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Last Updated: September 25, 2022

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 Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-002 Jan 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Adhera PRESTALIA amlodipine besylate; perindopril arginine TABLET;ORAL 205003-001 Jan 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

Brazil

Patent: 0708278
Estimated Expiration: See Plans and Pricing

Canada

Patent: 44467
Estimated Expiration: See Plans and Pricing

China

Patent: 1389603
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160644
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17753
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 89182
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4716
Estimated Expiration: See Plans and Pricing

Patent: 0801777
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89182
Estimated Expiration: See Plans and Pricing

France

Patent: 97866
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0125433
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 29669
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27898
Estimated Expiration: See Plans and Pricing

Japan

Patent: 55454
Estimated Expiration: See Plans and Pricing

Patent: 09534295
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1035
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 456
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 276
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0367
Estimated Expiration: See Plans and Pricing

Norway

Patent: 083535
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89182
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 754
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89182
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0807024
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 080106948
Estimated Expiration: See Plans and Pricing

Patent: 120001818
Estimated Expiration: See Plans and Pricing

Spain

Patent: 81982
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 905
Estimated Expiration: See Plans and Pricing

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
Canada 2644467 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) See Plans and Pricing
Hungary E027898 See Plans and Pricing
Spain 2581982 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRESTALIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 C300625 Netherlands See Plans and Pricing 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
0502314 C300478 Netherlands See Plans and Pricing 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 See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
Medtronic

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.