Orange Book product · Brand (NDA)
VRAYLAR
CARIPRAZINE HYDROCHLORIDE
At a glance
Dec 18, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2025
6 mo ago
Today
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
Patent 7943621 expires
Listed drug substance patent expiration.
Dec 20, 2028
in 2 yr 7 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr 1 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr 1 mo
Patent 7943621*PED expires
Listed listed patent expiration.
Jun 20, 2029
in 3 yr 1 mo
Patent RE47350 expires
Listed method-of-use patent (U-2543) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE47350 expires
Listed method-of-use patent (U-2544) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE47350 expires
Listed method-of-use patent (U-3503) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE47350 expires
Listed method-of-use patent (U-2545) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE49110 expires
Listed method-of-use patent (U-2543) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE49110 expires
Listed method-of-use patent (U-2544) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE49110 expires
Listed method-of-use patent (U-2545) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent RE49110 expires
Listed method-of-use patent (U-3503) expiration.
Jul 16, 2029
in 3 yr 1 mo
Patent 7737142 expires
Listed drug substance patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 7737142 expires
Listed drug substance patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 7737142 expires
Listed drug substance patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent 7737142 expires
Listed drug substance patent expiration.
Sep 17, 2029
in 3 yr 4 mo
Patent RE47350*PED expires
Listed listed patent expiration.
Jan 16, 2030
in 3 yr 8 mo
Patent RE49110*PED expires
Listed listed patent expiration.
Jan 16, 2030
in 3 yr 8 mo
Patent 7737142*PED expires
Listed listed patent expiration.
Mar 17, 2030
in 3 yr 10 mo
Pharmaceutical detail
Active ingredient
CARIPRAZINE HYDROCHLORIDE
Strength
EQ 0.5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 204370
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr 1 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr 1 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7943621 | Dec 20, 2028 | in 2 yr 7 mo | SubstanceProduct |
| 7943621*PED | Jun 20, 2029 | in 3 yr 1 mo | |
| RE47350 | Jul 16, 2029 | in 3 yr 1 mo | U-2543 |
| RE47350 | Jul 16, 2029 | in 3 yr 1 mo | U-2544 |
| RE47350 | Jul 16, 2029 | in 3 yr 1 mo | U-3503 |
| RE47350 | Jul 16, 2029 | in 3 yr 1 mo | U-2545 |
| RE49110 | Jul 16, 2029 | in 3 yr 1 mo | U-2543 |
| RE49110 | Jul 16, 2029 | in 3 yr 1 mo | U-2544 |
| RE49110 | Jul 16, 2029 | in 3 yr 1 mo | U-2545 |
| RE49110 | Jul 16, 2029 | in 3 yr 1 mo | U-3503 |
| 7737142 | Sep 17, 2029 | in 3 yr 4 mo | SubstanceProductU-2543 |
| 7737142 | Sep 17, 2029 | in 3 yr 4 mo | SubstanceProductU-2544 |
| 7737142 | Sep 17, 2029 | in 3 yr 4 mo | SubstanceProductU-3503 |
| 7737142 | Sep 17, 2029 | in 3 yr 4 mo | SubstanceProductU-2545 |
| RE47350*PED | Jan 16, 2030 | in 3 yr 8 mo | |
| RE49110*PED | Jan 16, 2030 | in 3 yr 8 mo | |
| 7737142*PED | Mar 17, 2030 | in 3 yr 10 mo |
