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Last Updated: August 9, 2022

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.
Summary for 211994
Tradename:DOVATO
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium; lamivudine
Patents:3
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

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:RXDosage:TABLET;ORALStrengthEQ 50MG BASE;300MG
Approval Date:Apr 8, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 8, 2022
Regulatory Exclusivity Use:NEW COMBINATION
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:See Plans and PricingPatent Expiration:Jan 24, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HIV INFECTION

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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 verification 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.