Pharsight

Application	Filing Date	Opposition Party	Legal Status

EP12823234A	2019-01-09	Fresenius Kabi Deutschland GmbH	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8242158	March, 2017	Terminated-Denied	Hospira, Inc.	Fresenius Kabi USA, LLC
US8338470	March, 2017	Terminated-Denied	Hospira, Inc.	Fresenius Kabi USA, LLC
US8455527	March, 2017	Terminated-Denied	Hospira, Inc.	Fresenius Kabi USA, LLC
US8648106	August, 2016	Terminated-Denied	Hospira, Inc.	Amneal Pharmaceuticals LLC
US8242158	August, 2016	Terminated-Settled	Hospira, Inc.	Amneal Pharmaceuticals LLC
US8338470	August, 2016	Terminated-Settled	Hospira, Inc.	Amneal Pharmaceuticals LLC
US8455527	August, 2016	Terminated-Settled	Hospira, Inc.	Amneal Pharmaceuticals LLC

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8338470	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US8455527	HOSPIRA	Methods of treatment using a dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US8648106	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US9616049	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US8242158	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US10016396	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US9320712	HOSPIRA	Dexmedetomidine premix formulation	Jan, 2032 (8 years from now)
US9616049 (Pediatric)	HOSPIRA	Dexmedetomidine premix formulation	Jul, 2032 (8 years from now)
US8648106 (Pediatric)	HOSPIRA	Dexmedetomidine premix formulation	Jul, 2032 (8 years from now)
US8242158 (Pediatric)	HOSPIRA	Dexmedetomidine premix formulation	Jul, 2032 (8 years from now)
US8455527 (Pediatric)	HOSPIRA	Methods of treatment using a dexmedetomidine premix formulation	Jul, 2032 (8 years from now)
US9320712 (Pediatric)	HOSPIRA	Dexmedetomidine premix formulation	Jul, 2032 (8 years from now)
US8338470 (Pediatric)	HOSPIRA	Dexmedetomidine premix formulation	Jul, 2032 (8 years from now)

Precedex is owned by Hospira.

Precedex contains Dexmedetomidine Hydrochloride.

Precedex has a total of 13 drug patents out of which 0 drug patents have expired.

Precedex was authorised for market use on 17 December, 1999.

Precedex is available in injectable;injection dosage forms.

Precedex can be used as use for sedation.

The generics of Precedex are possible to be released after 04 July, 2032.

Drug Exclusivity	Drug Exclusivity Expiration
New Patient Population (NPP)	Dec 16, 2025

Market Authorisation Date: 17 December, 1999

Treatment: Use for sedation

Dosage: INJECTABLE;INJECTION

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mcg/mL	08 Apr, 2009	1	14 Jun, 2016	31 Mar, 2019	Eligible
4 mcg/mL, 50 mL and 100 mL vials	26 Dec, 2013	1	30 Jan, 2020	04 Jan, 2032	Extinguished
4 mcg/mL, 20 mL vials	30 Sep, 2015	1	29 Nov, 2018	04 Jan, 2032	Eligible

PRECEDEX family patents

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