Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
QuintilesIMS
US Army
Accenture
Colorcon
Daiichi Sankyo
Chinese Patent Office
McKesson
Merck

Generated: October 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204790

« Back to Dashboard
NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the TIVICAY profile page.

The generic ingredient in TIVICAY is dolutegravir sodium. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.

Summary for NDA: 204790

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVICAY
dolutegravir sodium
TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-226 49702-226-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-226-13)
TIVICAY
dolutegravir sodium
TABLET;ORAL 204790 NDA ViiV Healthcare Company 49702-227 49702-227-13 30 TABLET, FILM COATED in 1 BOTTLE (49702-227-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Aug 12, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 12, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jul 30, 2018
Regulatory Exclusivity Use:UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS
Patent:► SubscribePatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Fuji
Chubb
McKinsey
Merck
Cerilliant
US Department of Justice
Farmers Insurance
Moodys
Healthtrust

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot