DEXMEDETOMIDINE HYDROCHLORIDE | N021038 | HOSPIRA INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-01577 | 8242158 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2016-01578 | 8338470 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2016-01579 | 8455527 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2016-01580 | 8648106 | IPR | Amneal Pharmaceuticals LLC | Institution Denied | 2016-08-11 | — |
| IPR2017-01054 | 8242158 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| IPR2017-01055 | 8338470 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| IPR2017-01056 | 8455527 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Hospira, Inc. v. Jiangsu Hengrui Medicine Co., Ltd. 4 patentsANDA 209065dexmedetomidine hydrochloride | D. Del. | 2018-02-01 | Terminated 2020-03-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Orion Corporation, Orion Pharma FDA-2023-P-4551 Orion Corporation, Orion Pharma filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare dexmedetomidine hydrochloride injection 100 mcg base/mL in 4 mL and 10 mL single-dose vials suitable for an ANDA, with the refe | Suitability | 2023-10-17 | Open | Orion Corporation |
Attachment 1 - NDA 021038 Detailed Record from the Current Electronic Edition... FDA-2023-P-4551 Orion Corporation, Orion Pharma filed a suitability petition regarding NDA 021038, requesting FDA determination of the suitability of the drug product for ANDA purposes, which relates to the Orange Book listing and unexpired exclusivity protections. | Suitability | 2023-10-17 | Open | Orion Corporation |
Suitability Petition from Orion Corporation, Orion Pharma FDA-2023-P-1847 Orion Corporation, Orion Pharma submitted this suitability petition pursuant to section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Dexmedetomidine Hydrochloride Injection, 100 mcg base/mL in 4 mL and 10 mL single-dose vials suitable for consideration in an ANDA, based on the refere | Suitability | 2023-05-10 | Open | Orion Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.