grepcent public filings, reorganized for comparison

ARISTADA INITIO KIT — FDA application NDA209830

Application NDA209830 · type NDA · FDA status: approved · original approval 2018-06-29

Listed sponsor: ALKERMES INC · ALKS 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
001ARISTADA INITIO KITARIPIPRAZOLE LAUROXILSUSPENSION, EXTENDED RELEASEINTRAMUSCULAR675MG/2.4ML (281.25MG/ML)Prescriptionnot 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 10112903001listed patent expiry date: 2030-06-24drug substance, U-543
Patent 8796276001listed patent expiry date: 2030-06-24U-543
Patent 8431576001listed patent expiry date: 2030-10-26drug substance
Patent 10688091001listed patent expiry date: 2035-08-17drug product
Patent 10849894001listed patent expiry date: 2035-08-17U-543
Patent 11154552001listed patent expiry date: 2035-08-17drug product
Patent 10016415001listed patent expiry date: 2035-09-08drug product
Patent 11273158001listed patent expiry date: 2039-04-06U-543
Patent 12251381001listed patent expiry date: 2039-04-06U-543
NDA209830 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209830 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209830 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 marker0.001.002.002018-06-291.002030-06-241.002030-10-261.002035-08-171.002035-09-081.002039-04-061.00

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.