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Last Updated: May 1, 2024

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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;3.5MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;7MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;14MG
Approval Date:	Jan 21, 2015	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	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	205003-003	Jan 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.