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FDA Orange Book · active-ingredient family

Efavirenz; emtricitabine; tenofovir disoproxil fumarate

Efavirenz; emtricitabine; tenofovir disoproxil fumarate is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ATRIPLA · NDA 021937

1

Brand (NDA)

8

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ATRIPLARLDGILEAD SCIENCESNDA 021937—Jul 12, 2006

Generic (ANDA) products (8)

ProductApplicantApplicationTEApproved
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEMYLANANDA 209061—Sep 05, 2024
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATECHARTWELL RXANDA 201802—Oct 03, 2023
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEHETERO LABS LTD VANDA 203053ABJan 24, 2022
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATELAURUSANDA 213541ABDec 22, 2021
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEMACLEODS PHARMS LTDANDA 204287ABSep 13, 2021
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATECIPLAANDA 206894ABJun 03, 2019
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATETEVA PHARMS USAANDA 091215ABNov 09, 2018
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEAUROBINDO PHARMAANDA 203041ABSep 04, 2018

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9018192Jun 13, 20266 d ago
U-750
9545414Jun 13, 20266 d ago
ProductU-1170
8598185Apr 28, 2029in 2 yr 11 mo
Product

Efavirenz; 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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