FDA Orange Book
Is there a generic for Spravato?
Spravato contains esketamine. 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 Spravato (esketamine). The Orange Book shows its last listed patent expires February 18, 2040 and its last listed exclusivity ends January 17, 2028.
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Spravato products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | EQ 28MG BASE | Marketed (Rx) | None | 0 | None |
NDA 211243, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Spravato patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9592207 | March 20, 2027 | Method of use | U-2502 | 211243 |
| 9592207 | March 20, 2027 | Method of use | U-4112 | 211243 |
| 8785500 | March 5, 2033 | Method of use | U-2502 | 211243 |
| 8785500 | March 5, 2033 | Method of use | U-4112 | 211243 |
| 11446260 | March 14, 2034 | Method of use | U-4118 | 211243 |
| 11446260 | March 14, 2034 | Method of use | U-4119 | 211243 |
| 11446260 | March 14, 2034 | Method of use | U-3444 | 211243 |
| 11446260 | March 14, 2034 | Method of use | U-3445 | 211243 |
| 11446260 | March 14, 2034 | Method of use | U-3446 | 211243 |
| 10869844 | September 10, 2035 | Method of use | U-4113 | 211243 |
| 10869844 | September 10, 2035 | Method of use | U-4114 | 211243 |
| 11173134 | September 10, 2035 | Method of use | U-4115 | 211243 |
| 11311500 | September 10, 2035 | Method of use | U-4116 | 211243 |
| 11311500 | September 10, 2035 | Method of use | U-4117 | 211243 |
| 11173134 | September 10, 2035 | Method of use | U-3536 | 211243 |
| 11311500 | September 10, 2035 | Method of use | U-3034 | 211243 |
| 11311500 | September 10, 2035 | Method of use | U-3036 | 211243 |
| 11311500 | September 10, 2035 | Method of use | U-3035 | 211243 |
| 11173134 | September 10, 2035 | Method of use | U-3257 | 211243 |
| 10869844 | September 10, 2035 | Method of use | U-3035 | 211243 |
| 10869844 | September 10, 2035 | Method of use | U-3034 | 211243 |
| 10869844 | September 10, 2035 | Method of use | U-3036 | 211243 |
| 11883526 | February 18, 2040 | Method of use | U-4120 | 211243 |
| 11883526 | February 18, 2040 | Method of use | U-3812 | 211243 |
| 11883526 | February 18, 2040 | Method of use | U-3813 | 211243 |
Spravato exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-959 | New indication | January 17, 2028 | 211243 |
Spravato NDC codes
Questions
Is there a generic for Spravato?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Spravato (esketamine). The Orange Book shows its last listed patent expires February 18, 2040 and its last listed exclusivity ends January 17, 2028.
What is the generic name for Spravato?
The active ingredient in Spravato is esketamine, per the FDA Orange Book.
When does the Spravato patent expire?
The last patent listed for Spravato in the Orange Book expires February 18, 2040. 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.