grepcent public filings, reorganized for comparison

NUPLAZID — FDA application NDA207318

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

Listed sponsor: ACADIA PHARMS INC · ACAD company profile · exact_unique

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

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001NUPLAZIDPIMAVANSERIN TARTRATETABLETORALEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes
002NUPLAZIDPIMAVANSERIN TARTRATETABLETORALEQ 10MG BASEPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 7659285001listed patent expiry date: 2026-08-24U-1844
Patent 7659285002listed patent expiry date: 2026-08-24U-1844
Patent 7732615001listed patent expiry date: 2028-06-03drug substance, drug product
Patent 7732615002listed patent expiry date: 2028-06-03drug substance, drug product
Patent 7732615001listed patent expiry date: 2028-12-03pediatric extension
Patent 7732615002listed patent expiry date: 2028-12-03pediatric extension
Patent 7601740001listed patent expiry date: 2030-04-29drug substance, drug product
Patent 7601740002listed patent expiry date: 2030-04-29drug substance, drug product
Patent 7601740001listed patent expiry date: 2030-10-29pediatric extension
Patent 7601740002listed patent expiry date: 2030-10-29pediatric extension
Patent 10517860002listed patent expiry date: 2037-03-23U-1974
Patent 10953000002listed patent expiry date: 2037-03-23U-1974
Patent 10517860002listed patent expiry date: 2037-09-23pediatric extension
Patent 10953000002listed patent expiry date: 2037-09-23pediatric extension
Exclusivity M-14001listed exclusivity date: 2029-04-27FDA code as listed
Exclusivity M-14002listed exclusivity date: 2029-04-27FDA code as listed
Exclusivity PED001listed exclusivity date: 2029-10-27FDA code as listed
Exclusivity PED002listed exclusivity date: 2029-10-27FDA code as listed
NDA207318 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207318 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207318 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002016-04-291.002026-08-241.002028-06-031.002028-12-031.002029-04-271.002029-10-271.002030-04-291.002030-10-291.002037-03-231.002037-09-231.00

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

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

Related pages

Sponsor company · FDA-approved application index

Peer clusters: No published peer-cluster link for this sponsor.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

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