# NUPLAZID — FDA application NDA207318

Informational only - not investment advice.

Application NDA207318 · type NDA · FDA status: approved · original approval 2016-04-29

Listed sponsor: ACADIA PHARMS INC · [ACAD company profile](/company/ACAD/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | NUPLAZID | PIMAVANSERIN TARTRATE | TABLET | ORAL | EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Discontinued | not listed | Yes |
| 002 | NUPLAZID | PIMAVANSERIN TARTRATE | TABLET | ORAL | EQ 10MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7659285, product 001; listed patent expiry date: 2026-08-24.
- Patent 7659285, product 002; listed patent expiry date: 2026-08-24.
- Patent 7732615, product 001; listed patent expiry date: 2028-06-03.
- Patent 7732615, product 002; listed patent expiry date: 2028-06-03.
- Patent 7732615, product 001; listed patent expiry date: 2028-12-03.
- Patent 7732615, product 002; listed patent expiry date: 2028-12-03.
- Patent 7601740, product 001; listed patent expiry date: 2030-04-29.
- Patent 7601740, product 002; listed patent expiry date: 2030-04-29.
- Patent 7601740, product 001; listed patent expiry date: 2030-10-29.
- Patent 7601740, product 002; listed patent expiry date: 2030-10-29.
- Patent 10517860, product 002; listed patent expiry date: 2037-03-23.
- Patent 10953000, product 002; listed patent expiry date: 2037-03-23.
- Patent 10517860, product 002; listed patent expiry date: 2037-09-23.
- Patent 10953000, product 002; listed patent expiry date: 2037-09-23.
- Exclusivity M-14, product 001; listed exclusivity date: 2029-04-27.
- Exclusivity M-14, product 002; listed exclusivity date: 2029-04-27.
- Exclusivity PED, product 001; listed exclusivity date: 2029-10-27.
- Exclusivity PED, product 002; listed exclusivity date: 2029-10-27.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- PIMAVANSERIN TARTRATE · UNII NA83F1SJSR · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ACAD/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA207318. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.