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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 208452


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NDA 208452 describes EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE profile page.

The generic ingredient in EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.
Summary for 208452
Tradename:EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
Applicant:Mylan
Ingredient:emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patents:0
Pharmacology for NDA: 208452
Mechanism of ActionNon-Nucleoside Reverse Transcriptase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Suppliers and Packaging for NDA: 208452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 208452 ANDA Mylan Pharmaceuticals Inc. 0378-5440 0378-5440-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5440-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;300MG
Approval Date:May 20, 2025TE:ABRLD:No
Regulatory Exclusivity Expiration:Nov 23, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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