ARISTADA — FDA application NDA207533
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
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 441MG/1.6ML (275.63MG/ML) | Prescription | not listed | Yes |
| 002 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 662MG/2.4ML (275.83MG/ML) | Prescription | not listed | Yes |
| 003 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 882MG/3.2ML (275.63MG/ML) | Prescription | not listed | Yes |
| 004 | ARISTADA | ARIPIPRAZOLE LAUROXIL | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 1064MG/3.9ML (272.82MG/ML) | Prescription | not listed | Yes |
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
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10112903 | 001 | listed patent expiry date: 2030-06-24 | drug substance, U-543 |
| Patent 10112903 | 002 | listed patent expiry date: 2030-06-24 | drug substance, U-543 |
| Patent 10112903 | 003 | listed patent expiry date: 2030-06-24 | drug substance, U-543 |
| Patent 10112903 | 004 | listed patent expiry date: 2030-06-24 | drug substance, U-543 |
| Patent 8796276 | 001 | listed patent expiry date: 2030-06-24 | U-543 |
| Patent 8796276 | 002 | listed patent expiry date: 2030-06-24 | U-543 |
| Patent 8796276 | 003 | listed patent expiry date: 2030-06-24 | U-543 |
| Patent 8796276 | 004 | listed patent expiry date: 2030-06-24 | U-543 |
| Patent 8431576 | 001 | listed patent expiry date: 2030-10-26 | drug substance |
| Patent 8431576 | 002 | listed patent expiry date: 2030-10-26 | drug substance |
| Patent 8431576 | 003 | listed patent expiry date: 2030-10-26 | drug substance |
| Patent 8431576 | 004 | listed patent expiry date: 2030-10-26 | drug substance |
| Patent 10226458 | 001 | listed patent expiry date: 2032-03-19 | U-543 |
| Patent 10226458 | 002 | listed patent expiry date: 2032-03-19 | U-543 |
| Patent 10226458 | 003 | listed patent expiry date: 2032-03-19 | U-543 |
| Patent 10226458 | 004 | listed patent expiry date: 2032-03-19 | U-543 |
| Patent 9034867 | 001 | listed patent expiry date: 2032-11-07 | drug product, U-543 |
| Patent 9034867 | 002 | listed patent expiry date: 2032-11-07 | drug product, U-543 |
| Patent 9034867 | 003 | listed patent expiry date: 2032-11-07 | drug product, U-543 |
| Patent 9034867 | 004 | listed patent expiry date: 2032-11-07 | drug product, U-543 |
| Patent 12629366 | 001 | listed patent expiry date: 2032-12-06 | drug product, U-764 |
| Patent 12629366 | 002 | listed patent expiry date: 2032-12-06 | drug product, U-764 |
| Patent 12629366 | 003 | listed patent expiry date: 2032-12-06 | drug product, U-764 |
| Patent 12629366 | 004 | listed patent expiry date: 2032-12-06 | drug product, U-764 |
| Patent 11097006 | 001 | listed patent expiry date: 2033-09-19 | drug product, U-764 |
| Patent 11097006 | 002 | listed patent expiry date: 2033-09-19 | drug product, U-764 |
| Patent 11097006 | 003 | listed patent expiry date: 2033-09-19 | drug product, U-764 |
| Patent 11097006 | 004 | listed patent expiry date: 2033-09-19 | drug product, U-764 |
| Patent 12311027 | 001 | listed patent expiry date: 2033-09-19 | drug product, U-543 |
| Patent 12311027 | 002 | listed patent expiry date: 2033-09-19 | drug product, U-543 |
| Patent 12311027 | 003 | listed patent expiry date: 2033-09-19 | drug product, U-543 |
| Patent 12311027 | 004 | listed patent expiry date: 2033-09-19 | drug product, U-543 |
| Patent 9193685 | 001 | listed patent expiry date: 2033-10-24 | drug product, U-543 |
| Patent 9193685 | 002 | listed patent expiry date: 2033-10-24 | drug product, U-543 |
| Patent 9193685 | 003 | listed patent expiry date: 2033-10-24 | drug product, U-543 |
| Patent 9193685 | 004 | listed patent expiry date: 2033-10-24 | drug product, U-543 |
| Patent 11969469 | 001 | listed patent expiry date: 2034-04-06 | drug product |
| Patent 11969469 | 002 | listed patent expiry date: 2034-04-06 | drug product |
| Patent 11969469 | 003 | listed patent expiry date: 2034-04-06 | drug product |
| Patent 11969469 | 004 | listed patent expiry date: 2034-04-06 | drug product |
| Patent 10238651 | 001 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 10238651 | 002 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 10238651 | 003 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 10238651 | 004 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 10813928 | 001 | listed patent expiry date: 2035-03-19 | U-2983 |
| Patent 10813928 | 002 | listed patent expiry date: 2035-03-19 | U-2983 |
| Patent 10813928 | 003 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 10813928 | 004 | listed patent expiry date: 2035-03-19 | U-2983 |
| Patent 11406632 | 001 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 11406632 | 002 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 11406632 | 003 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 11406632 | 004 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 9452131 | 001 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 9452131 | 002 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 9452131 | 003 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 9452131 | 004 | listed patent expiry date: 2035-03-19 | U-2402 |
| Patent 9526726 | 002 | listed patent expiry date: 2035-03-19 | drug product |
| Patent 9526726 | 003 | listed patent expiry date: 2035-03-19 | drug product |
| Patent 11273158 | 001 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 11273158 | 002 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 11273158 | 003 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 11273158 | 004 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 12251381 | 001 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 12251381 | 002 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 12251381 | 003 | listed patent expiry date: 2039-04-06 | U-543 |
| Patent 12251381 | 004 | listed patent expiry date: 2039-04-06 | U-543 |
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 · CHEMBL2219425
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.