FDA Orange Book · active-ingredient family
Atomoxetine hydrochloride
Atomoxetine hydrochloride 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:ATONCY · NDA 220320
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATONCYRLD | MAP77 | NDA 220320 | — | Mar 20, 2026 | |
| STRATTERARLD×8 | LILLY | NDA 021411 | — | Nov 26, 2002 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATOMOXETINE HYDROCHLORIDE×7 | ZYDUS PHARMS USA INC | ANDA 079017 | AB | Apr 05, 2023 | |
| ATOMOXETINE HYDROCHLORIDE×7 | HETERO LABS LTD V | ANDA 202682 | AB | Mar 11, 2021 | |
| ATOMOXETINE HYDROCHLORIDE×7 | STRIDES PHARMA | ANDA 079021 | AB | Feb 18, 2021 | |
| ATOMOXETINE HYDROCHLORIDE×7 | DR REDDYS | ANDA 090609 | AB | Feb 23, 2018 | |
| ATOMOXETINE HYDROCHLORIDE×7 | APOTEX | ANDA 078983 | AB | May 30, 2017 | |
| ATOMOXETINE HYDROCHLORIDE×7 | AUROBINDO PHARMA | ANDA 079016 | AB | May 30, 2017 | |
| ATOMOXETINE HYDROCHLORIDE×7 | GLENMARK PHARMS LTD | ANDA 079019 | AB | May 30, 2017 | |
| ATOMOXETINE HYDROCHLORIDE×7 | TEVA PHARMS USA | ANDA 079022 | AB | May 30, 2017 |
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.
Atomoxetine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
