DEXMEDETOMIDINE HYDROCHLORIDE Drug Patent Profile

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, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, Hq Spclt Pharma, and Somerset. and is included in thirty 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 18^th, 2014.

Summary for DEXMEDETOMIDINE HYDROCHLORIDE

International Patents:	5
US Patents:	2
Applicants:	26
NDAs:	30
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1,344
Patent Applications:	222
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXMEDETOMIDINE HYDROCHLORIDE
What excipients (inactive ingredients) are in DEXMEDETOMIDINE HYDROCHLORIDE?	DEXMEDETOMIDINE HYDROCHLORIDE excipients list
DailyMed Link:	DEXMEDETOMIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Boston Medical Center	Phase 4
Children's Mercy Hospital Kansas City	Phase 4

See all DEXMEDETOMIDINE HYDROCHLORIDE clinical trials

Pharmacology for DEXMEDETOMIDINE HYDROCHLORIDE

Drug Class	Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists
Physiological Effect	General Anesthesia

Medical Subject Heading (MeSH) Categories for DEXMEDETOMIDINE HYDROCHLORIDE

Adrenergic alpha-2 Receptor Agonists

Analgesics, Non-Narcotic

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for DEXMEDETOMIDINE HYDROCHLORIDE

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

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 and one FDA Regulatory Exclusivity.

Patents protecting DEXMEDETOMIDINE HYDROCHLORIDE

FDA Regulatory Exclusivity protecting DEXMEDETOMIDINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tagi	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	212857-003	Nov 23, 2020	AP	RX	No	No
Milla Pharms	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	217308-002	Jun 7, 2023	AP	RX	No	No
Hq Spclt Pharma	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	SOLUTION;INTRAVENOUS	206628-003	Jun 22, 2018		RX	Yes	No			Y
Wilshire Pharms Inc	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	212791-002	Dec 4, 2019	AP	RX	No	No
Hq Spclt Pharma	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	SOLUTION;INTRAVENOUS	206628-001	Oct 21, 2015	AP	RX	Yes	No
Hikma	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	206407-001	Jan 30, 2020	AP	RX	No	No
Mylan Institutional	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	202881-001	Aug 18, 2014	AP	RX	No	No

International Patents for DEXMEDETOMIDINE HYDROCHLORIDE

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

Country	Patent Number	Title	Estimated Expiration
South Africa	201807466	HEAT STERILIZEABLE, PREMIXED, READY TO USE DEXMEDETOMIDINE SOLUTION PACKAGED IN A FLEXIBLE PLASTIC CONTAINER
Australia	2016403510	Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
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)
Argentina	108806	SOLUCIÓN DE DEXMEDETOMIDINA LISTA PARA EL USO, PREMEZCLADA, ESTERILIZABLE POR CALOR, ENVASADA EN UN RECIPIENTE DE PLÁSTICO FLEXIBLE
World Intellectual Property Organization (WIPO)	2017184188

Supplementary Protection Certificates for DEXMEDETOMIDINE HYDROCHLORIDE

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