FDA Orange Book
Is there a generic for Caplyta?
Caplyta contains lumateperone. 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 Caplyta (lumateperone). The Orange Book shows its last listed patent expires December 10, 2040 and its last listed exclusivity ends April 24, 2029.
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Caplyta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 21MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 42MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209500, held by INTRA-CELLULAR THERAPIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Caplyta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10464938 | March 12, 2028 | Drug product | None | 209500 |
| 9199995 | March 12, 2029 | Method of use | U-4343 | 209500 |
| 9199995 | March 12, 2029 | Method of use | U-2713 | 209500 |
| RE48825 | March 12, 2029 | Drug substance | None | 209500 |
| 9586960 | March 12, 2029 | Drug substance, Drug product | None | 209500 |
| 10117867 | May 27, 2029 | Method of use | U-3271 | 209500 |
| 9168258 | May 27, 2029 | Drug product | None | 209500 |
| 9616061 | May 27, 2029 | Drug product | None | 209500 |
| 8648077 | December 1, 2029 | Drug substance, Drug product | None | 209500 |
| 8598119 | December 28, 2029 | Method of use | U-543 | 209500 |
| RE48839 | August 19, 2033 | Method of use | U-4344 | 209500 |
| RE48839 | August 19, 2033 | Method of use | U-3271 | 209500 |
| RE48839 | August 19, 2033 | Method of use | U-814 | 209500 |
| 11026951 | December 3, 2034 | Method of use | U-3364 | 209500 |
| 9956227 | December 3, 2034 | Method of use | U-2714 | 209500 |
| 10960009 | December 3, 2034 | Method of use | U-814 | 209500 |
| 11026951 | December 3, 2034 | Method of use | U-3274 | 209500 |
| 12409176 | March 15, 2039 | Method of use | U-4261 | 209500 |
| 11806348 | August 30, 2039 | Drug product | U-3363 | 209500 |
| 11806348 | August 30, 2039 | Drug product | U-3362 | 209500 |
| 11806348 | August 30, 2039 | Drug product | U-4341 | 209500 |
| 11690842 | August 30, 2039 | Drug product | U-4341 | 209500 |
| 11052084 | August 30, 2039 | Drug product | U-4341 | 209500 |
| 11690842 | August 30, 2039 | Drug product | U-3362 | 209500 |
| 11690842 | August 30, 2039 | Drug product | U-3363 | 209500 |
| 11052084 | August 30, 2039 | Drug product | U-3362 | 209500 |
| 11052084 | August 30, 2039 | Drug product | U-3363 | 209500 |
| 10695345 | August 30, 2039 | Drug product | U-814 | 209500 |
| 10695345 | August 30, 2039 | Drug product | U-543 | 209500 |
| 12128043 | August 30, 2039 | Drug product | U-3362 | 209500 |
| 12128043 | August 30, 2039 | Drug product | U-3363 | 209500 |
| 12070459 | August 30, 2039 | Drug product | U-3362 | 209500 |
| 12070459 | August 30, 2039 | Drug product | U-3363 | 209500 |
| 12070459 | August 30, 2039 | Drug product | U-4341 | 209500 |
| 11980617 | October 27, 2039 | Method of use | U-4342 | 209500 |
| 11980617 | October 27, 2039 | Method of use | U-3940 | 209500 |
| 12090155 | July 7, 2040 | Drug product | U-4000 | 209500 |
| 12122792 | December 10, 2040 | Drug product | U-4019 | 209500 |
| 12122792 | December 10, 2040 | Drug product | U-4020 | 209500 |
| 12122792 | December 10, 2040 | Drug product | U-4340 | 209500 |
| 11753419 | December 10, 2040 | Drug product | None | 209500 |
| 12410195 | December 10, 2040 | Drug product | None | 209500 |
Caplyta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-904 | New indication | November 5, 2028 | 209500 |
| M-319 | Miscellaneous | April 24, 2029 | 209500 |
Caplyta NDC codes
Questions
Is there a generic for Caplyta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Caplyta (lumateperone). The Orange Book shows its last listed patent expires December 10, 2040 and its last listed exclusivity ends April 24, 2029.
What is the generic name for Caplyta?
The active ingredient in Caplyta is lumateperone, per the FDA Orange Book.
When does the Caplyta patent expire?
The last patent listed for Caplyta in the Orange Book expires December 10, 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.