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Last Updated: July 14, 2020

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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 two 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
Applicant:Viiv Hlthcare
Ingredient:dolutegravir sodium; lamivudine
Generic Entry Opportunity Date for 211994
Generic Entry Date for 211994*:
Constraining patent/regulatory exclusivity:

*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)
Paragraph IV (Patent) Challenges for 211994
Tradename Dosage Ingredient NDA Submissiondate
DOVATO TABLET;ORAL dolutegravir sodium; lamivudine 211994 2019-07-30

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
Patent:  Start TrialPatent Expiration:Oct 5, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 8, 2029Product Flag?YSubstance Flag?YDelist Request?

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