PALIPERIDONE | N021999 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2024-P-2272 · 6 docket documents Aurobindo Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether INVEGA (Paliperidone) Extended-Release Tablets 1.5 mg, NDA 021999, manufactured by Janssen Pharmaceuticals Inc, was withdrawn from sale fo | 505(q) | 2024-05-08 | Denied | Aurobindo Pharma USA, Inc. |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0775 · 4 docket documents Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that Janssen's 12 mg strength of INVEGA (paliperidone) Extended-release Tablet | 505(q) | 2013-07-12 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.62
per ea
Lowest NADAC/Unit
$12.37
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458055201INVEGA ER 9 MG TABLET | $18.62 | EA | Brand | $1.24 | 2026-06-17 |
| 50458055001INVEGA ER 3 MG TABLET | $12.45 | EA | Brand | $0.9527 | 2026-01-02 |
| 50458055101INVEGA ER 6 MG TABLET | $12.37 | EA | Brand | $1.09 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.