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Last Updated: February 25, 2024

Dexmedetomidine hydrochloride - Generic Drug Details


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What are the generic sources for dexmedetomidine hydrochloride and what is the scope of patent protection?

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, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Piramal Critical, Rising, Sandoz, Slayback Pharma Llc, Tagi, Teva Pharms Usa, Zydus Pharms, Hospira, and Hq Spclt Pharma, and is included in thirty-one NDAs. There are sixteen 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 three patent family members in thirty-six countries.

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

Recent Clinical Trials for dexmedetomidine hydrochloride

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
Kafrelsheikh UniversityPhase 2
Kasr El Aini HospitalN/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
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-002 Apr 5, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bioxcel IGALMI dexmedetomidine hydrochloride FILM;BUCCAL, SUBLINGUAL 215390-001 Apr 5, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021038-004 Nov 14, 2014 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ⤷  Try a Trial ⤷  Try a Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dexmedetomidine hydrochloride

Country Patent Number Title Estimated Expiration
Colombia 6680698 Formulación de premezcla de dexmedetomidina ⤷  Try a Trial
Chile 2013000815 Composicion farmaceutica liquida de adm inistracion parenteral que comprende dexmedetomidina o una sal de la misma en una concentracion de 0,005 a 50 µg/ml y adicionalmente comprende cloruro de sodio en una concentracion de 0,01 a 2 % en peso, dispuesta dentro de un contenedor de vidrio sellado. ⤷  Try a Trial
Taiwan 202019388 Film formulations containing DEXMEDETOMIDINE and methods of producing them ⤷  Try a Trial
Israel 224867 פורמולציה שמעורבב מראש דקסמדטומידין (Dexmedetomidine premix formulation) ⤷  Try a Trial
>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 ⤷  Try a Trial PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
0300652 C300117 Netherlands ⤷  Try a 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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