KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE | N205388 | RAYNER SURGICAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
RAYNER SURGICAL INC. et al v. MANKIND PHARMA LTD. et al 3 patentsANDA 221449phenylephrine and ketorolac | D.N.J. | 2026-06-18 | Active | — |
RAYNER SURGICAL INC. et al v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC et al 3 patentsANDA 220463phenylephrine and ketorolac | D.N.J. | 2026-04-06 | Active | — |
OMEROS CORPORATION v. LUPIN LTD et al 6 patentsANDA 210183phenylephrine hydrochloride and ketorolac tromethamine | D.N.J. | 2017-06-22 | Terminated 2017-10-13 | — |
| D. Del. | 2017-06-22 | Terminated 2018-05-24 | — | |
| D. Del. | 2017-06-21 | Terminated 2018-07-25 | — | |
Omeros Corporation v. Par Sterile Products, LLC et al 3 patentsANDA 208417phenylephrine hydrochloride and ketorolac tromethamine | D. Del. | 2015-09-03 | Terminated 2017-10-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Rayner Surgical Inc. FDA-2024-P-5569 · 23 docket documents Rayner Surgical Inc. filed this citizen petition under 21 CFR section 10.30 and section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA decline to accept or approve any abbreviated new drug application referencing OMIDRIA (phenylephrine and ketorolac injection), 1% / 0.3%, that l | 505(q) | 2024-12-05 | Denied | Rayner Surgical Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.