Tivicay PD - (5 mg tablet for suspension)

Generic Name	Dolutegravir Sodium	Innovator	VIIV Healthcare
Dosage	5 mg tablet for suspension	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events