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Last Updated: August 14, 2022

Telbivudine - Generic Drug Details


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What are the generic sources for telbivudine and what is the scope of freedom to operate?

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
Recent Clinical Trials for telbivudine

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

SponsorPhase
Mahidol UniversityPhase 4
Lai WeiPhase 2
Beijing Ditan HospitalPhase 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 TABLET;ORAL 022011-001 Oct 25, 2006 See Plans and Pricing See Plans and Pricing
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 See Plans and Pricing See Plans and Pricing
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 See Plans and Pricing See Plans and Pricing
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for telbivudine

Country Patent Number Title Estimated Expiration
China 1714098 Crystalline and amorphous forms of beta-l-2'-deoxythymidine See Plans and Pricing
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) See Plans and Pricing
South Korea 20050083619 CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE See Plans and Pricing
Australia 2003265396 CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for telbivudine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1104436 07C0046 France See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: TELBIVUDINE
1104436 SPC/GB07/058 United Kingdom See Plans and Pricing 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.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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