Is there a generic for Emtricitabine; tenofovir disoproxil fumarate?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Emtricitabine; tenofovir disoproxil fumarate, referencing the brand TRUVADA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

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

TRUVADA (NDA 021752, GILEAD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Emtricitabine; tenofovir disoproxil fumarate are approved?

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

FDA Orange Book · active-ingredient family

Emtricitabine; tenofovir disoproxil fumarate

Emtricitabine; tenofovir disoproxil fumarate is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRUVADA · NDA 021752

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TRUVADARLD×4	GILEAD	NDA 021752	AB	Mar 10, 2016

Generic (ANDA) products (13)

Product	Applicant	Application	TE	Approved
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE×3	AUROBINDO PHARMA LTD	ANDA 211640	AB	Mar 09, 2023
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE×4	HETERO LABS LTD III	ANDA 201806	AB	Oct 07, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE×4	ZYDUS PHARMS	ANDA 212689	AB	Jul 01, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	APOTEX	ANDA 208740	—	Jun 16, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	CHARTWELL RX	ANDA 204131	AB	Jun 04, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	CIPLA	ANDA 090958	—	Apr 02, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	STRIDES PHARMA	ANDA 091055	AB	Jan 13, 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	MACLEODS PHARMS LTD	ANDA 203442	AB	May 15, 2020
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	LAURUS	ANDA 212114	AB	Jul 26, 2019
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE×4	AMNEAL PHARMS CO	ANDA 209721	AB	Aug 22, 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	PHARMOBEDIENT	ANDA 206436	AB	Apr 09, 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	AUROBINDO PHARMA	ANDA 090513	AB	Jan 26, 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	TEVA PHARMS USA	ANDA 090894	AB	Jun 08, 2017

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Emtricitabine; tenofovir disoproxil fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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