FDA Orange Book · active-ingredient family
Efavirenz; lamivudine; tenofovir disoproxil fumarate
Efavirenz; lamivudine; tenofovir disoproxil fumarate is approved as 4 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE · NDA 022343
4
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATERLD | AUROBINDO PHARMA LTD | NDA 022343 | — | Aug 15, 2018 | |
| SYMFIRLD | MYLAN LABS LTD | NDA 022142 | AB | Mar 22, 2018 | |
| SYMFI LORLD | MYLAN | NDA 208255 | — | Feb 05, 2018 | |
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | MACLEODS PHARMS LTD | NDA 210649 | — | Mar 15, 2019 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | LAURUS | ANDA 213038 | — | May 14, 2020 | |
| EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | LAURUS | ANDA 212786 | AB | May 14, 2020 |
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.
Efavirenz; lamivudine; tenofovir disoproxil fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
