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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Teva
QuintilesIMS
US Army
Chinese Patent Office
Dow
Moodys
Argus Health
AstraZeneca

Generated: November 23, 2017

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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 and twelve supplementary protection certificates in nine countries.

There are two drug master file entries for telbivudine. One supplier is listed for this compound.
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;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
SOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
SOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
SOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
SOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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► Subscribe
9,290,533.beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B► Subscribe
7,323,451Crystalline and amorphous forms of beta-L-2'-deoxythymidine► Subscribe
7,304,043.beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B► Subscribe
6,946,450 .beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: telbivudine

Country Document Number Estimated Expiration
China100376593► Subscribe
South Korea20060035817► Subscribe
Hong Kong1111913► Subscribe
South Korea20060038483► Subscribe
European Patent Office1431304► Subscribe
South Korea20080032260► Subscribe
Australia2003265396► Subscribe
South Korea20050083619► Subscribe
Cyprus1116988► Subscribe
BrazilPI9912896► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TELBIVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
07C0046France► Subscribe
C0046France► SubscribePRODUCT 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
7Finland► Subscribe
C/GB07/058United Kingdom► SubscribeSUPPLEMENTARY 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.
348Luxembourg► SubscribeCERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
07/027Ireland► SubscribePRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
/2007Austria► SubscribePRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
0286Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
2007 00038Denmark► Subscribe
39/2007Austria► SubscribePRODUCT NAME: TELBIVUDIN
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Daiichi Sankyo
US Department of Justice
Deloitte
Queensland Health
McKesson
Citi
Chinese Patent Office
Argus Health
Cipla

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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