DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204790
NDA 204790 describes TIVICAY, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
The generic ingredient in TIVICAY is dolutegravir sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolutegravir sodium profile page.
Summary for 204790
| Tradename: | TIVICAY |
| Applicant: | Viiv Hlthcare |
| Ingredient: | dolutegravir sodium |
| 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 | N | 49702-226-13 |
| TIVICAY | dolutegravir sodium | TABLET;ORAL | 204790 | NDA | ViiV Healthcare Company | 49702-227 | N | 49702-227-13 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Aug 12, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 21, 2020 | ||||||||
| Regulatory Exclusivity Use: | FOR USE WITH RILPIVIRINE AS A COMPLETE REGIMEN TO REPLACE THE CURRENT ARV REGIMEN IN VIROLOGICALLY SUPPRESSED PATIENTS ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TX FAILURE OR KNOWN SUBSTITUTIONS ASSOC. WITH RESISTANCE TO EITHER ARV | ||||||||
| 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 | ||||||||
Complete Access Available with Subscription
