FDA Orange Book · active-ingredient family
Cariprazine hydrochloride
Cariprazine hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
1
Brand (NDA)
3
Generics (ANDA)
10
Listed patents
22
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VRAYLARRLD×6 | ABBVIE | NDA 204370 | — | Dec 18, 2025 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARIPRAZINE HYDROCHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 213982 | — | Dec 16, 2025 | |
| CARIPRAZINE HYDROCHLORIDE×4 | SUN PHARM | ANDA 213932 | — | Sep 30, 2022 | |
| CARIPRAZINE HYDROCHLORIDE×4 | ZYDUS | ANDA 213984 | — | Sep 09, 2022 |
Marketing exclusivity (22)
- 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
- 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
- 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
- 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
- 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
- M-14New use / labeling-change exclusivity (3 years)
Dec 18, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 18, 2029
in 3 yr 1 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7943621 | Dec 20, 2028 | in 2 yr 7 mo | SubstanceProduct |
| 7943621*PED | Jun 20, 2029 | in 3 yr 1 mo | |
| RE49110 | Jul 16, 2029 | in 3 yr 1 mo | U-2543 |
| RE47350 | Jul 16, 2029 | in 3 yr 1 mo | U-2543 |
| RE49302 | Jul 16, 2029 | in 3 yr 1 mo | U-2543 |
| 7737142 | Sep 17, 2029 | in 3 yr 4 mo | SubstanceProductU-2543 |
| RE49110*PED | Jan 16, 2030 | in 3 yr 8 mo | |
| RE47350*PED | Jan 16, 2030 | in 3 yr 8 mo | |
| RE49302*PED | Jan 16, 2030 | in 3 yr 8 mo | |
| 7737142*PED | Mar 17, 2030 | in 3 yr 10 mo |
Cariprazine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
