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Last Updated: December 5, 2020

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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 two branded drugs marketed by Accord Hlthcare, Actavis Inc, Akorn Inc, Am Regent, Amneal Pharms Co, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hong Kong, Jiangsu Hengrui Med, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Sandoz Inc, Slayback Pharma Llc, Sun Pharm Inds Inc, Teva Pharms Usa, West-ward Pharms Int, Zydus Pharms, Hospira, and Hq Spclt Pharma, and is included in twenty-five NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has fifty-two patent family members in thirty-four countries.

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

Recent Clinical Trials for dexmedetomidine hydrochloride

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

SponsorPhase
Ministry of Health, KuwaitPhase 3
Ain Shams UniversityPhase 3
Universiti Sains MalaysiaPhase 2

See all dexmedetomidine hydrochloride clinical trials

Pharmacology for dexmedetomidine hydrochloride
Medical Subject Heading (MeSH) Categories for dexmedetomidine hydrochloride
Paragraph IV (Patent) Challenges for DEXMEDETOMIDINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2015-09-30
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 2013-12-26
PRECEDEX INJECTABLE;INJECTION dexmedetomidine hydrochloride 021038 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
Jiangsu Hengrui Med DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 209065-002 Jun 12, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Hikma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 206407-002 Jan 30, 2020 AP RX No No   Start Trial   Start Trial   Start Trial
Hq Spclt Pharma DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;INTRAVENOUS 206628-001 Oct 21, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205046-001 Apr 26, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013   Start Trial   Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for dexmedetomidine hydrochloride

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