PRESTALIA Drug Patent Profile

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

NDA:

205003

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

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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.

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

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			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		RX	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		RX	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		RX	Yes	No			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		RX	Yes	Yes			Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		RX	Yes	Yes			Y	Y

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
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015

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

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Georgia, Republic of

Hong Kong

Hungary

Japan

Malaysia

Montenegro

Morocco

New Zealand

Norway

Poland

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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
South Africa	200301395	Salt of perindopril and pharmaceutical compositions containing it.
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)
Malaysia	151035	? CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, A PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Serbia	51694	NOVA SO PERINDOPRILA I FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE TU SO (NOVEL PERINDOPRIL SALT AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME)
Iceland	2842
Eurasian Patent Organization	200801777	α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ

Supplementary Protection Certificates for PRESTALIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300375	Netherlands		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		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785	C300486	Netherlands		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		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	C300478	Netherlands		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		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		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