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Last Updated: March 28, 2024

tyzeka Drug Patent Profile


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When do Tyzeka patents expire, and when can generic versions of Tyzeka launch?

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.

Drug patent expirations by year for tyzeka
Recent Clinical Trials for tyzeka

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

SponsorPhase
Chinese University of Hong KongN/A
NovartisPhase 4
Novartis PharmaceuticalsPhase 3

See all tyzeka clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 tyzeka

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

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

International Patents for tyzeka

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

Country Patent Number Title Estimated Expiration
European Patent Office 1104436 BETA-L-2'-DESOXY-NUCLEOSIDES POUR LE TRAITEMENT DE L'HEPATITE B (BETA-L-2'-DEOXY-NUCLEOSIDES FOR THE TREATMENT OF HEPATITIS B VIRUS) ⤷  Try a Trial
Portugal 1431304 ⤷  Try a Trial
European Patent Office 1431304 Beta-L-2'-deoxy-nucléosides pour le traitement de l'hépatite B (Beta - L-2'-Deoxy-Nucleosides for the treatment of Hepatitis B) ⤷  Try a Trial
Germany 122007000062 ⤷  Try a Trial
Denmark 1104436 ⤷  Try a Trial
Luxembourg 91348 ⤷  Try a Trial
China 1714098 Crystalline and amorphous forms of beta-l-2'-deoxythymidine ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tyzeka

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1104436 SPC/GB07/058 United Kingdom ⤷  Try a Trial 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.
1104436 300286 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1104436 91348 Luxembourg ⤷  Try a Trial CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
1104436 C01104436/01 Switzerland ⤷  Try a Trial FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
1104436 C300286 Netherlands ⤷  Try a Trial PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
1104436 SZ 39/2007 Austria ⤷  Try a Trial PRODUCT NAME: TELBIVUDIN
1104436 07C0046 France ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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