FDA Orange Book · active-ingredient family
Atazanavir sulfate
Atazanavir sulfate is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:REYATAZ · NDA 206352
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| REYATAZRLD | BRISTOL MYERS SQUIBB | NDA 206352 | — | Jun 02, 2014 | |
| REYATAZRLD×4 | BRISTOL MYERS SQUIBB | NDA 021567 | — | Jun 20, 2003 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATAZANAVIR SULFATE×3 | HETERO LABS LTD III | ANDA 212278 | AB | Feb 02, 2022 | |
| ATAZANAVIR SULFATE×3 | LAURUS | ANDA 212579 | AB | Apr 30, 2021 | |
| ATAZANAVIR SULFATE×3 | ZYDUS PHARMS | ANDA 210575 | — | Jun 04, 2020 | |
| ATAZANAVIR SULFATE×4 | AMNEAL | ANDA 209717 | — | Jun 01, 2020 | |
| ATAZANAVIR SULFATE×3 | MYLAN | ANDA 208177 | — | Sep 24, 2018 | |
| ATAZANAVIR SULFATE×4 | CIPLA | ANDA 200626 | — | Aug 09, 2018 | |
| ATAZANAVIR SULFATE×4 | AUROBINDO PHARMA | ANDA 204806 | AB | Jun 25, 2018 | |
| ATAZANAVIR SULFATE×4 | TEVA PHARMS USA | ANDA 091673 | AB | Apr 22, 2014 |
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.
Atazanavir sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
