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Serving leading biopharmaceutical companies globally:

Cipla
Daiichi Sankyo
Healthtrust
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Baxter
Fish and Richardson
Chinese Patent Office
Citi
Dow
Novartis

Generated: December 14, 2017

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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the telbivudine profile page.

Summary for 022011

Tradename:1
Applicant:1
Ingredient:1
Patents:7
Formulation / Manufacturing:see details

Pharmacology for NDA: 022011

Suppliers and Packaging for NDA: 022011

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYZEKA telbivudine TABLET;ORAL 022011 NDA Novartis Pharmaceuticals Corporation 0078-0538 0078-0538-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0538-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Oct 25, 2006TE:RLD:Yes
Patent:► SubscribePatent 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:► SubscribePatent 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:► SubscribePatent 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 leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Fuji
McKesson
Covington
Moodys
Queensland Health
US Department of Justice
Citi
UBS

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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