TASIMELTEON | A211607 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-10-01 | Terminated 2022-12-14 | — | |
| D. Del. | 2020-01-21 | Terminated 2022-12-14 | — | |
| D. Del. | 2019-12-30 | Terminated 2022-12-14 | — | |
| D. Del. | 2019-04-12 | Terminated 2022-12-14 | — | |
| D. Del. | 2018-05-07 | Terminated 2022-12-14 | — |
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 |
Citizen Petition from McDermott Will & Emery (on behalf of Vanda Pharmaceutic... FDA-2023-P-1388 · 17 docket documents Vanda Pharmaceuticals Inc., through counsel at McDermott Will & Emery, filed this citizen petition under 21 U.S.C. § 355(j) requesting that FDA revoke approval of ANDA No. 211601 submitted by Teva Pharmaceuticals USA, Inc. for 20 mg tasimelteon capsules and order a recall of the product, arguing tha | 505(q) | 2023-04-11 | Denied | Vanda Pharmaceuticals Inc. |
Citizen Petition from McDermott Will & Emery, LLP FDA-2023-P-0344 · 8 docket documents Vanda Pharmaceuticals Inc. filed this citizen petition on January 27, 2023, requesting that the FDA revoke approval of ANDA No. 211607 submitted by Apotex Inc. and Apotex Corp for 20 mg tasimelteon capsules, contending that Apotex's label fails to satisfy the FDCA's "same labeling" and "same conditi | 505(q) | 2023-01-30 | 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 |
|---|---|---|---|---|---|
| 60505466503TASIMELTEON 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.