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Last Updated: September 26, 2022

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, Akorn, Am Regent, Amneal Pharms Co, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Piramal Critical, Sandoz Inc, Slayback Pharma Llc, Tagi, Teva Pharms Usa, Zydus Pharms, Hospira, and Hq Spclt Pharma, and is included in twenty-nine NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has seventy-three patent family members in thirty-six countries.

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

Recent Clinical Trials for dexmedetomidine hydrochloride

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

SponsorPhase
Aga Khan University Hospital, PakistanPhase 4
University of MiamiPhase 4
Institut CuriePhase 3

See all dexmedetomidine hydrochloride clinical trials

Pharmacology for dexmedetomidine hydrochloride
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
Actavis Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 204686-001 Oct 17, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Slayback Pharma Llc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 212791-002 Dec 4, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-001 Oct 21, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205272-001 Nov 28, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021038-004 Nov 14, 2014 See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dexmedetomidine hydrochloride

Country Patent Number Title Estimated Expiration
Canada 2806706 FORMULATION DE PREMELANGE DE DEXMEDETOMIDINE (DEXMEDETOMIDINE PREMIX FORMULATION) See Plans and Pricing
Peru 20160681 FORMULACION DE PREMEZCLA DE DEXMEDETOMIDINA See Plans and Pricing
World Intellectual Property Organization (WIPO) 2020236663 See Plans and Pricing
Singapore 11202012772X FILM FORMULATIONS CONTAINING DEXMEDETOMIDINE AND METHODS OF PRODUCING THEM See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dexmedetomidine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0300652 C300117 Netherlands See Plans and Pricing 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
0300652 2003C/005 Belgium See Plans and Pricing PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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