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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Mallinckrodt
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Healthtrust
UBS
Accenture
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Generated: December 18, 2017

DrugPatentWatch Database Preview

TYZEKA Drug Profile

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Which patents cover Tyzeka, and what generic alternatives are available?

Tyzeka is a drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this drug.

This drug has sixty patent family members in twenty-one countries and twelve supplementary protection certificates in nine countries.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the telbivudine profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► SubscribeYY► Subscribe
NovartisTYZEKAtelbivudineTABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► SubscribeYY► Subscribe
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineTABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineTABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineTABLET;ORAL022011-001Oct 25, 2006RXYesYes► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
NovartisTYZEKAtelbivudineSOLUTION;ORAL022154-001Apr 28, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: TYZEKA

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
2,011,195,922► 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
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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 Tradename: TYZEKA

Country Document Number Estimated Expiration
Japan4294870► Subscribe
Hong Kong1034083► Subscribe
Cyprus1116988► Subscribe
Germany122007000062► Subscribe
South Korea20060035817► Subscribe
European Patent Office1534727► Subscribe
China101120947► Subscribe
MexicoPA01001507► Subscribe
Russian Federation2006147216► Subscribe
South Korea20080032260► 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: TYZEKA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2007Austria► SubscribePRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
0286Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT
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
07C0046France► Subscribe
07/027Ireland► SubscribePRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 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
39/2007Austria► SubscribePRODUCT NAME: TELBIVUDIN
1104436/01Switzerland► SubscribeFORMER OWNER: CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE, FR
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Serving leading biopharmaceutical companies globally:

Novartis
Argus Health
Express Scripts
Deloitte
Chinese Patent Office
Merck
Moodys
Medtronic
Accenture
Fish and Richardson

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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