DEXMEDETOMIDINE HYDROCHLORIDE | N021038 | HOSPIRA INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2017-01054 | 8242158 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| IPR2016-01577 | 8242158 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2017-01055 | 8338470 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| IPR2016-01578 | 8338470 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2017-01056 | 8455527 | IPR | Fresenius Kabi USA, LLC | Institution Denied | 2017-03-08 | — |
| IPR2016-01579 | 8455527 | IPR | Amneal Pharmaceuticals LLC | Terminated-Settled | 2016-08-10 | — |
| IPR2016-01580 | 8648106 | IPR | Amneal Pharmaceuticals LLC | Institution Denied | 2016-08-11 | — |
| 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 | — |
| 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 · 7 docket documents 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 | Granted | Orion Corporation, Orion Pharma |
Suitability Petition from Orion Corporation, Orion Pharma FDA-2023-P-1847 · 3 docket documents 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mL and 10 mL single-dose vials suitable for consideration in an ANDA, based on the refere | Suitability | 2023-05-10 | Withdrawn | Orion Corporation, Orion Pharma |
Foley & Lardner LLP - Citizen Petition FDA-2012-P-1147 · 3 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) on behalf of a client seeking FDA approval to submit an Abbreviated New Drug Application for Dexmedetomidine Hydrochloride Injection in a 400 mcg/4 mL vial presentation, with PRECEDEX (Dexmedetomidine Hydrochloride) Injection | Other | 2012-11-21 | Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0381 · 3 docket documents Lachman Consultant Services, Inc. filed a citizen petition requesting that the FDA take action regarding dexmedetomidine hydrochloride, the active ingredient in the reference listed drug Precedex (NDA 21038), an injectable sedative product. The petition seeks FDA review of the Orange Book listing an | Other | 2011-05-25 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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