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Last Updated: November 21, 2024

DEXMEDETOMIDINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for dexmedetomidine hydrochloride and what is the scope of freedom to operate?

Dexmedetomidine hydrochloride is the generic ingredient in three branded drugs marketed by Bioxcel, 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, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hospira, Hq Spclt Pharma, and Somerset, and is included in thirty-two NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has one hundred and twenty-three patent family members in thirty-seven countries.

There are nine drug master file entries for dexmedetomidine hydrochloride. Twenty-nine suppliers are listed for this compound.

Summary for DEXMEDETOMIDINE HYDROCHLORIDE
Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE

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

SponsorPhase
University of Alabama at BirminghamPhase 1
Boston Medical CenterPhase 4
Children's Mercy Hospital Kansas CityPhase 4

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 201072-001 Sep 18, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fresenius Kabi Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 208129-001 Nov 29, 2018 AP RX No 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
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-001 Apr 5, 2022 RX Yes Yes ⤷  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

Expired US Patents for DEXMEDETOMIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ⤷  Sign Up ⤷  Sign Up
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DEXMEDETOMIDINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Taiwan 201332546 Dexmedetomidine premix formulation ⤷  Sign Up
Canada 3145388 REGIMES DE TRAITEMENT NON SEDATIFS A BASE DE DEXMEDETOMIDINE (NON-SEDATING DEXMEDETOMIDINE TREATMENT REGIMENS) ⤷  Sign Up
Japan 7008153 ⤷  Sign Up
South Africa 202006636 USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION ⤷  Sign Up
China 114375191 非镇静的右美托咪定治疗方案 (Non-sedative dexmedetomidine treatment regimen) ⤷  Sign Up
China 107802624 ⤷  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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