METHYLPHENIDATE HYDROCHLORIDE | N202100 | NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Tris Pharma Inc. v. Par Pharmaceutical Inc. et al 5 patentsANDA 206926methylphenidate hydrochloride (methylphenidate HCl) | D. Del. | 2015-01-21 | Terminated 2015-11-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer, Inc. FDA-2014-P-1269 · 3 docket documents Pfizer, Inc. filed this petition requesting that the FDA establish partial AUC metrics, specifically AUC (0-3) and AUC (3-t) in both fasted and fed states, as the appropriate bioequivalence standards for any ANDA product proposing to demonstrate therapeutic equivalence to Quillivant XR, a modified-r | 505(q) | 2014-08-28 | Partially Denied | Pfizer, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.40
per ml
Lowest NADAC/Unit
$1.80
per ml
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 24478032102QUILLIVANT XR 25 MG/5 ML SUSP | $5.40 | ML | Brand | — | 2026-06-17 |
| 24478032204QUILLIVANT XR 25 MG/5 ML SUSP | $2.70 | ML | Brand | — | 2026-06-17 |
| 24478032305QUILLIVANT XR 25 MG/5 ML SUSP | $2.16 | ML | Brand | — | 2026-06-17 |
| 24478032406QUILLIVANT XR 25 MG/5 ML SUSP | $1.80 | ML | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.