vortioxetine hydrobromide · Takeda Pharms Usa · NDA 204447
Trintellix
Earliest generic entry, as listed · earliest of 3 marketed strengths
21 Sep 2032
Blocked by patent: US 9278096.
Listed patents · 19 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9278096 | — | 21 Sep 2032 |
| US 9278096 | use U-2436 | 21 Mar 2032 |
| US 8722684 | — | 30 Dec 2031 |
| US 8722684 | substance, product | 30 Jun 2031 |
| US 11458134 | — | 15 Dec 2027 |
| US 8969355 | — | 15 Dec 2027 |
| US 9125908 | — | 15 Dec 2027 |
| US 9125909 | — | 15 Dec 2027 |
| US 9125910 | — | 15 Dec 2027 |
| US 9227946 | — | 15 Dec 2027 |
| US 9861630 | — | 15 Dec 2027 |
| US 11458134 | product, use U-3463 | 15 Jun 2027 |
| US 8969355 | use U-1668 | 15 Jun 2027 |
| US 9125908 | use U-2309 | 15 Jun 2027 |
| US 9125909 | use U-2309 | 15 Jun 2027 |
| US 9125910 | use U-2309 | 15 Jun 2027 |
| US 9227946 | use U-1668 | 15 Jun 2027 |
| US 9861630 | use U-1668 | 15 Jun 2027 |
| US 7144884 | — | 17 Dec 2026 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 23 Feb 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic tentatively approved · 204447-00129 Jan 2026
- 25 Oct 2026Generic tentatively approved · 204447-0013 Nov 2025
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204447 · 001 · RLD | tablet, oral | EQ 5MG BASE | 21 Sep 2032 |
| 204447 · 002 · RLD | tablet, oral | EQ 10MG BASE | 21 Sep 2032 |
| 204447 · 003 · RLD · discontinued | tablet, oral | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 21 Sep 2032 |
| 204447 · 004 · RLD | tablet, oral | EQ 20MG BASE | 21 Sep 2032 |
Expired or delisted (2)
- US 7144884 · substance, product, use U-1439 · 17 Jun 2026
- M-232 · 23 Aug 2026