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Details for New Drug Application (NDA): 204790
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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 and one Paragraph IV challenge. Additional details are available on the TIVICAY profile page.
The generic ingredient in TIVICAY is dolutegravir sodium. There are seventeen drug master file entries for this compound. Three 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 seventeen 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 204790
| Tradename: | TIVICAY |
| Applicant: | Viiv Hlthcare |
| Ingredient: | dolutegravir sodium |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 204790
Generic Entry Date for 204790*:
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.
Pharmacology for NDA: 204790
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) |
Paragraph IV (Patent) Challenges for 204790
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TIVICAY | TABLET;ORAL | dolutegravir sodium | 204790 | 2017-08-14 |
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 | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 5, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Dec 8, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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