LACOSAMIDE | N022255 | UCB INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| 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 | — |
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. |
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. |
Suitability Petition from Sunshine Lake Pharma Co., Ltd. FDA-2019-P-0915 Sunshine Lake Pharma Co., Ltd. submitted a suitability petition under 21 CFR 314.93 and section 505(j)(2)(c) requesting FDA approval to file an abbreviated new drug application (ANDA) for Lacosamide Granules for Oral Solution 10 mg/mL, a new dosage form of the reference listed drug VIMPAT® Oral Solu | Suitability | 2019-02-26 | Open | Sunshine Lake Pharma Co., Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.30
per ml
Lowest NADAC/Unit
$2.30
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00131541072VIMPAT 10 MG/ML SOLUTION | $2.30 | ML | Brand | $0.0831 | 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 |