Question 1

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

Accepted Answer

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate, referencing the brand COMPLERA. 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 disoproxil fumarate?

Accepted Answer

COMPLERA (NDA 202123, 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 disoproxil fumarate?

Accepted Answer

The Orange Book lists 1 patent against Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate products, with the earliest listed expiry in 2033. 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 disoproxil fumarate are approved?

Accepted Answer

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

Product	Applicant	Application	TE	Approved
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	LAURUS	ANDA 220232	AB	Mar 04, 2026
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE	MYLAN	ANDA 208452	AB	May 20, 2025

Emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate

Brand (NDA) products · tablet

Generic (ANDA) products (2)

Listed patents (1)

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

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