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Serving 500+ biopharmaceutical companies globally:

Argus Health
US Department of Justice
Healthtrust
Moodys
Farmers Insurance
Chinese Patent Office
Cerilliant
Teva
QuintilesIMS
Deloitte

Generated: September 24, 2017

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 fifty-five patent family members in twenty-one countries.

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

Summary for Generic Name: telbivudine

Tradenames:1
Patents:7
Applicants:1
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list45
Clinical Trials: see list75
Patent Applications: see list1,512
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:telbivudine at DailyMed
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
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► 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
TABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► SubscribeYY ► 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
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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
7,323,451Crystalline and amorphous forms of beta-L-2'-deoxythymidine► Subscribe
9,290,533.beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B► 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
2,011,195,922► 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
European Patent Office2607370► Subscribe
European Patent Office1534727► Subscribe
Hong Kong1034083► Subscribe
China101120947► Subscribe
Russian Federation2006147216► Subscribe
European Patent Office2415776► Subscribe
South Korea100691737► Subscribe
World Intellectual Property Organization (WIPO)0009531► Subscribe
Spain2255295► Subscribe
Spain2531928► 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
/2007Austria► SubscribePRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
00286Netherlands► SubscribePRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
348Luxembourg► SubscribeCERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424
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
07/027Ireland► SubscribePRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
0286Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
07C0046France► 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.
1104436/01Switzerland► SubscribeFORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
2007 00038Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Chubb
Federal Trade Commission
Mallinckrodt
Chinese Patent Office
AstraZeneca
Deloitte
Daiichi Sankyo
Express Scripts
Citi

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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