Question 1

Is there a generic for Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate, referencing the brand ODEFSEY. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate?

Accepted Answer

ODEFSEY (NDA 208351, GILEAD SCIENCES INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate?

Accepted Answer

The Orange Book lists 4 patents against Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide 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 Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate are approved?

Accepted Answer

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9296769	Aug 15, 2032	in 6 yr 3 mo	SubstanceProductU-257
8754065	Aug 15, 2032	in 6 yr 3 mo	SubstanceProductU-257
8754065*PED	Feb 15, 2033	in 6 yr 9 mo
9296769*PED	Feb 15, 2033	in 6 yr 9 mo

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Listed patents (4)

Emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate — frequently asked questions

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