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Generated: September 22, 2018

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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:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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:

Teva
Cerilliant
AstraZeneca
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Colorcon
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Johnson and Johnson

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