Details for New Drug Application (NDA): 211994
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NDA 211994 describes DOVATO, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DOVATO profile page.
The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.
The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.
Summary for 211994
| Tradename: | DOVATO |
| Applicant: | Viiv Hlthcare |
| Ingredient: | dolutegravir sodium; lamivudine |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211994
Generic Entry Date for 211994*:
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: 211994
Suppliers and Packaging for NDA: 211994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994 | NDA | ViiV Healthcare Company | 49702-246 | 49702-246-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-246-13) |
| DOVATO | dolutegravir sodium; lamivudine | TABLET;ORAL | 211994 | NDA | ViiV Healthcare Company | 49702-246 | 49702-246-61 | 14 TABLET, FILM COATED in 1 BOTTLE (49702-246-61) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE;300MG | ||||
| Approval Date: | Apr 8, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 6, 2023 | ||||||||
| Regulatory Exclusivity Use: | TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 24, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HIV INFECTION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 5, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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