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EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE

ANDA

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE | A208452 | MYLAN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COMPLERA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Janssen Pharmaceutica, N.V. et al v. Mylan Pharmaceuticals, Inc. et al 1:2015cv00152 3 patentsANDA 208452emtricitabine, rilpivirine, and tenofovir disoproxil fumarate	WVND	2015-09-02	Terminated 2017-07-06	—

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 18, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG;EQ 25MG BASE;300MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 20, 2025

No patent or exclusivity listings for this strength.