Question 1

Is there a generic for Lamivudine; raltegravir potassium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Lamivudine; raltegravir potassium. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Lamivudine; raltegravir potassium?

Accepted Answer

DUTREBIS (NDA 206510, MERCK SHARP DOHME) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lamivudine; raltegravir potassium?

Accepted Answer

The Orange Book lists 2 patents against Lamivudine; raltegravir potassium products, with the earliest listed expiry in 2029. 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 Lamivudine; raltegravir potassium are approved?

Accepted Answer

Lamivudine; raltegravir potassium is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7754731	Mar 11, 2029	in 2 yr 9 mo	SubstanceProductU-1663
7754731*PED	Sep 11, 2029	in 3 yr 3 mo

Lamivudine; raltegravir potassium

Brand (NDA) products · tablet

Listed patents (2)

Lamivudine; raltegravir potassium — frequently asked questions

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