Telbivudine - Generic Drug Details

What are the generic sources for telbivudine and what is the scope of patent protection?

Telbivudine is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telbivudine has eleven patent family members in seven countries.

There are two drug master file entries for telbivudine.

Summary for telbivudine

International Patents:	11
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	83
Patent Applications:	4,929
Formulation / Manufacturing:	see details
DailyMed Link:	telbivudine at DailyMed

Recent Clinical Trials for telbivudine

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

Sponsor	Phase
Mahidol University	Phase 4
Lai Wei	Phase 2
Beijing Ditan Hospital	Phase 4

See all telbivudine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for telbivudine

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 telbivudine

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	TABLET;ORAL	022011-001	Oct 25, 2006		DISCN	Yes	No			Y	Y
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009		DISCN	No	No			Y	Y
Novartis	TYZEKA	telbivudine	TABLET;ORAL	022011-001	Oct 25, 2006		DISCN	Yes	No			Y	Y

Expired US Patents for telbivudine

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	SOLUTION;ORAL	022154-001	Apr 28, 2009
Novartis	TYZEKA	telbivudine	SOLUTION;ORAL	022154-001	Apr 28, 2009

EU/EMA Drug Approvals for telbivudine

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 telbivudine

Country	Patent Number	Title	Estimated Expiration
China	1714098	Crystalline and amorphous forms of beta-l-2'-deoxythymidine
European Patent Office	2607370	Procédé pour identifier une forme amorphe de beta-L-2'-déoxythymidine (Method for identifying an amorphous form of beta-L-2'-deoxythymidine)
South Korea	20050083619	CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE

Supplementary Protection Certificates for telbivudine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C300286	Netherlands		PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
1104436	CA 2007 00038	Denmark		PRODUCT NAME: TELBIVUDINE