FDA Orange Book
Is there a generic for Nuplazid?
Nuplazid contains pimavanserin. 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 Nuplazid (pimavanserin). The Orange Book shows its last listed patent expires February 27, 2039 and its last listed exclusivity ends October 27, 2029.
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Nuplazid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 34MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 17MG BASE | Discontinued | None | 0 | None |
NDA 210793, 207318, held by ACADIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nuplazid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7659285 | August 24, 2026 | Method of use | U-1844 | 210793 |
| 7732615 | June 3, 2028 | Drug substance, Drug product | None | 210793 |
| 7732615*PED | December 3, 2028 | Method of use | None | 210793 |
| 7601740 | April 29, 2030 | Drug substance, Drug product | None | 210793 |
| 7601740*PED | October 29, 2030 | Method of use | None | 210793 |
| 10517860 | March 23, 2037 | Method of use | U-1974 | 207318 |
| 10953000 | March 23, 2037 | Method of use | U-1974 | 207318 |
| 10953000*PED | September 23, 2037 | Method of use | None | 207318 |
| 10517860*PED | September 23, 2037 | Method of use | None | 207318 |
| 10849891 | August 27, 2038 | Drug product | U-1974 | 210793 |
| 11452721 | August 27, 2038 | Drug product | None | 210793 |
| 10449185 | August 27, 2038 | Drug product | None | 210793 |
| 10646480 | August 27, 2038 | Drug product | None | 210793 |
| 10449185*PED | February 27, 2039 | Method of use | None | 210793 |
| 10646480*PED | February 27, 2039 | Method of use | None | 210793 |
| 10849891*PED | February 27, 2039 | Method of use | None | 210793 |
| 11452721*PED | February 27, 2039 | Method of use | None | 210793 |
Nuplazid exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | April 27, 2029 | 210793 |
| PED | Pediatric exclusivity | October 27, 2029 | 210793 |
Nuplazid NDC codes
Questions
Is there a generic for Nuplazid?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nuplazid (pimavanserin). The Orange Book shows its last listed patent expires February 27, 2039 and its last listed exclusivity ends October 27, 2029.
What is the generic name for Nuplazid?
The active ingredient in Nuplazid is pimavanserin, per the FDA Orange Book.
When does the Nuplazid patent expire?
The last patent listed for Nuplazid in the Orange Book expires February 27, 2039. 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.