Question 1

Is there a generic for Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate?

Accepted Answer

SYMTUZA (NDA 210455, JANSSEN PRODS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate?

Accepted Answer

The Orange Book lists 6 patents against Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate products, with the earliest listed expiry in 2026. 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 Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate are approved?

Accepted Answer

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7700645	Dec 26, 2026	in 6 mo	SubstanceProduct
8148374	Sep 03, 2029	in 3 yr 3 mo	SubstanceProductU-2353
8754065	Aug 15, 2032	in 6 yr 3 mo	SubstanceProductU-2352
9296769	Aug 15, 2032	in 6 yr 3 mo	SubstanceProductU-2352
10039718	Oct 06, 2032	in 6 yr 5 mo	Product
10786518	Jul 19, 2038	in 12 yr 3 mo	U-2978

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate

Brand (NDA) products · tablet

Listed patents (6)

Cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate — frequently asked questions

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