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Serving leading biopharmaceutical companies globally:

Julphar
Healthtrust
Accenture
Baxter
McKesson
Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
Citi
Medtronic

Generated: February 24, 2018

DrugPatentWatch Database Preview

Telbivudine - Generic Drug Details

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What are the generic sources for telbivudine and what is the scope of telbivudine patent protection?

Telbivudine
is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telbivudine has sixty patent family members in twenty-one countries.

There are two drug master file entries for telbivudine. One supplier is listed for this compound.

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis TYZEKA telbivudine TABLET;ORAL 022011-001 Oct 25, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novartis TYZEKA telbivudine SOLUTION;ORAL 022154-001 Apr 28, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for telbivudine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,011,195,922 ➤ Try a Free Trial
9,290,533 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Try a Free Trial
6,946,450 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Try a Free Trial
7,323,451 Crystalline and amorphous forms of beta-L-2'-deoxythymidine ➤ Try a Free Trial
7,304,043 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for telbivudine

Supplementary Protection Certificates for telbivudine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2007 Austria ➤ Try a Free Trial PRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
C/GB07/058 United Kingdom ➤ Try a Free 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.
7 Finland ➤ Try a Free Trial
348 Luxembourg ➤ Try a Free Trial CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
00286 Netherlands ➤ Try a Free Trial PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
39/2007 Austria ➤ Try a Free Trial PRODUCT NAME: TELBIVUDIN
1104436/01 Switzerland ➤ Try a Free Trial FORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
07/027 Ireland ➤ Try a Free Trial PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
C0046 France ➤ Try a Free 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
2007 00038 Denmark ➤ Try a Free Trial PRODUCT NAME: TELBIVUDINE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Healthtrust
Argus Health
McKesson
Fish and Richardson
Moodys
Chubb
Baxter
Queensland Health

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 verifification 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.

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