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Last Updated: January 18, 2021

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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

SponsorPhase
Beijing Ditan HospitalPhase 4
Sun Yat-sen UniversityPhase 2
National Medical Research Council (NMRC), SingaporePhase 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   Start Trial   Start Trial   Start Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No   Start Trial   Start Trial Y Y   Start Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for telbivudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1104436 300286 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1104436 07C0046 France   Start Trial 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   Start Trial PRODUCT NAME: TELBIVUDINE
1104436 C300286 Netherlands   Start Trial PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
1104436 307 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Colorcon
Medtronic
Express Scripts
Boehringer Ingelheim

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