TASIMELTEON | A211601 | TEVA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2021-01-29 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 2 patentsANDA 211601tasimelteon | D. Del. | 2020-08-21 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2020-01-22 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2019-11-26 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2019-03-22 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 6 patentsANDA 211601tasimelteon | D. Del. | 2018-04-30 | Terminated 2022-12-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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-0313 · 33 docket documents Vanda Pharmaceuticals Inc. filed this petition through counsel at McDermott Will & Emery LLP requesting that the FDA revoke approval of ANDA No. 211601 for Teva Pharmaceuticals USA Inc.'s 20 mg tasimelteon capsules and order its recall, arguing that Teva's product labeling fails to comply with the r | 505(q) | 2023-01-26 | 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 |
|---|---|---|---|---|---|
| 00480449056TASIMELTEON 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.