VORTIOXETINE HYDROBROMIDE | N204447 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2018-07-12 | Terminated 2020-02-20 | — | |
| D. Del. | 2018-06-07 | Terminated 2021-10-29 | — | |
H. Lundbeck A/S et al v. Lupin Limited et al 1 patentANDA 211105vortioxetine hydrobromide | D. Del. | 2018-05-21 | Terminated 2021-10-29 | — |
| D. Del. | 2018-05-17 | Terminated 2020-04-22 | — | |
| E.D. Pa. | 2018-05-04 | Terminated 2018-07-27 | — | |
| D. Del. | 2018-05-03 | Terminated 2020-11-23 | — | |
| D. Del. | 2018-05-03 | Terminated 2021-10-29 | — | |
H. Lundbeck A/S et al v. Sandoz Inc. et al 3 patentsANDA 210993vortioxetine hydrobromide | D. Del. | 2018-01-30 | Terminated 2021-10-29 | — |
| D. Del. | 2018-01-30 | Terminated 2018-12-27 | — | |
| D. Del. | 2018-01-30 | Terminated 2020-05-21 | — | |
| D. Del. | 2018-01-25 | Terminated 2020-11-23 | — | |
| D. Del. | 2018-01-25 | Terminated 2020-04-22 | — | |
| D. Del. | 2018-01-25 | Terminated 2020-09-24 | — | |
| D. Del. | 2018-01-25 | Terminated 2021-10-29 | — | |
| D. Del. | 2018-01-19 | Terminated 2021-01-19 | — | |
| D. Del. | 2018-01-19 | Terminated 2021-10-29 | — | |
H. Lundbeck A/S et al v. Unichem Laboratories, Limited 3 patentsANDA 211131vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2020-06-18 | — |
H. Lundbeck A/S et al v. Macleods Pharmaceuticals Limited et al 3 patentsANDA 211165vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2021-10-29 | — |
H. Lundbeck A/S et al v. Alkem Laboratories Limited 3 patentsANDA 211089vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2021-01-05 | — |
H. Lundbeck A/S et al v. Lupin Limited, et al 3 patentsANDA 211130vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2021-10-28 | — |
H. Lundbeck A/S et al v. Lupin Limited et al 3 patentsANDA 211105vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2021-10-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Takeda Pharmaceuticals U.S.A., Inc. and H. Lundbeck A/S FDA-2019-P-0837 · 25 docket documents Takeda Pharmaceuticals U.S.A., Inc. and H. Lundbeck A/S filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require labeling for any ANDA or section 505(b)(2) application referencing TRINTELLIX (vortioxetine) to include information abo | 505(q) | 2019-02-21 | Open | Takeda Pharmaceuticals U.S.A., Inc. and H. Lundbeck A/S |
Citizen Petition from Apotex Inc. FDA-2017-P-5967 · 5 docket documents Apotex Inc. filed this citizen petition on September 27, 2017, requesting that the FDA determine whether TRINTELLIX (Vortioxetine) Tablets, 15 mg, approved under NDA N204447, was voluntarily withdrawn for safety or effectiveness reasons. Apotex seeks this determination to enable approval of an ANDA | 505(q) | 2017-09-28 | Granted | Apotex Inc. |
Citizen Petition from Goodwin Procter LLP FDA-2017-P-5909 · 4 docket documents Scott M. Lassman of Goodwin Procter LLP filed this citizen petition requesting that the FDA determine that Trintellix (vortioxetine) tablets, 15 mg strength, was voluntarily withdrawn from the market for reasons other than safety or effectiveness. The petitioner notes that although the 15 mg strengt | 505(q) | 2017-09-26 | Granted | Goodwin Procter LLP |
Citizen Petition from Cipla Limited FDA-2017-P-5910 · 4 docket documents Cipla Limited submitted this citizen petition on September 25, 2017, requesting that the FDA determine whether TRINTELLIX (Vortioxetine) Tablets, 15 mg, the reference listed drug approved under NDA N204447, was voluntarily withdrawn from sale for reasons of safety or effectiveness, to enable Cipla t | 505(q) | 2017-09-25 | Granted | Cipla Limited |
Citizen Petition from Locke Lord LLP FDA-2017-P-5114 · 7 docket documents Locke Lord LLP filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether the 15 mg strength of TRINTELLIX (vortioxetine hydrobromide), approved under NDA N204447, was discontinued for safety or effectiveness reasons. If FDA determines the discontinuatio | 505(q) | 2017-08-22 | Granted | Locke Lord LLP |
Citizen Petition from INC Research, LLC FDA-2017-P-4195 · 4 docket documents INC Research, LLC filed this citizen petition pursuant to 21 CFR §10.30 and 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that the discontinuation of the 15 mg strength of TRINTELLIX (vortioxetine) NDA 204447 was not for safety or effectiveness | 505(q) | 2017-07-14 | Granted | INC Research, LLC |
Citizen Petition from Lachman Consultant Services, Inc FDA-2017-P-3989 · 7 docket documents Lachman Consultant Services, Inc., filed this citizen petition on behalf of a client requesting that the FDA determine whether the 15 mg strength of Takeda Pharmaceuticals USA, Inc.'s TRINTELLIX (vortioxetine hydrobromide) tablets, approved under NDA N204447, was discontinued for safety or effective | 505(q) | 2017-06-29 | Granted | Lachman Consultant Services, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$17.23
per ea
Lowest NADAC/Unit
$17.21
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 64764075030TRINTELLIX 20 MG TABLET | $17.23 | EA | Brand | — | 2026-06-17 |
| 64764072030TRINTELLIX 5 MG TABLET | $17.21 | EA | Brand | — | 2026-06-17 |
| 64764073030TRINTELLIX 10 MG TABLET | $17.21 | EA | Brand | — | 2026-06-17 |
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 |
|---|---|---|---|---|---|---|
| 7144884 | Jun 17, 2026PED: Dec 17, 2026 | PED | Yes | Yes | — | |
| 8722684 | Jun 30, 2031PED: Dec 30, 2031 | PED | Yes | Yes | — | — |
| 8969355 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 9125908 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 9125909 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 9125910 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 9227946 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 9278096 | Mar 21, 2032PED: Sep 21, 2032 | PED | — | — | — | |
| 9861630 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | — | — | |
| 11458134 | Jun 15, 2027PED: Dec 15, 2027 | PED | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| M-232 | Aug 23, 2026 | < 1 year |
| PED | Feb 23, 2027 | < 1 year |