FDA Orange Book · active-ingredient family
Efavirenz
Efavirenz is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SUSTIVA · NDA 021360
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUSTIVARLD×2 | BRISTOL MYERS SQUIBB | NDA 021360 | — | Feb 01, 2002 | |
| SUSTIVARLD×3 | BRISTOL MYERS SQUIBB | NDA 020972 | — | Sep 17, 1998 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EFAVIRENZ | MACLEODS PHARMS LTD | ANDA 091579 | AB | May 10, 2024 | |
| EFAVIRENZ | STRIDES PHARMA | ANDA 078509 | — | Jun 16, 2021 | |
| EFAVIRENZ | AUROBINDO PHARMA LTD | ANDA 077673 | AB | Sep 21, 2018 | |
| EFAVIRENZ | AUROBINDO PHARMA | ANDA 205322 | — | Aug 30, 2018 | |
| EFAVIRENZ | CIPLA | ANDA 204766 | AB | Jun 15, 2018 | |
| EFAVIRENZ | HETERO LABS LTD III | ANDA 078886 | AB | Apr 27, 2018 | |
| EFAVIRENZ | PHARMOBEDIENT | ANDA 204869 | AB | Mar 12, 2018 | |
| EFAVIRENZ×3 | AUROBINDO PHARMA | ANDA 078064 | — | Dec 15, 2017 | |
| EFAVIRENZ | MYLAN | ANDA 091471 | — | Feb 17, 2016 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
