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Telbivudine - Generic Drug Details

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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telbivudine has sixty patent family members in twenty-one countries.

There are two drug master file entries for telbivudine.

Summary for telbivudine

International Patents:	60
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Bulk Api Vendors:	69
Clinical Trials:	79
Patent Applications:	3,280
Formulation / Manufacturing:	see details
DailyMed Link:	telbivudine at DailyMed

Recent Clinical Trials for telbivudine

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

Sponsor	Phase
Beijing Ditan Hospital	Phase 4
Sun Yat-sen University	Phase 2
National Medical Research Council (NMRC), Singapore	Phase 4

See all telbivudine clinical trials

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

International Patents for telbivudine

Country	Patent Number	Estimated Expiration
Taiwan	I244393
Spain	2531928
South Korea	20080032260
South Korea	100691737
South Korea	100702230

Supplementary Protection Certificates for telbivudine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1104436	300286	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
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	CA 2007 00038	Denmark		PRODUCT NAME: TELBIVUDINE
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	307	Finland