You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

TELBIVUDINE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries 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 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 TELBIVUDINE

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
>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

Make Better Decisions: Try a trial or see plans & pricing

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.