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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 022154

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NDA 022154 describes TYZEKA, which is a drug marketed by Novartis and is included in two NDAs. Additional details are available on the TYZEKA profile page.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. Additional details are available on the telbivudine profile page.

Summary for 022154

Tradename:	TYZEKA
Applicant:	Novartis
Ingredient:	telbivudine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	100MG/5ML
Approval Date:	Apr 28, 2009	TE:		RLD:	No

Expired US Patents for NDA 022154

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	7,795,238	⤷ Get Started Free
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,395,716	⤷ Get Started Free
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	7,858,594	⤷ Get Started Free
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,569,837	⤷ Get Started Free
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,566,344	⤷ Get Started Free
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009	6,444,652	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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