LACOSAMIDE | N022253 | UCB INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| KYED | 2021-02-05 | Terminated 2021-12-16 | — | |
| D. Del. | 2016-06-17 | Terminated 2018-09-20 | — | |
| N.D. Ill. | 2013-08-01 | Terminated 2013-09-16 | — | |
UCB Inc. et al v. Watson Laboratories Inc. - Florida et al 1 patentANDA 204855lacosamide | D. Del. | 2013-07-10 | Terminated 2016-09-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nicholas J. Gardino FDA-2024-P-4164 Nicholas J. Gardino, an individual citizen and parent of a child with epilepsy, filed this petition to the DEA and FDA under Section 201 of the Controlled Substances Act and relevant CFR regulations, requesting that lacosamide be decontrolled from its current Schedule V classification. Gardino argue | Other | 2024-09-03 | Denied | Nicholas J. Gardino |
Suitability Petition Amendment from Newcastle Bioscience LLC FDA-2024-P-3293 Newcastle Bioscience LLC filed an amendment to its suitability petition for Lacosamide ODT, correcting the requested strength from 125 mg to 112.5 mg to align with the proposed labeling for consideration as suitable for ANDA filing. The amendment addresses an administrative error identified in the o | Suitability | 2024-08-01 | Granted | — |
Suitability Petition from Newcastle Bioscience LLC FDA-2024-P-3293 Newcastle Bioscience LLC filed this petition under Section 505(j)(2)(C) requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 25 mg, 37.5 mg, 75 mg, 112.5 mg, and 175 mg suitable for submission as an ANDA, using Vimpat (lacosamide) Tablets 200 mg as the reference-l | Suitability | 2024-07-12 | Granted | Newcastle Bioscience LLC |
Suitability Citizen Petition from Newcastle Bioscience LLC FDA-2023-P-4291 Newcastle Bioscience LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg suitable for submission as an abbreviated new drug ap | Suitability | 2023-10-04 | Granted | Newcastle Bioscience LLC |
Attachment B Package Insert of Lacosamide Granules for Oral Solution re: Suit... FDA-2019-P-0915 Sunshine Lake Pharma Co., Ltd. filed a suitability petition regarding lacosamide granules for oral solution, requesting FDA evaluation of the proposed product formulation and manufacturing process to establish suitability for an abbreviated new drug application (ANDA) or comparable regulatory pathwa | Suitability | 2019-02-26 | Open | Sunshine Lake Pharma Co., Ltd. |
Attachment A Package Insert of Reference List Drug (Vimpat ®) re Suitability ... FDA-2019-P-0915 Sunshine Lake Pharma Co., Ltd. filed a suitability petition regarding Vimpat, requesting FDA review and confirmation that the company's proposed ANDA or generic drug product would be suitable for approval based on the reference listed drug's established safety and efficacy profile. | Suitability | 2019-02-26 | Open | Sunshine Lake Pharma Co., Ltd. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2017-P-4233 Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg suitable for submission | Other | 2017-07-14 | Granted | Lachman Consultant Services, Inc. |
UCB, Inc. - Citizen Petition FDA-2013-P-1397 UCB, Inc., submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine the new chemical entity exclusivity period for lacosamide, marketed as Vimpat, should begin on June 9, 2009 (when the drug could be legally marketed following con | 505(q) Stay Request | 2013-11-27 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$19.65
per ea
Lowest NADAC/Unit
$11.83
per ea
Brand NDCs
8
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00131247935VIMPAT 150 MG TABLET | $19.65 | EA | Brand | $0.2285 | 2026-10-21 |
| 00131247960VIMPAT 150 MG TABLET | $19.65 | EA | Brand | $0.2285 | 2026-10-21 |
| 00131248060VIMPAT 200 MG TABLET | $19.63 | EA | Brand | $0.2518 | 2026-10-21 |
| 00131248035VIMPAT 200 MG TABLET | $19.63 | EA | Brand | $0.2518 | 2026-10-21 |
| 00131247860VIMPAT 100 MG TABLET | $18.53 | EA | Brand | $0.1887 | 2026-10-21 |
| 00131247835VIMPAT 100 MG TABLET | $18.53 | EA | Brand | $0.1887 | 2026-10-21 |
| 00131247735VIMPAT 50 MG TABLET | $11.83 | EA | Brand | $0.1205 | 2026-10-21 |
| 00131247760VIMPAT 50 MG TABLET | $11.83 | EA | Brand | $0.1205 | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| D-188 | Apr 28, 2026 | Expired |