Details for New Drug Application (NDA): 205003

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NDA 205003 describes PRESTALIA, which is a drug marketed by Adhera and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PRESTALIA profile page.

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.

Summary for 205003

Tradename:	PRESTALIA
Applicant:	Adhera
Ingredient:	amlodipine besylate; perindopril arginine
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 205003

Generic Entry Date for 205003^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;3.5MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 5, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HYPERTENSION

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;7MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 5, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HYPERTENSION

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;14MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 5, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HYPERTENSION

Expired US Patents for NDA 205003

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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

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