VRAYLAR — FDA application NDA204370
Listed sponsor: ABBVIE · ABBV 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 | 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 |
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 7943621 | 001 | listed patent expiry date: 2028-12-16 | drug substance, drug product |
| Patent 7943621 | 002 | listed patent expiry date: 2028-12-16 | drug substance, drug product |
| Patent 7943621 | 003 | listed patent expiry date: 2028-12-16 | drug substance, drug product |
| Patent 7943621 | 004 | listed patent expiry date: 2028-12-16 | drug substance, drug product |
| Patent 7943621 | 005 | listed patent expiry date: 2028-12-20 | drug substance, drug product |
| Patent 7943621 | 006 | listed patent expiry date: 2028-12-20 | drug substance, drug product |
| Patent 7943621 | 001 | listed patent expiry date: 2029-06-16 | pediatric extension |
| Patent 7943621 | 002 | listed patent expiry date: 2029-06-16 | pediatric extension |
| Patent 7943621 | 003 | listed patent expiry date: 2029-06-16 | pediatric extension |
| Patent 7943621 | 004 | listed patent expiry date: 2029-06-16 | pediatric extension |
| Patent 7943621 | 005 | listed patent expiry date: 2029-06-20 | pediatric extension |
| Patent 7943621 | 006 | listed patent expiry date: 2029-06-20 | pediatric extension |
| Patent RE47350 | 001 | listed patent expiry date: 2029-07-16 | U-1750 |
| Patent RE47350 | 001 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE47350 | 001 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE47350 | 001 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE47350 | 001 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE47350 | 005 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE47350 | 005 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE47350 | 005 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE47350 | 005 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE47350 | 006 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE47350 | 006 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE47350 | 006 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE47350 | 006 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 001 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 001 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 001 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 001 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49110 | 002 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 002 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 002 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 002 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49110 | 003 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 003 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 003 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 004 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 004 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 004 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 005 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 005 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49110 | 005 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 005 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49110 | 006 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49110 | 006 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49110 | 006 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49110 | 006 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49302 | 001 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49302 | 001 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49302 | 001 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49302 | 001 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49302 | 002 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49302 | 002 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49302 | 002 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49302 | 002 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49302 | 003 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49302 | 003 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49302 | 003 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent RE49302 | 003 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49302 | 004 | listed patent expiry date: 2029-07-16 | U-2543 |
| Patent RE49302 | 004 | listed patent expiry date: 2029-07-16 | U-2544 |
| Patent RE49302 | 004 | listed patent expiry date: 2029-07-16 | U-2545 |
| Patent RE49302 | 004 | listed patent expiry date: 2029-07-16 | U-3503 |
| Patent 7737142 | 001 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 001 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2545 |
| Patent 7737142 | 001 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 001 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-1750 |
| Patent 7737142 | 001 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-3503 |
| Patent 7737142 | 002 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2545 |
| Patent 7737142 | 002 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 002 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-1750 |
| Patent 7737142 | 002 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-3503 |
| Patent 7737142 | 002 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 003 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-1750 |
| Patent 7737142 | 003 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 003 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 004 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 004 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-1750 |
| Patent 7737142 | 004 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 005 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 005 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 005 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-3503 |
| Patent 7737142 | 005 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2545 |
| Patent 7737142 | 006 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2543 |
| Patent 7737142 | 006 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2544 |
| Patent 7737142 | 006 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-3503 |
| Patent 7737142 | 006 | listed patent expiry date: 2029-09-17 | drug substance, drug product, U-2545 |
| Patent RE47350 | 001 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE47350 | 005 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE47350 | 006 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 001 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 002 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 003 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 004 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 005 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49110 | 006 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49302 | 001 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49302 | 002 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49302 | 003 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent RE49302 | 004 | listed patent expiry date: 2030-01-16 | pediatric extension |
| Patent 7737142 | 001 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Patent 7737142 | 002 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Patent 7737142 | 003 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Patent 7737142 | 004 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Patent 7737142 | 005 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Patent 7737142 | 006 | listed patent expiry date: 2030-03-17 | pediatric extension |
| Exclusivity M-14 | 001 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity M-14 | 002 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity M-14 | 003 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity M-14 | 004 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity M-14 | 005 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity M-14 | 006 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity NPP | 001 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity NPP | 002 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity NPP | 003 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity NPP | 005 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity NPP | 006 | listed exclusivity date: 2028-12-18 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 004 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 006 | listed exclusivity date: 2029-06-18 | FDA code as listed |
| Exclusivity PED | 006 | listed exclusivity date: 2029-06-18 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: Large-cap biopharma
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.