FDA Orange Book
Is there a generic for Vraylar?
Vraylar contains cariprazine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vraylar (cariprazine). The Orange Book shows its last listed patent expires March 17, 2030 and its last listed exclusivity ends June 18, 2029.
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Vraylar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 1.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 3MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 4.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 6MG BASE | Marketed (Rx) | None | 0 | None |
NDA 204370, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vraylar patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7943621 | December 20, 2028 | Drug substance, Drug product | None | 204370 |
| 7943621*PED | June 20, 2029 | Method of use | None | 204370 |
| RE49110 | July 16, 2029 | Method of use | U-2543 | 204370 |
| RE49110 | July 16, 2029 | Method of use | U-2544 | 204370 |
| RE49110 | July 16, 2029 | Method of use | U-2545 | 204370 |
| RE49110 | July 16, 2029 | Method of use | U-3503 | 204370 |
| RE47350 | July 16, 2029 | Method of use | U-2543 | 204370 |
| RE47350 | July 16, 2029 | Method of use | U-2544 | 204370 |
| RE47350 | July 16, 2029 | Method of use | U-3503 | 204370 |
| RE47350 | July 16, 2029 | Method of use | U-2545 | 204370 |
| RE47350 | July 16, 2029 | Method of use | U-1750 | 204370 |
| RE49302 | July 16, 2029 | Method of use | U-2543 | 204370 |
| RE49302 | July 16, 2029 | Method of use | U-3503 | 204370 |
| RE49302 | July 16, 2029 | Method of use | U-2544 | 204370 |
| RE49302 | July 16, 2029 | Method of use | U-2545 | 204370 |
| 7737142 | September 17, 2029 | Drug substance, Drug product | U-2543 | 204370 |
| 7737142 | September 17, 2029 | Drug substance, Drug product | U-2544 | 204370 |
| 7737142 | September 17, 2029 | Drug substance, Drug product | U-3503 | 204370 |
| 7737142 | September 17, 2029 | Drug substance, Drug product | U-2545 | 204370 |
| 7737142 | September 17, 2029 | Drug substance, Drug product | U-1750 | 204370 |
| RE49110*PED | January 16, 2030 | Method of use | None | 204370 |
| RE47350*PED | January 16, 2030 | Method of use | None | 204370 |
| RE49302*PED | January 16, 2030 | Method of use | None | 204370 |
| 7737142*PED | March 17, 2030 | Method of use | None | 204370 |
Vraylar exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | December 18, 2028 | 204370 |
| NPP | New patient population | December 18, 2028 | 204370 |
| PED | Pediatric exclusivity | June 18, 2029 | 204370 |
Vraylar NDC codes
Questions
Is there a generic for Vraylar?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vraylar (cariprazine). The Orange Book shows its last listed patent expires March 17, 2030 and its last listed exclusivity ends June 18, 2029.
What is the generic name for Vraylar?
The active ingredient in Vraylar is cariprazine, per the FDA Orange Book.
When does the Vraylar patent expire?
The last patent listed for Vraylar in the Orange Book expires March 17, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.