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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
US Army
AstraZeneca
Teva
Chubb
McKinsey
Colorcon
Julphar
UBS

Generated: April 25, 2018

DrugPatentWatch Database Preview

PRESTALIA Drug Profile

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When do Prestalia patents expire, and when can generic versions of Prestalia launch?

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

This drug has seventy-four patent family members in forty 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.

US Patents and Regulatory Information for PRESTALIA

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

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Paragraph IV (Patent) Challenges for PRESTALIA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg ➤ Subscribe 2016-11-04

Supplementary Protection Certificates for PRESTALIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00528 Netherlands ➤ Try a Free Trial 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
2011 00026 Denmark ➤ Try a Free Trial 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
12/018 Ireland ➤ Try a Free Trial PRODUCT 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
0443983/03 Switzerland ➤ Try a Free Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKesson
Merck
Express Scripts
Moodys
Chubb
QuintilesIMS
McKinsey
AstraZeneca

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