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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cerilliant
US Army
Fuji
Dow
Boehringer Ingelheim
Mallinckrodt
Farmers Insurance
Fish and Richardson

Generated: July 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022011

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NDA 022011 describes TYZEKA, which is a drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this drug. Additional details are available on the TYZEKA profile page.

The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. Additional details are available on the telbivudine profile page.
Summary for 022011
Tradename:TYZEKA
Applicant:Novartis
Ingredient:telbivudine
Patents:7
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022011
Generic Entry Date for 022011*:
Constraining patent/regulatory exclusivity:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength600MG
Approval Date:Oct 25, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Aug 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
Patent:➤ Sign UpPatent Expiration:Aug 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
Patent:➤ Sign UpPatent Expiration:Aug 10, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
QuintilesIMS
Queensland Health
Merck
UBS
Federal Trade Commission
Moodys
Colorcon
Julphar

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.