TOPIRAMATE | N205122 | UPSHER SMITH LABORATORIES LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Upsher-Smith Laboratories, LLC v. Xiamen LP Pharmaceutical Co., Ltd. 4 patentsANDA 215638topiramate | D. Del. | 2023-02-23 | Terminated 2024-07-29 | — |
| D. Del. | 2017-05-26 | Terminated 2018-04-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman Phelps & McNamara, P.C. (Upsher-Smith Laboratorie... FDA-2016-P-4141 · 4 docket documents Hyman, Phelps & McNamara, P.C., on behalf of Upsher-Smith Laboratories, Inc., requested that the FDA assign a therapeutic equivalence evaluation code of BC to Upsher-Smith's QUDEXY XR (topiramate) extended-release capsules in four strengths (25, 50, 100, and 200 mg) approved under NDA 205122 pursuan | Other | 2016-12-01 | Partially Denied | Hyman Phelps & McNamara, P.C. (Upsher-Smith Laboratories, Inc.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.23
per ea
Lowest NADAC/Unit
$2.66
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00832107330TOPIRAMATE ER 200 MG SPRINK CAP | $11.23 | EA | Generic | — | 2026-06-17 |
| 00832107530TOPIRAMATE ER 150 MG SPRINK CAP | $8.83 | EA | Generic | — | 2026-06-17 |
| 00832107430TOPIRAMATE ER 100 MG SPRINK CAP | $5.60 | EA | Generic | — | 2026-06-17 |
| 00832107230TOPIRAMATE ER 50 MG SPRINKL CAP | $3.66 | EA | Generic | — | 2026-06-17 |
| 00832107130TOPIRAMATE ER 25 MG SPRINKL CAP | $2.66 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.