PALIPERIDONE PALMITATE | N022264 | JANSSEN PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-00440 | 9439906 | IPR | Mylan Laboratories Ltd. et al. | Institution Denied | 2020-02-07 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
JANSSEN PHARMACEUTICALS, INC et al v. EUGIA PHARMA SPECIALTIES LTD. et al 1 patentANDA 221305paliperidone palmitate extended-release injectable suspension | D.N.J. | 2026-03-25 | Active | — |
Janssen Pharmaceuticals, Inc. et al v. Sun Pharmaceutical Industries Ltd. et al 1 patentANDA 217818paliperidone palmitate | D. Del. | 2025-07-10 | Terminated 2025-10-28 | — |
JANSSEN PHARMACEUTICALS, INC et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 1 patentANDA 217818paliperidone palmitate extended-release injectable suspension | D.N.J. | 2025-07-09 | Terminated 2025-12-29 | — |
JANSSEN PHARMACEUTICALS, INC. et al v. ACCORD HEALTHCARE, INC. 1 patentANDA 216674paliperidone palmitate extended-release injectable suspension | D.N.J. | 2022-02-16 | Terminated 2022-07-13 | — |
Janssen Pharmaceuticals, Inc., et al. v. Tolmar, Inc. 1 patentANDA 211995paliperidone palmitate extended-release injectable suspension | D. Del. | 2021-12-21 | Terminated 2024-03-13 | — |
| D. Del. | 2019-12-20 | Terminated 2020-03-02 | — | |
JANSSEN PHARMACEUTICALS, INC et al v. PHARMASCIENCE INC. et al 1 patentANDA 210397paliperidone palmitate | D.N.J. | 2019-12-19 | Terminated 2022-07-13 | — |
Janssen Pharmaceuticals, Inc. et al v. Mylan Laboratories Limited et al 1 patentANDA 213124paliperidone palmitate extended-release injectable suspension | D. Del. | 2019-08-09 | Terminated 2019-09-27 | — |
JANSSEN PHARMACEUTICALS, INC. et al v. MYLAN LABORATORIES LIMITED et al 1 patentANDA 213124paliperidone palmitate | D.N.J. | 2019-08-08 | Terminated 2021-12-22 | — |
JANSSEN PHARMACEUTICALS, INC. et al v. TEVA PHARMACEUTICALS USA, INC. et al 1 patentANDA 211149paliperidone palmitate extended release injectable suspension | D.N.J. | 2018-01-17 | Terminated 2021-11-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. on behalf of Luye Innomi... FDA-2025-P-3542 · 3 docket documents The law firm Hyman, Phelps & McNamara, P.C., on behalf of Luye Innomind Pharma Shijiazhuang Co., Ltd., petitioned the FDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to assign a therapeutic equivalence evaluation code of "AB" to five strengths of ERZOFRI (paliperidone palmita | Other | 2025-09-04 | Open | Luye Innomind Pharma Shijiazhuang Co., Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2344.28
per ml
Lowest NADAC/Unit
$2339.07
per ml
Brand NDCs
5
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458056201INVEGA SUSTENNA 117 MG/0.75 ML | $2344.28 | ML | Brand | — | 2026-06-17 |
| 50458056101INVEGA SUSTENNA 78 MG/0.5 ML | $2340.44 | ML | Brand | — | 2026-06-17 |
| 50458056401INVEGA SUSTENNA 234 MG/1.5 ML | $2339.81 | ML | Brand | — | 2026-06-17 |
| 50458056301INVEGA SUSTENNA 156 MG/ML SYRG | $2339.52 | ML | Brand | — | 2026-06-17 |
| 50458056001INVEGA SUSTENNA 39 MG/0.25 ML | $2339.07 | ML | Brand | — | 2026-01-02 |
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 |
|---|---|---|---|---|---|---|
| 9439906 | Jan 26, 2031 | — | — | — | — |