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Last Updated: October 7, 2024

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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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven 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
International Patents:30
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 2
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for PRESTALIA
What excipients (inactive ingredients) are in PRESTALIA?PRESTALIA excipients list
DailyMed Link:PRESTALIA at DailyMed
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 one US patents.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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

.alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharmaceutical compositions containing it
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-003 Jan 21, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-003 Jan 21, 2015 ⤷  Sign Up ⤷  Sign Up
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 ⤷  Sign Up ⤷  Sign Up
>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
Patent: Alpha crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0708278
Patent: forma cristalina alfa do sal arginina do perindopril, o respectivo processo de preparação, e as composições farmacêuticas que a contêm
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 44467
Patent: FORME CRISTALLINE A DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (A CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1389603
Patent: Crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160644
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17753
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 89182
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4716
Patent: α-КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ (α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Estimated Expiration: ⤷  Sign Up

Patent: 0801777
Patent: α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 89182
Patent: FORME CRISTALLINE DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Estimated Expiration: ⤷  Sign Up

France

Patent: 97866
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0125433
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 29669
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27898
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 55454
Estimated Expiration: ⤷  Sign Up

Patent: 09534295
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1035
Patent: ? CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 456
Patent: KRISTALNI OBLIK ARGININSKE SOLI PERINDOPRILA, POSTUPAK NJENE PROIZVODNJE I FARMACEUTSKE SMEŠE KOJE JE SADRŽE (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 276
Patent: FORME CRISTALLINE ALPHA DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0367
Patent: A crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 083535
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 89182
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 754
Patent: KRISTALNI OBLIK ARGININSKE SOLI PERINDOPRILA, POSTUPAK NJENE PROIZVODNJE I FARMACEUTSKE SMEŠE KOJE JE SADRŽE (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 89182
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0807024
Patent: Alpha crystaline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 080106948
Patent: ALPHA; CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT
Estimated Expiration: ⤷  Sign Up

Patent: 120001818
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 81982
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 905
Patent: α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕЕ СОДЕРЖИТ;α-КРИСТАЛІЧНА ФОРМА АРГІНІНОВОЇ СОЛІ ПЕРИНДОПРИЛУ, СПОСІБ ЇЇ ОДЕРЖАННЯ І ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЇЇ МІСТИТЬ (α-CRYSTALLINE FORM OF PERINDOPRIL ARGININE SALT, METHOD FOR MAKING SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME)
Estimated Expiration: ⤷  Sign Up

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
Japan 2003321493 NEW PERINDOPRIL SALT AND PHARMACEUTICAL COMPOSITION CONTAINING THE SAME ⤷  Sign Up
China 1451656 Novel salt of perindopril and pharmaceutical composition contg. same ⤷  Sign Up
Spain 2581982 ⤷  Sign Up
Morocco 30276 FORME CRISTALLINE ALPHA DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT ⤷  Sign Up
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) ⤷  Sign Up
Australia 2003200700 ⤷  Sign Up
New Zealand 570367 A crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRESTALIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C300528 Netherlands ⤷  Sign Up 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
0502314 C300478 Netherlands ⤷  Sign Up 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
0678503 C300499 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0443983 C300445 Netherlands ⤷  Sign Up PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1915993 300625 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0503785 CA 2011 00026 Denmark ⤷  Sign Up 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
1507558 12C0033 France ⤷  Sign Up PRODUCT 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: CH - 6167801 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.