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Last Updated: December 9, 2023

PRESTALIA Drug Patent Profile


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When do Prestalia patents expire, and what generic alternatives are available?

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

This drug has seventy-five 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. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

DrugPatentWatch® Generic Entry Outlook for Prestalia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 5, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for PRESTALIA
Drug patent expirations by year for PRESTALIA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PRESTALIA
Generic Entry Date for PRESTALIA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Paragraph IV (Patent) Challenges for PRESTALIA
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 PRESTALIA

PRESTALIA is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PRESTALIA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PRESTALIA

Salt of perindopril and pharmaceutical compositions containing it
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTENSION

.alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTENSION

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 205003-002 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 205003-001 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 205003-002 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 205003-003 Jan 21, 2015 RX Yes Yes ⤷  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 PRESTALIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 205003-003 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 PRESTALIA

When does loss-of-exclusivity occur for PRESTALIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07220435
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0708278
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 44467
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1389603
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160644
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17753
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 89182
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 4716
Estimated Expiration: ⤷  Try a Trial

Patent: 0801777
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 89182
Estimated Expiration: ⤷  Try a Trial

France

Patent: 97866
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0125433
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 29669
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27898
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 55454
Estimated Expiration: ⤷  Try a Trial

Patent: 09534295
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1035
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 456
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 276
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0367
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 083535
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 89182
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 754
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 89182
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0807024
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 080106948
Estimated Expiration: ⤷  Try a Trial

Patent: 120001818
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 81982
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 905
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PRESTALIA around the world.

Country Patent Number Title Estimated Expiration
Brazil PI0708278 forma cristalina alfa do sal arginina do perindopril, o respectivo processo de preparação, e as composições farmacêuticas que a contêm ⤷  Try a Trial
South Africa 200301395 Salt of perindopril and pharmaceutical compositions containing it. ⤷  Try a Trial
France 2897866 FORME CRISTALLINE ALPHA DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (New alpha crystalline form of perindopril arginine salt are angiotensin I converting enzyme inhibitor, useful for the manufacture of drugs to treat cardiovascular diseases) ⤷  Try a Trial
Malaysia 151035 ? CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT ⤷  Try a Trial
Serbia 51694 NOVA SO PERINDOPRILA I FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE TU SO (NOVEL PERINDOPRIL SALT AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME) ⤷  Try a Trial
Iceland 2842 ⤷  Try a Trial
Eurasian Patent Organization 200801777 α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRESTALIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 C300375 Netherlands ⤷  Try a Trial PRODUCT 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
1915993 92315 Luxembourg ⤷  Try a Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785 C300486 Netherlands ⤷  Try a Trial PRODUCT 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
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314 C300478 Netherlands ⤷  Try a Trial PRODUCT 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
1507558 2012/018 Ireland ⤷  Try a 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Boehringer Ingelheim
Baxter
Harvard Business School
Medtronic

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