# VRAYLAR — FDA application NDA204370

Informational only - not investment advice.

Application NDA204370 · type NDA · FDA status: approved · original approval 2015-09-17

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · 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 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 1.5MG BASE | Prescription | not listed | Yes |
| 002 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 3MG BASE | Prescription | not listed | Yes |
| 003 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 4.5MG BASE | Prescription | not listed | Yes |
| 004 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 6MG BASE | Prescription | not listed | Yes |
| 005 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 0.5MG BASE | Prescription | not listed | Yes |
| 006 | VRAYLAR | CARIPRAZINE HYDROCHLORIDE | CAPSULE | ORAL | EQ 0.75MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7943621, product 001; listed patent expiry date: 2028-12-16.
- Patent 7943621, product 002; listed patent expiry date: 2028-12-16.
- Patent 7943621, product 003; listed patent expiry date: 2028-12-16.
- Patent 7943621, product 004; listed patent expiry date: 2028-12-16.
- Patent 7943621, product 005; listed patent expiry date: 2028-12-20.
- Patent 7943621, product 006; listed patent expiry date: 2028-12-20.
- Patent 7943621, product 001; listed patent expiry date: 2029-06-16.
- Patent 7943621, product 002; listed patent expiry date: 2029-06-16.
- Patent 7943621, product 003; listed patent expiry date: 2029-06-16.
- Patent 7943621, product 004; listed patent expiry date: 2029-06-16.
- Patent 7943621, product 005; listed patent expiry date: 2029-06-20.
- Patent 7943621, product 006; listed patent expiry date: 2029-06-20.
- Patent RE47350, product 001; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 001; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 001; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 001; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 001; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 005; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 005; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 005; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 005; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 006; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 006; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 006; listed patent expiry date: 2029-07-16.
- Patent RE47350, product 006; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 005; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 005; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 005; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 005; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 006; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 006; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 006; listed patent expiry date: 2029-07-16.
- Patent RE49110, product 006; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 001; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 002; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 003; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 004; listed patent expiry date: 2029-07-16.
- Patent RE49302, product 004; listed patent expiry date: 2029-07-16.
- Patent 7737142, product 001; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 001; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 001; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 001; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 001; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 002; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 002; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 002; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 002; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 002; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 003; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 003; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 003; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 004; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 004; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 004; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 005; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 005; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 005; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 005; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 006; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 006; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 006; listed patent expiry date: 2029-09-17.
- Patent 7737142, product 006; listed patent expiry date: 2029-09-17.
- Patent RE47350, product 001; listed patent expiry date: 2030-01-16.
- Patent RE47350, product 005; listed patent expiry date: 2030-01-16.
- Patent RE47350, product 006; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 001; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 002; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 003; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 004; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 005; listed patent expiry date: 2030-01-16.
- Patent RE49110, product 006; listed patent expiry date: 2030-01-16.
- Patent RE49302, product 001; listed patent expiry date: 2030-01-16.
- Patent RE49302, product 002; listed patent expiry date: 2030-01-16.
- Patent RE49302, product 003; listed patent expiry date: 2030-01-16.
- Patent RE49302, product 004; listed patent expiry date: 2030-01-16.
- Patent 7737142, product 001; listed patent expiry date: 2030-03-17.
- Patent 7737142, product 002; listed patent expiry date: 2030-03-17.
- Patent 7737142, product 003; listed patent expiry date: 2030-03-17.
- Patent 7737142, product 004; listed patent expiry date: 2030-03-17.
- Patent 7737142, product 005; listed patent expiry date: 2030-03-17.
- Patent 7737142, product 006; listed patent expiry date: 2030-03-17.
- Exclusivity M-14, product 001; listed exclusivity date: 2028-12-18.
- Exclusivity M-14, product 002; listed exclusivity date: 2028-12-18.
- Exclusivity M-14, product 003; listed exclusivity date: 2028-12-18.
- Exclusivity M-14, product 004; listed exclusivity date: 2028-12-18.
- Exclusivity M-14, product 005; listed exclusivity date: 2028-12-18.
- Exclusivity M-14, product 006; listed exclusivity date: 2028-12-18.
- Exclusivity NPP, product 001; listed exclusivity date: 2028-12-18.
- Exclusivity NPP, product 002; listed exclusivity date: 2028-12-18.
- Exclusivity NPP, product 003; listed exclusivity date: 2028-12-18.
- Exclusivity NPP, product 005; listed exclusivity date: 2028-12-18.
- Exclusivity NPP, product 006; listed exclusivity date: 2028-12-18.
- Exclusivity PED, product 001; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 001; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 002; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 002; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 003; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 003; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 004; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 005; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 005; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 006; listed exclusivity date: 2029-06-18.
- Exclusivity PED, product 006; listed exclusivity date: 2029-06-18.

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

- CARIPRAZINE · UNII F6RJL8B278 · no lmmol compound match

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/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA204370. FDA data retrieved 2026-08-07.

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