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Last Updated: January 28, 2023

Details for Patent: 8,338,470


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Which drugs does patent 8,338,470 protect, and when does it expire?

Patent 8,338,470 protects PRECEDEX and is included in one NDA.

Protection for PRECEDEX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-one patent family members in thirty-five countries.

Summary for Patent: 8,338,470
Title:Dexmedetomidine premix formulation
Abstract: The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
Inventor(s): Roychowdhury; Priyanka (San Rafael, CA), Cedergren; Robert A. (Libertyville, IL)
Assignee: Hospira, Inc. (Lake Forest, IL)
Application Number:13/541,524
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,338,470
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Drugs Protected by US Patent 8,338,470

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,338,470

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 089673 See Plans and Pricing
Argentina 117001 See Plans and Pricing
Australia 2013201069 See Plans and Pricing
Brazil 112013008005 See Plans and Pricing
Canada 2806706 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Merck
Express Scripts
Mallinckrodt
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.