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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PRESTALIA
*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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-002 | Jan 21, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-003 | Jan 21, 2015 | DISCN | Yes | No | ⤷ 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 |
|---|---|---|---|
| European Patent Office | 1989182 | 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) | ⤷ Sign Up |
| Iceland | 7516 | Nýtt salt peridópríls og lyfjablöndur sem innihalda það | ⤷ Sign Up |
| Australia | 2007220435 | Alpha crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it | ⤷ Sign Up |
| China | 1451656 | Novel salt of perindopril and pharmaceutical composition contg. same | ⤷ Sign Up |
| Montenegro | 02456 | 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) | ⤷ Sign Up |
| Norway | 20083535 | ⤷ Sign Up | |
| Hong Kong | 1129669 | ⤷ 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 1003503 | 05C0048 | France | ⤷ Sign Up | 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 |
| 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 |
| >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.
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