VORTIOXETINE HYDROBROMIDE | N204447 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
H. Lundbeck A/S et al v. Lupin Limited et al 1 patentANDA 211105vortioxetine hydrobromide | D. Del. | 2018-05-21 | 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 | — |
H. Lundbeck A/S et al v. Lupin Limited et al 3 patentsANDA 211105vortioxetine hydrobromide | D. Del. | 2018-01-12 | Terminated 2021-10-29 | — |
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. 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 | — |
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 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. |
Citizen Petition from Apotex Inc. FDA-2017-P-5967 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that the FDA determine whether TRINTELLIX (Vortioxetine) Tablets, 15 mg, approved under NDA N204447, was voluntarily withdrawn for safety or effectiveness reasons. Apotex seeks this determination to enable approval of an ANDA | 505(q) | 2017-09-28 | Withdrawn | Apotex Inc. |
Citizen Petition from Cipla Limited FDA-2017-P-5910 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whether TRINTELLIX (Vortioxetine) Tablets, 15 mg, the reference listed drug approved under NDA N204447, was voluntarily withdrawn from sale for reasons of safety or effectiveness, to enable Cipla t | 505(q) | 2017-09-25 | Withdrawn | Cipla Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| 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 |