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TYZEKA Drug Profile

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Tyzeka is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug.

This drug has fifty-two patent family members in twenty 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.

Summary for Tradename: TYZEKA

Patents:7
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYes6,395,716► subscribe ► subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYes7,795,238► subscribe ► subscribe
Novartis
TYZEKA
telbivudine
TABLET;ORAL022011-001Oct 25, 2006RXYes6,569,837► 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
2,011,195,922► subscribe
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
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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
Russian Federation2006147216► subscribe
Australia2003265396► subscribe
Denmark2415776► 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
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
/2007Austria► subscribePRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424
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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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