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PRESTALIA Drug Profile

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When do Prestalia patents expire, and when can generic versions of Prestalia launch?

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. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

Summary for PRESTALIA

International Patents:	75
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRESTALIA
DailyMed Link:	PRESTALIA at DailyMed

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.

Pharmacology for PRESTALIA

Drug Class	Angiotensin Converting Enzyme Inhibitor Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists

Synonyms for PRESTALIA

1265624-53-0

Amlodipine / perindopril

Amlodipine and perindopril

Amlodipine besylate / with perindopril arginine

Amlodipine besylate mixture with perindopril arginine

Coveram

Perindopril arginine mixture with amlodipine besylate

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

Paragraph IV (Patent) Challenges for PRESTALIA

Drugname	Dosage	Strength	RLD	Date
	Tablets	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg

International Patents for PRESTALIA

Country	Patent Number	Estimated Expiration
Spain	2581982
South Africa	200807024
Cyprus	1117753

Supplementary Protection Certificates for PRESTALIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	C300528	Netherlands		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
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
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016