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Last Updated: August 14, 2022

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. There are two patents protecting this drug.

This drug has eleven patent family members in seven countries.

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.

DrugPatentWatch® Generic Entry Outlook for Tyzeka

Tyzeka was eligible for patent challenges on October 25, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 11, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TYZEKA
Drug patent expirations by year for TYZEKA
DrugPatentWatch® Estimated Generic Entry Opportunity Date for TYZEKA
Generic Entry Dates for TYZEKA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for TYZEKA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

TYZEKA is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TYZEKA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TYZEKA

Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS

Crystalline and amorphous forms of beta-L-2'-deoxythymidine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS

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 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
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 TYZEKA

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
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
>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
Russian Federation 2006147216 See Plans and Pricing
Hong Kong 1111913 See Plans and Pricing
Mexico PA01001507 °L-2'DESOXI-NUCLEOSIDOS PARA EL TRATAMIENTO DE HEPATITIS B. (beta-L-2'-DEOXY-NUCLEOSIDES FOR THE TREATMENT OF HEPATITIS B.) See Plans and Pricing
Germany 122007000062 See Plans and Pricing
South Korea 20060035817 See Plans and Pricing
Australia 5475799 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TYZEKA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1104436 91348 Luxembourg See Plans and Pricing CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
1104436 SZ 39/2007 Austria See Plans and Pricing PRODUCT NAME: TELBIVUDIN
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 2007/027 Ireland See Plans and Pricing PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.