LIDOCAINE | N020612 | TEIKOKU PHARMA USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Endo Pharmaceuticals Inc. et al v. TWi Pharmaceuticals Inc. et al 3 patentsANDA 203128lidocaine 5% | D. Del. | 2012-07-05 | Terminated 2014-04-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc FDA-2017-P-2528 · 15 docket documents Apotex Inc filed this citizen petition requesting that the FDA withdraw approval of the NDA for Lidoderm (lidocaine patch 5%) and deny any applications for lidocaine patches with similar formulations due to patent issues and concerns regarding the appropriateness of the original approval decision. | Other | 2017-04-21 | Open | Apotex Inc |
Endo Pharmaceuticals Inc - Citizen Petition FDA-2006-P-0346 · 15 docket documents Endo Pharmaceuticals Inc. filed this citizen petition on December 18, 2006, requesting that the FDA apply comparative clinical efficacy trial requirements under 21 C.F.R. § 320.24(b)(4) to any abbreviated new drug application seeking approval of a generic version of Lidoderm (lidocaine topical patch | 505(q) | 2008-11-17 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.01
per ea
Lowest NADAC/Unit
$2.01
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00603188016LIDOCAINE 5% PATCH | $2.01 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.