ZONISAMIDE | N214273 | AZURITY PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Azurity Pharmaceuticals, Inc. v. Aurobindo Pharma Limited 3 patentsANDA 221557Zonisamide | D. Del. | 2026-07-01 | Active | — |
| D. Del. | 2025-05-07 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2023-P-4286 · 7 docket documents Newcastle Bioscience LLC filed this citizen petition on October 1, 2023 requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application (ANDA), based on the reference listed drug Zonegr | Suitability | 2023-10-03 | Denied | Newcastle Bioscience LLC |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0131 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Zonisamide Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an ANDA, representing a change in dosage form from | Other | 2018-01-11 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0130 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Zonisamide Tablets in strengths of 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg suitable for submission as an abbreviated new drug application, representing a change in dosage form from ca | Other | 2018-01-09 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0098 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zonisamide Capsules USP in 150 mg, 200 mg, and 300 mg strengths suitable for submission as an ANDA, with Zonegran | Other | 2018-01-09 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.75
per ml
Lowest NADAC/Unit
$2.75
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 52652800101ZONISADE 100 MG/5 ML ORAL SUSP | $2.75 | ML | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.