
00375Netherlands► SubscribePRODUCT 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
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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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