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
Summary for PRESTALIA
International Patents: | 75 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Patent Applications: | 3 |
Formulation / Manufacturing: | see details |
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 |

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.
Anatomical Therapeutic Chemical (ATC) Classes for PRESTALIA
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
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 |