AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | N022063 | TAKEDA PHARMACEUTICALS USA INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2018-00290 | 8846100 | IPR | KVK-Tech, Inc. et al. | Final Written Decision | 2017-12-11 | — |
| IPR2017-00665 | 8846100 | IPR | Amerigen Pharmaceuticals Limited | Terminated-Settled | 2017-01-13 | — |
| IPR2018-00293 | 9173857 | IPR | KVK-Tech, Inc. et al. | Final Written Decision | 2017-12-11 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-07-07 | Terminated 2023-07-27 | — | |
| D. Del. | 2018-05-25 | Terminated 2019-01-29 | — | |
| D. Del. | 2018-04-13 | Terminated 2019-10-09 | — | |
Shire Development LLC et al v. Teva Pharmaceuticals USA, Inc. et al 3 patentsANDA 210876Mixed salts of a single-entity amphetamine | D. Del. | 2017-11-22 | Terminated 2019-11-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Shire Development LLC FDA-2017-P-6851 · 9 docket documents Shire Development LLC submitted this citizen petition on December 20, 2017, requesting that the FDA require additional specific bioequivalence parameters for any abbreviated new drug application (ANDA) referencing Mydayis (mixed salts of a single-entity amphetamine product, extended-release capsules | 505(q) | 2017-12-20 | Partially Denied | Shire Development LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$10.82
per ea
Lowest NADAC/Unit
$10.75
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 54092047701MYDAYIS ER 50 MG CAPSULE | $10.82 | EA | Brand | $8.18 | 2026-06-17 |
| 54092047101MYDAYIS ER 25 MG CAPSULE | $10.81 | EA | Brand | $8.19 | 2026-06-17 |
| 54092046801MYDAYIS ER 12.5 MG CAPSULE | $10.76 | EA | Brand | $8.09 | 2026-06-17 |
| 54092047401MYDAYIS ER 37.5 MG CAPSULE | $10.75 | EA | Brand | $8.26 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.