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Last Updated: October 31, 2024

TYZEKA Drug Patent Profile


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When do Tyzeka patents expire, and what generic alternatives are available?

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.

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Summary for TYZEKA
Drug patent expirations by year for TYZEKA
Recent Clinical Trials for TYZEKA

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

Supplementary Protection Certificates for TYZEKA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1104436 FR07C0046 France ⤷  Sign Up
1104436 2007/027 Ireland ⤷  Sign Up PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
1104436 CA 2007 00038 Denmark ⤷  Sign Up PRODUCT NAME: TELBIVUDINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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