SELENIOUS ACID | N209379 | AMERICAN REGENT INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| M.D. Fla. | 2025-06-06 | Terminated 2025-06-24 | — | |
| D.N.J. | 2025-05-16 | Terminated 2025-08-05 | — | |
American Regent, Inc. v. Meitheal Pharmaceuticals, Inc. et al 2 patentsANDA 219472Selenious Acid | D. Del. | 2025-02-14 | Terminated 2025-02-26 | — |
AMERICAN REGENT, INC. v. MEITHEAL PHARMACEUTICALS, INC. et al 2 patentsANDA 219472Selenious Acid | D.N.J. | 2025-02-14 | Terminated 2025-02-21 | — |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-12-13 | Terminated 2025-01-03 | — | |
| D.N.J. | 2024-07-16 | Terminated 2024-11-21 | — | |
| D.N.J. | 2024-07-16 | Terminated 2024-11-21 | — | |
| D.N.J. | 2024-07-16 | Terminated 2025-12-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4465 · 8 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act and 21 CFR 314.93 requesting FDA approval to submit an ANDA for Selenious Acid Injection at lower strengths of 400 mcg/10 mL and 8 mcg/2 mL compared to the reference listed drug approved by Americ | Suitability | 2023-10-11 | Granted | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.