Question 1

Is there a generic for Doravirine; lamivudine; tenofovir disoproxil fumarate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Doravirine; lamivudine; tenofovir disoproxil fumarate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Doravirine; lamivudine; tenofovir disoproxil fumarate?

Accepted Answer

DELSTRIGO (NDA 210807, MSD MERCK CO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Doravirine; lamivudine; tenofovir disoproxil fumarate?

Accepted Answer

The Orange Book lists 3 patents against Doravirine; lamivudine; tenofovir disoproxil fumarate products, with the earliest listed expiry in 2032. 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 Doravirine; lamivudine; tenofovir disoproxil fumarate are approved?

Accepted Answer

Doravirine; lamivudine; tenofovir disoproxil fumarate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8486975	Aug 30, 2032	in 6 yr 3 mo	SubstanceProductU-2629
10603282	Nov 29, 2036	in 10 yr 7 mo	Product
10842751	Nov 29, 2036	in 10 yr 7 mo	Product

Doravirine; lamivudine; tenofovir disoproxil fumarate

Brand (NDA) products · tablet

Listed patents (3)

Doravirine; lamivudine; tenofovir disoproxil fumarate — frequently asked questions

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