# ARISTADA — FDA application NDA207533 Informational only - not investment advice. Application NDA207533 · type NDA · FDA status: approved · original approval 2015-10-05 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 | 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 | ## Orange Book patent and exclusivity listings - Patent 10112903, product 001; listed patent expiry date: 2030-06-24. - Patent 10112903, product 002; listed patent expiry date: 2030-06-24. - Patent 10112903, product 003; listed patent expiry date: 2030-06-24. - Patent 10112903, product 004; listed patent expiry date: 2030-06-24. - Patent 8796276, product 001; listed patent expiry date: 2030-06-24. - Patent 8796276, product 002; listed patent expiry date: 2030-06-24. - Patent 8796276, product 003; listed patent expiry date: 2030-06-24. - Patent 8796276, product 004; listed patent expiry date: 2030-06-24. - Patent 8431576, product 001; listed patent expiry date: 2030-10-26. - Patent 8431576, product 002; listed patent expiry date: 2030-10-26. - Patent 8431576, product 003; listed patent expiry date: 2030-10-26. - Patent 8431576, product 004; listed patent expiry date: 2030-10-26. - Patent 10226458, product 001; listed patent expiry date: 2032-03-19. - Patent 10226458, product 002; listed patent expiry date: 2032-03-19. - Patent 10226458, product 003; listed patent expiry date: 2032-03-19. - Patent 10226458, product 004; listed patent expiry date: 2032-03-19. - Patent 9034867, product 001; listed patent expiry date: 2032-11-07. - Patent 9034867, product 002; listed patent expiry date: 2032-11-07. - Patent 9034867, product 003; listed patent expiry date: 2032-11-07. - Patent 9034867, product 004; listed patent expiry date: 2032-11-07. - Patent 12629366, product 001; listed patent expiry date: 2032-12-06. - Patent 12629366, product 002; listed patent expiry date: 2032-12-06. - Patent 12629366, product 003; listed patent expiry date: 2032-12-06. - Patent 12629366, product 004; listed patent expiry date: 2032-12-06. - Patent 11097006, product 001; listed patent expiry date: 2033-09-19. - Patent 11097006, product 002; listed patent expiry date: 2033-09-19. - Patent 11097006, product 003; listed patent expiry date: 2033-09-19. - Patent 11097006, product 004; listed patent expiry date: 2033-09-19. - Patent 12311027, product 001; listed patent expiry date: 2033-09-19. - Patent 12311027, product 002; listed patent expiry date: 2033-09-19. - Patent 12311027, product 003; listed patent expiry date: 2033-09-19. - Patent 12311027, product 004; listed patent expiry date: 2033-09-19. - Patent 9193685, product 001; listed patent expiry date: 2033-10-24. - Patent 9193685, product 002; listed patent expiry date: 2033-10-24. - Patent 9193685, product 003; listed patent expiry date: 2033-10-24. - Patent 9193685, product 004; listed patent expiry date: 2033-10-24. - Patent 11969469, product 001; listed patent expiry date: 2034-04-06. - Patent 11969469, product 002; listed patent expiry date: 2034-04-06. - Patent 11969469, product 003; listed patent expiry date: 2034-04-06. - Patent 11969469, product 004; listed patent expiry date: 2034-04-06. - Patent 10238651, product 001; listed patent expiry date: 2035-03-19. - Patent 10238651, product 002; listed patent expiry date: 2035-03-19. - Patent 10238651, product 003; listed patent expiry date: 2035-03-19. - Patent 10238651, product 004; listed patent expiry date: 2035-03-19. - Patent 10813928, product 001; listed patent expiry date: 2035-03-19. - Patent 10813928, product 002; listed patent expiry date: 2035-03-19. - Patent 10813928, product 003; listed patent expiry date: 2035-03-19. - Patent 10813928, product 004; listed patent expiry date: 2035-03-19. - Patent 11406632, product 001; listed patent expiry date: 2035-03-19. - Patent 11406632, product 002; listed patent expiry date: 2035-03-19. - Patent 11406632, product 003; listed patent expiry date: 2035-03-19. - Patent 11406632, product 004; listed patent expiry date: 2035-03-19. - Patent 9452131, product 001; listed patent expiry date: 2035-03-19. - Patent 9452131, product 002; listed patent expiry date: 2035-03-19. - Patent 9452131, product 003; listed patent expiry date: 2035-03-19. - Patent 9452131, product 004; listed patent expiry date: 2035-03-19. - Patent 9526726, product 002; listed patent expiry date: 2035-03-19. - Patent 9526726, product 003; listed patent expiry date: 2035-03-19. - Patent 11273158, product 001; listed patent expiry date: 2039-04-06. - Patent 11273158, product 002; listed patent expiry date: 2039-04-06. - Patent 11273158, product 003; listed patent expiry date: 2039-04-06. - Patent 11273158, product 004; listed patent expiry date: 2039-04-06. - Patent 12251381, product 001; listed patent expiry date: 2039-04-06. - Patent 12251381, product 002; listed patent expiry date: 2039-04-06. - Patent 12251381, product 003; listed patent expiry date: 2039-04-06. - Patent 12251381, product 004; 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:NDA207533. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.