BREXPIPRAZOLE | N205422 | OTSUKA PHARMACEUTICAL CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-05-02 | Terminated 2022-08-31 | — | |
| D. Del. | 2022-02-18 | Terminated 2022-04-27 | — | |
| D. Del. | 2021-04-26 | Terminated 2022-08-31 | — | |
| D. Del. | 2021-03-01 | Terminated 2022-07-12 | — | |
| D. Del. | 2020-12-23 | Terminated 2022-08-24 | — | |
| D. Del. | 2020-11-24 | Terminated 2022-10-20 | — | |
| D. Del. | 2020-11-23 | Terminated 2022-09-07 | — | |
| D. Del. | 2020-11-13 | Terminated 2022-05-11 | — | |
| D. Del. | 2020-11-06 | Terminated 2022-09-09 | — | |
Otsuka Pharmaceutical Co., Ltd. et al v. MSN Laboratories Private Ltd. et al 6 patentsANDA 213740brexpiprazole | D. Del. | 2020-10-23 | Terminated 2022-10-14 | — |
| D. Del. | 2020-10-23 | Terminated 2022-04-27 | — | |
| D. Del. | 2020-10-08 | Terminated 2022-05-19 | — | |
Otsuka Pharmaceutical Co., Ltd. et al v. Ajanta Pharma Ltd. 5 patentsANDA 213718brexpiprazole | D. Del. | 2020-10-01 | Terminated 2022-07-20 | — |
Otsuka Pharmaceutical Co., Ltd. et al v. Optimus Pharma Pvt. Ltd. 5 patentsANDA 213758brexpiprazole | D. Del. | 2020-10-01 | Terminated 2022-09-21 | — |
Otsuka Pharmaceutical Co., Ltd. et al v. Amneal Pharmaceuticals LLC et al 6 patentsANDA 213562brexpiprazole | D. Del. | 2020-09-25 | Terminated 2022-08-17 | — |
| D. Del. | 2020-09-25 | Terminated 2022-02-03 | — | |
| D. Del. | 2020-09-25 | Terminated 2021-10-20 | — | |
| D. Del. | 2020-09-25 | Terminated 2022-07-29 | — | |
| D. Del. | 2020-09-24 | Terminated 2022-06-28 | — | |
| D. Del. | 2019-11-01 | Terminated 2022-08-31 | — | |
| D. Del. | 2019-10-31 | Terminated 2022-07-12 | — | |
| D. Del. | 2019-10-25 | Terminated 2022-08-24 | — | |
| D. Del. | 2019-10-23 | Terminated 2022-05-19 | — | |
| D. Del. | 2019-10-23 | Terminated 2022-10-26 | — | |
| D. Del. | 2019-10-23 | Terminated 2022-09-21 | — | |
| D. Del. | 2019-10-23 | Terminated 2022-10-14 | — | |
| D. Del. | 2019-10-18 | Terminated 2022-07-29 | — | |
| D. Del. | 2019-10-18 | Terminated 2022-02-03 | — | |
| D. Del. | 2019-10-17 | Terminated 2021-10-20 | — | |
| D. Del. | 2019-10-16 | Terminated 2022-09-07 | — | |
| D. Del. | 2019-10-16 | Terminated 2022-06-28 | — | |
| D. Del. | 2019-10-15 | Terminated 2022-08-17 | — | |
| D. Del. | 2019-10-15 | Terminated 2022-09-09 | — | |
| D. Del. | 2019-10-15 | Terminated 2022-04-27 | — | |
| D. Del. | 2019-10-15 | Terminated 2022-05-11 | — | |
Otsuka Pharmaceutical Co., Ltd. et al v. Ajanta Pharma Ltd. 5 patentsANDA 213718brexpiprazole | D. Del. | 2019-10-11 | Terminated 2022-07-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
Highest NADAC/Unit
$49.60
per ea
Lowest NADAC/Unit
$49.50
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59148003713REXULTI 1 MG TABLET | $49.60 | EA | Brand | — | 2026-06-17 |
| 59148004013REXULTI 4 MG TABLET | $49.60 | EA | Brand | — | 2026-06-17 |
| 59148003813REXULTI 2 MG TABLET | $49.58 | EA | Brand | — | 2026-06-17 |
| 59148003913REXULTI 3 MG TABLET | $49.58 | EA | Brand | — | 2026-06-17 |
| 59148003513REXULTI 0.25 MG TABLET | $49.52 | EA | Brand | — | 2026-06-17 |
| 59148003613REXULTI 0.5 MG TABLET | $49.50 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE48059 | Dec 23, 2028PED: Jun 23, 2029 | PED | Yes | — | — | — |
| 7888362 | Apr 12, 2026PED: Oct 12, 2026 | PED | Yes | — | — | Delisted |
| 8349840 | Apr 12, 2026PED: Oct 12, 2026 | PED | — | Yes | — | |
| 8618109 | Apr 12, 2026PED: Oct 12, 2026 | PED | — | — | — | |
| 9839637 | Apr 12, 2026PED: Oct 12, 2026 | PED | — | Yes | — | |
| 10307419 | Oct 12, 2032PED: Apr 12, 2033 | PED | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| I-913 | May 10, 2026 | Expired |
| M-14 | May 8, 2027 | < 1 year |
| M-315 | May 9, 2028 | Active |
| PED | Nov 10, 2026 | < 1 year |
| PED | Nov 8, 2027 | Active |
| I-913*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Nov 10, 2026 | < 1 year |
| M-14*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Nov 8, 2027 | Active |
Otsuka's REXULTI (brexpiprazole) NDA 205422 gained pediatric exclusivity (PED) with expiration in Nov 2026.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
REXULTI (brexpiprazole) received pediatric exclusivity expiring Nov 2026 under application 205422.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
Otsuka received pediatric exclusivity (M-14*PED) for REXULTI (brexpiprazole), extending regulatory exclusivity to Nov 2027.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027
Otsuka's REXULTI (brexpiprazole) NDA 205422 supplement 003 received pediatric exclusivity (M-14*PED) with expiration Nov 2027.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027
Otsuka gained pediatric exclusivity for REXULTI (brexpiprazole) under NDA 205422, extending regulatory exclusivity to Nov 2027.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027
Otsuka added pediatric exclusivity for REXULTI (brexpiprazole) expiring Nov 2026 to NDA 205422.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
Otsuka's REXULTI (brexpiprazole) NDA 205422 received pediatric exclusivity designation I-913*PED with expiration Nov 2026.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
Otsuka's REXULTI (brexpiprazole) gains pediatric exclusivity (PED) with expiration Nov 2027 under NDA 205422.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027
Otsuka's REXULTI (brexpiprazole) gained pediatric exclusivity with a 6-month extension expiring Nov 2027, based on a completed pediatric study under the FDA's Pediatric Exclusivity Program.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027
REXULTI (brexpiprazole) gained pediatric exclusivity (PED) expiring Nov 2026 under NDA 205422, supplement 003.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
REXULTI (brexpiprazole) gained pediatric exclusivity with expiration Nov 2026, extending regulatory protection for the supplemental application.
New: REXULTI (BREXPIPRAZOLE) — exclusivity I-913*PED exp 11/10/2026
REXULTI (brexpiprazole) gained pediatric exclusivity with a Nov 2027 expiration date.
New: REXULTI (BREXPIPRAZOLE) — exclusivity M-14*PED exp 11/08/2027