Question 1

Is there a generic for Dolutegravir sodium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Dolutegravir sodium. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Dolutegravir sodium?

Accepted Answer

TIVICAY PD (NDA 213983, VIIV HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Dolutegravir sodium?

Accepted Answer

The Orange Book lists 4 patents against Dolutegravir sodium products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Dolutegravir sodium are approved?

Accepted Answer

Dolutegravir sodium is approved in the following dosage forms: tablet, tablet, for suspension.

Product	Applicant	Application	TE	Approved
TIVICAY PDRLD	VIIV HLTHCARE	NDA 213983	—	Jun 12, 2020
TIVICAYRLD×3	VIIV HLTHCARE	NDA 204790	—	Jun 09, 2016

Patent	Expires	In	Type
8129385	Oct 05, 2027	in 1 yr 4 mo	SubstanceProduct
8129385*PED	Apr 05, 2028	in 1 yr 10 mo
9242986	Dec 08, 2029	in 3 yr 6 mo	SubstanceProduct
9242986*PED	Jun 08, 2030	in 4 yr

Dolutegravir sodium

Brand (NDA) products · tablet, tablet, for suspension

Listed patents (4)

Dolutegravir sodium — frequently asked questions

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