FDA Orange Book
Is there a generic for Trintellix?
Trintellix contains vortioxetine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trintellix (vortioxetine). The Orange Book shows its last listed patent expires September 21, 2032 and its last listed exclusivity ends February 23, 2027.
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Trintellix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 15MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 204447, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Trintellix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7144884 | June 17, 2026 | Drug substance, Drug product | U-1439 | 204447 |
| 7144884*PED | December 17, 2026 | Method of use | None | 204447 |
| 9227946 | June 15, 2027 | Method of use | U-1668 | 204447 |
| 9861630 | June 15, 2027 | Method of use | U-1668 | 204447 |
| 9125908 | June 15, 2027 | Method of use | U-2309 | 204447 |
| 9125910 | June 15, 2027 | Method of use | U-2309 | 204447 |
| 9125909 | June 15, 2027 | Method of use | U-2309 | 204447 |
| 11458134 | June 15, 2027 | Drug product | U-3463 | 204447 |
| 8969355 | June 15, 2027 | Method of use | U-1668 | 204447 |
| 8969355*PED | December 15, 2027 | Method of use | None | 204447 |
| 9227946*PED | December 15, 2027 | Method of use | None | 204447 |
| 9125908*PED | December 15, 2027 | Method of use | None | 204447 |
| 9125909*PED | December 15, 2027 | Method of use | None | 204447 |
| 9125910*PED | December 15, 2027 | Method of use | None | 204447 |
| 9861630*PED | December 15, 2027 | Method of use | None | 204447 |
| 11458134*PED | December 15, 2027 | Method of use | None | 204447 |
| 8722684 | June 30, 2031 | Drug substance, Drug product | None | 204447 |
| 8722684*PED | December 30, 2031 | Method of use | None | 204447 |
| 9278096 | March 21, 2032 | Method of use | U-2436 | 204447 |
| 9278096*PED | September 21, 2032 | Method of use | None | 204447 |
Trintellix exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-232 | Miscellaneous | August 23, 2026 | 204447 |
| PED | Pediatric exclusivity | February 23, 2027 | 204447 |
Trintellix NDC codes
Questions
Is there a generic for Trintellix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Trintellix (vortioxetine). The Orange Book shows its last listed patent expires September 21, 2032 and its last listed exclusivity ends February 23, 2027.
What is the generic name for Trintellix?
The active ingredient in Trintellix is vortioxetine, per the FDA Orange Book.
When does the Trintellix patent expire?
The last patent listed for Trintellix in the Orange Book expires September 21, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.