Details for New Drug Application (NDA): 022545

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NDA 022545 describes TEKAMLO, which is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TEKAMLO profile page.

The generic ingredient in TEKAMLO is aliskiren hemifumarate; amlodipine besylate. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate profile page.

Summary for 022545

Tradename:	TEKAMLO
Applicant:	Novartis
Ingredient:	aliskiren hemifumarate; amlodipine besylate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022545

Generic Entry Date for 022545^: ⤷ 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 150MG BASE;EQ 5MG BASE
Approval Date:	Aug 26, 2010	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Dec 21, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE;EQ 10MG BASE
Approval Date:	Aug 26, 2010	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Dec 21, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE;EQ 5MG BASE
Approval Date:	Aug 26, 2010	TE:		RLD:	No
Patent:	⤷ Sign Up	Patent Expiration:	Dec 21, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022545

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010	⤷ Sign Up	⤷ Sign Up
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010	⤷ Sign Up	⤷ Sign Up
>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.