LAMOTRIGINE | N022115 | GLAXOSMITHKLINE LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-09-28 | Terminated 2018-11-27 | — | |
| D. Del. | 2018-04-12 | Terminated 2018-05-01 | — | |
Glaxo Group Ltd. et al v. Aurobindo Pharma USA, Inc. et al 2 patentsANDA 211054Lamotrigine | D. Del. | 2017-12-27 | Terminated 2018-02-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Actavis Elizabeth LLC - Citizen Petition FDA-2010-P-0658 · 3 docket documents Actavis Elizabeth LLC filed this citizen petition on December 29, 2010, requesting that the FDA determine that LAMICTAL (lamotrigine) Extended-Release Tablets, 300 mg, approved under NDA 22-115, were not voluntarily withdrawn for safety or efficacy reasons, citing that the product was never commerci | 505(q) | 2011-01-14 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$48.70
per ea
Lowest NADAC/Unit
$14.15
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00173076100LAMICTAL XR 300 MG TABLET | $48.70 | EA | Brand | $1.21 | 2026-06-17 |
| 00173078100LAMICTAL XR 250 MG TABLET | $44.31 | EA | Brand | $1.30 | 2026-06-17 |
| 00173075700LAMICTAL XR 200 MG TABLET | $32.34 | EA | Brand | $0.7627 | 2026-06-17 |
| 00173075600LAMICTAL XR 100 MG TABLET | $30.42 | EA | Brand | $0.6790 | 2026-06-17 |
| 00173075500LAMICTAL XR 50 MG TABLET | $28.18 | EA | Brand | $0.5450 | 2026-06-17 |
| 00173075400LAMICTAL XR 25 MG TABLET | $14.15 | EA | Brand | $0.2994 | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8637512 | Jan 7, 2029 | — | — | Yes | — | — |