TYZEKA Drug Patent Profile

Which patents cover Tyzeka, and what generic alternatives are available?

Tyzeka is a drug marketed by Novartis and is included in two NDAs.

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 TYZEKA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	5
Patent Applications:	3,149
Formulation / Manufacturing:	see details
DailyMed Link:	TYZEKA at DailyMed

Recent Clinical Trials for TYZEKA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chinese University of Hong Kong	N/A
Novartis	Phase 4
Novartis Pharmaceuticals	Phase 3

See all TYZEKA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TYZEKA

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TYZEKA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009		DISCN	No	No
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006		DISCN	Yes	No

Expired US Patents for TYZEKA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009

EU/EMA Drug Approvals for TYZEKA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Sebivo	telbivudine	EMEA/H/C/000713 Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.	Withdrawn	no	no	no	2007-04-24

International Patents for TYZEKA

See the table below for patents covering TYZEKA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20050062664
Cyprus	1116988
China	1320128
Australia	2003265396	CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE

Supplementary Protection Certificates for TYZEKA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1104436	C01104436/01	Switzerland		FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
1104436	07C0046	France		PRODUCT NAME: TELBIVUDINE (DC1); REGISTRATION NO/DATE IN FRANCE: EU/1/07/388/001 DU 20070424; REGISTRATION NO/DATE AT EEC: EU/1/07/388/001 DU 20070424
1104436	39/2007	Austria		PRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
1104436	SPC/GB07/058	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/058 GRANTED TO NOVARTIS AG, CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE AND L UNIVERSITE MONTPELLIER II IN RESPECT OF THE PRODUCT TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6311 DATED 05 MAY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 25 APRIL 2022.