Is there a generic for Emtricitabine?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Emtricitabine, referencing the brand EMTRIVA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Emtricitabine?

EMTRIVA (NDA 021896, 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 are approved?

Emtricitabine is approved in the following dosage forms: capsule, solution.

FDA Orange Book · active-ingredient family

Emtricitabine

Emtricitabine is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EMTRIVA · NDA 021896

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, solution

Product	Applicant	Application	TE	Approved
EMTRIVARLD	GILEAD	NDA 021896	—	Sep 28, 2005
EMTRIVARLD	GILEAD	NDA 021500	AB	Jul 02, 2003

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
EMTRICITABINE	AUROBINDO PHARMA LTD	ANDA 079188	AB	Mar 15, 2023
EMTRICITABINE	CIPLA	ANDA 091168	AB	Jul 02, 2018

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 — frequently asked questions

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

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