TASIMELTEON | A211654 | MSN LABORATORIES PRIVATE LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al 1 patentANDA 211654tasimelteon | D. Del. | 2020-03-03 | Terminated 2022-01-19 | — |
Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al 7 patentsANDA 211654tasimelteon | D. Del. | 2018-05-07 | Terminated 2022-01-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from McDermott Will & Emery LLP FDA-2023-P-1985 · 15 docket documents McDermott Will & Emery LLP, on behalf of Vanda Pharmaceuticals Inc., filed this citizen petition requesting that FDA revoke approval of ANDA No. 211654 submitted by MSN Pharmaceuticals Inc. for 20 mg tasimelteon capsules and order a recall of any distributed product because MSN's bioequivalence stud | 505(q) | 2023-05-17 | Denied | McDermott Will & Emery LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$341.85
per ea
Lowest NADAC/Unit
$341.85
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69238254803TASIMELTEON 20 MG CAPSULE | $341.85 | 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.