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EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE

ANDA

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE | A214095 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ODEFSEY(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Gilead Sciences, Inc. v. Apotex, Inc. et al 1:2020cv00189 4 patentsANDA 213867, 214053, 214095, 214226, 213926, 214227, 214030, 213989, 214072, 213845, 214173, 214059, 214058, 214216, 214179, 211850tenofovir alafenamide	D. Del.	2020-02-07	Terminated 2022-09-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 3, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG;EQ 25MG BASE;EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 30, 2026

No patent or exclusivity listings for this strength.