Question 1

Is there a generic for Dolutegravir sodium; rilpivirine hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Dolutegravir sodium; rilpivirine hydrochloride. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Dolutegravir sodium; rilpivirine hydrochloride?

Accepted Answer

JULUCA (NDA 210192, 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; rilpivirine hydrochloride?

Accepted Answer

The Orange Book lists 6 patents against Dolutegravir sodium; rilpivirine hydrochloride 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; rilpivirine hydrochloride are approved?

Accepted Answer

Dolutegravir sodium; rilpivirine hydrochloride is approved in the following dosage form: tablet.

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
10426780	Jan 24, 2031	in 4 yr 8 mo	SubstanceProductU-257
12011506	Sep 05, 2038	in 12 yr 5 mo	Product

Dolutegravir sodium; rilpivirine hydrochloride

Brand (NDA) products · tablet

Listed patents (6)

Dolutegravir sodium; rilpivirine hydrochloride — frequently asked questions

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