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PRESTALIA Drug 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:	1
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 Generic Entry Opportunity 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.

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	NDA	Submissiondate
PRESTALIA	TABLET;ORAL	amlodipine besylate; perindopril arginine	205003	2016-11-04

US Patents and Regulatory Information for 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

International Patents for PRESTALIA

Country	Patent Number	Estimated Expiration
Serbia	51694
Norway	20030849
European Patent Office	1354873

Supplementary Protection Certificates for PRESTALIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222