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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Argus Health
Cipla
Express Scripts
AstraZeneca
Merck
Baxter
Queensland Health
Novartis
Johnson and Johnson

Generated: October 23, 2017

DrugPatentWatch Database Preview

PRESTALIA Drug Profile

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What is the patent landscape for Prestalia, and when can generic versions of Prestalia launch?

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 seventy-three patent family members in thirty-nine countries and sixteen supplementary protection certificates in eight countries.

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty 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

US 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 TE 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, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-002Jan 21, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-001Jan 21, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-001Jan 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-002Jan 21, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-002Jan 21, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Symplmed Pharms Llc
PRESTALIA
amlodipine besylate; perindopril arginine
TABLET;ORAL205003-003Jan 21, 2015RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
South Africa200807024► Subscribe
Australia2003222921► Subscribe
Malaysia151035► Subscribe
Austria271036► Subscribe
Spain2581982► Subscribe
CroatiaP20160644► Subscribe
France2897866► Subscribe
South Korea20030082902► Subscribe
Georgia, Republic ofP20125433► 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
2011 00026Denmark► SubscribePRODUCT 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
07C/043Belgium► SubscribePRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
C0048France► SubscribePRODUCT 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
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
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
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
00528Netherlands► SubscribePRODUCT 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
00478Netherlands► SubscribePRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
12/018Ireland► SubscribePRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983/03Switzerland► SubscribePRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Argus Health
Farmers Insurance
Federal Trade Commission
Healthtrust
Chinese Patent Office
Queensland Health
Covington
US Department of Justice

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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