Assyro AI

FDA Orange Book · active-ingredient family

Tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VIREAD · NDA 022577

2

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder, tablet

ProductApplicantApplicationTEApproved
VIREADRLDGILEAD SCIENCES INCNDA 022577—Jan 18, 2012
VIREADRLD×4GILEAD SCIENCES INCNDA 021356ABJan 18, 2012

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
TENOFOVIR DISOPROXIL FUMARATEMICRO LABSANDA 206157ABDec 18, 2025
TENOFOVIR DISOPROXIL FUMARATEPHARMOBEDIENTANDA 079071ABFeb 29, 2024
TENOFOVIR DISOPROXIL FUMARATEREYOUNGANDA 211337ABMar 02, 2023
TENOFOVIR DISOPROXIL FUMARATE×4PHARMOBEDIENTANDA 206569—Nov 27, 2018
TENOFOVIR DISOPROXIL FUMARATECHARTWELLANDA 206481ABJul 26, 2018
TENOFOVIR DISOPROXIL FUMARATE×3QILUANDA 209498ABMar 02, 2018
TENOFOVIR DISOPROXIL FUMARATECHARTWELL RXANDA 209550—Feb 26, 2018
TENOFOVIR DISOPROXIL FUMARATE×4AUROBINDO PHARMAANDA 090647ABJan 26, 2018
TENOFOVIR DISOPROXIL FUMARATECIPLAANDA 078800ABJan 26, 2018
TENOFOVIR DISOPROXIL FUMARATEHETERO LABS LTD IIIANDA 090636ABJan 26, 2018
TENOFOVIR DISOPROXIL FUMARATEMACLEODS PHARMS LTDANDA 203232ABJan 26, 2018
TENOFOVIR DISOPROXIL FUMARATESTRIDES PHARMAANDA 090742ABJan 26, 2018
TENOFOVIR DISOPROXIL FUMARATE×4TEVA PHARMS USAANDA 091612ABJan 26, 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.

Tenofovir disoproxil fumarate — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo