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Last Updated: July 13, 2024

DEXMEDETOMIDINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Dexmedetomidine Hydrochloride, and what generic alternatives are available?

Dexmedetomidine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Piramal Critical, Rising, Sandoz, Slayback Pharma Llc, Tagi, Teva Pharms Usa, Zydus Pharms, and Hq Spclt Pharma. and is included in twenty-nine NDAs. There are two patents protecting this drug.

This drug has five patent family members in five countries.

The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dexmedetomidine Hydrochloride

A generic version of DEXMEDETOMIDINE HYDROCHLORIDE was approved as dexmedetomidine hydrochloride by ENDO OPERATIONS on August 18th, 2014.

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Drug patent expirations by year for DEXMEDETOMIDINE HYDROCHLORIDE
Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical CenterPhase 4
Children's Mercy Hospital Kansas CityPhase 4
University Hospital "Sestre Milosrdnice"N/A

See all DEXMEDETOMIDINE HYDROCHLORIDE clinical trials

Pharmacology for DEXMEDETOMIDINE HYDROCHLORIDE
Drug ClassCentral alpha-2 Adrenergic Agonist
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for DEXMEDETOMIDINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DEXMEDETOMIDINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DEXMEDETOMIDINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRECEDEX Injection dexmedetomidine hydrochloride 4 mcg/mL, 20 mL vials 021038 1 2015-09-30
PRECEDEX Injection dexmedetomidine hydrochloride 4 mcg/mL, 50 mL and 100 mL vials 021038 1 2013-12-26
PRECEDEX Injection dexmedetomidine hydrochloride 100 mcg/mL 021038 1 2009-04-08

US Patents and Regulatory Information for DEXMEDETOMIDINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE is protected by two US patents.

Patents protecting DEXMEDETOMIDINE HYDROCHLORIDE

Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Slayback Pharma Llc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 212791-002 Dec 4, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Milla Pharms DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 217308-002 Jun 7, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-003 Jun 22, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Pharms Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205272-001 Nov 28, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-001 Oct 21, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 206407-001 Jan 30, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Institutional DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202881-001 Aug 18, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DEXMEDETOMIDINE HYDROCHLORIDE

See the table below for patents covering DEXMEDETOMIDINE HYDROCHLORIDE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3429574 SOLUTION DE DEXMÉDÉTOMIDINE PRÉMÉLANGÉE, PRÊTE À L'EMPLOI, STÉRILISABLE À CHAUD PRÉSENTÉE DANS UN CONTENANT EN PLASTIQUE SOUPLE (HEAT STERILIZEABLE, PREMIXED, READY TO USE DEXMEDETOMIDINE SOLUTION PACKAGED IN A FLEXIBLE PLASTIC CONTAINER) ⤷  Sign Up
Australia 2016403510 Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017184188 ⤷  Sign Up
Argentina 108806 SOLUCIÓN DE DEXMEDETOMIDINA LISTA PARA EL USO, PREMEZCLADA, ESTERILIZABLE POR CALOR, ENVASADA EN UN RECIPIENTE DE PLÁSTICO FLEXIBLE ⤷  Sign Up
South Africa 201807466 HEAT STERILIZEABLE, PREMIXED, READY TO USE DEXMEDETOMIDINE SOLUTION PACKAGED IN A FLEXIBLE PLASTIC CONTAINER ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DEXMEDETOMIDINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0300652 2003C/005 Belgium ⤷  Sign Up PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
0300652 C300117 Netherlands ⤷  Sign Up PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.