ATOMOXETINE HYDROCHLORIDE | N021411 | ELI LILLY AND CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2011-05-05 | Terminated 2012-03-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Athyna Pharma, LLC FDA-2026-P-2639 · 9 docket documents Athyna Pharma, LLC filed this citizen petition under FDC Act section 505(j)(2)(C) requesting FDA approval to submit an ANDA for Atomoxetine Hydrochloride Solution, 5 mg base/mL oral liquid, which differs in dosage form and strength from the reference listed drug Eli Lilly's Strattera Capsules (NDA 0 | Suitability | 2026-03-13 | Open | Athyna Pharma, LLC |
Citizen Petition from Rosemont Pharmaceuticals Holdings, Inc. FDA-2025-P-6868 · 7 docket documents Rosemont Pharmaceuticals Holdings, Inc. filed this citizen petition requesting that the FDA determine the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Company were not discontinued due to safety or efficacy reasons, as | 505(q) | 2025-12-09 | Granted | Rosemont Pharmaceuticals Holdings, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$14.75
per ea
Lowest NADAC/Unit
$12.57
per ea
Brand NDCs
7
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00002325030STRATTERA 80 MG CAPSULE | $14.75 | EA | Brand | $0.5489 | 2025-07-23 |
| 00002325130STRATTERA 100 MG CAPSULE | $14.72 | EA | Brand | $0.5341 | 2025-07-23 |
| 00002323930STRATTERA 60 MG CAPSULE | $13.66 | EA | Brand | $0.4969 | 2025-07-23 |
| 00002322930STRATTERA 40 MG CAPSULE | $13.65 | EA | Brand | $0.4769 | 2025-07-23 |
| 00002322730STRATTERA 10 MG CAPSULE | $12.66 | EA | Brand | $0.3514 | 2025-07-23 |
| 00002323830STRATTERA 18 MG CAPSULE | $12.64 | EA | Brand | $0.4670 | 2025-07-23 |
| 00002322830STRATTERA 25 MG CAPSULE | $12.57 | EA | Brand | $0.4050 | 2025-07-23 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.