# ARISTADA INITIO KIT — FDA application NDA209830

Informational only - not investment advice.

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

Listed sponsor: ALKERMES INC · [ALKS company profile](/company/ALKS/) · 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 | ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 675MG/2.4ML (281.25MG/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10112903, product 001; listed patent expiry date: 2030-06-24.
- Patent 8796276, product 001; listed patent expiry date: 2030-06-24.
- Patent 8431576, product 001; listed patent expiry date: 2030-10-26.
- Patent 10688091, product 001; listed patent expiry date: 2035-08-17.
- Patent 10849894, product 001; listed patent expiry date: 2035-08-17.
- Patent 11154552, product 001; listed patent expiry date: 2035-08-17.
- Patent 10016415, product 001; listed patent expiry date: 2035-09-08.
- Patent 11273158, product 001; listed patent expiry date: 2039-04-06.
- Patent 12251381, product 001; listed patent expiry date: 2039-04-06.

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

- ARIPIPRAZOLE LAUROXIL · UNII B786J7A343 · [lmmol compound DDINXHAORAAYAD-UHFFFAOYSA-N](https://lmmol.com/compound/DDINXHAORAAYAD-UHFFFAOYSA-N)

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/ALKS/)
- [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:NDA209830. FDA data retrieved 2026-08-07.

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