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:	242
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.

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	9,649,296		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
World Intellectual Property Organization (WIPO)	2017184188
Argentina	108806	SOLUCIÓN DE DEXMEDETOMIDINA LISTA PARA EL USO, PREMEZCLADA, ESTERILIZABLE POR CALOR, ENVASADA EN UN RECIPIENTE DE PLÁSTICO FLEXIBLE
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)
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

Supplementary Protection Certificates for DEXMEDETOMIDINE HYDROCHLORIDE

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

DEXMEDETOMIDINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexmedetomidine Hydrochloride

Introduction

Dexmedetomidine hydrochloride, marketed under names such as Precedex, Dexdor, and Igalmi, is a highly selective α-2 adrenoreceptor agonist used primarily as a sedative and analgesic. The market for this drug is experiencing significant growth, driven by several key factors.

Market Size and Forecast

The global dexmedetomidine market has been valued at USD 1.8 billion in 2023 and is projected to reach USD 3.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.7% from 2024 to 2031[3].

Another projection indicates that the market could reach USD 4.6 billion by 2032, with a CAGR of 14.59% during the forecast period[4].

Market Segmentation

The dexmedetomidine market is segmented based on several criteria:

Application

• Intensive Care Unit (ICU) Sedation: Dexmedetomidine is widely used in ICUs for sedating mechanically ventilated adults, reducing time to extubation and ICU stay[2][3].
• Procedural Sedation: It is also used in procedural sedation, offering benefits such as improved hemodynamic stability and less respiratory depression[3].
• Operating Rooms and Ambulatory Care: The drug is utilized in surgical settings and ambulatory care, contributing to its growing market share[3].

Product

• Injectable Forms: Available in concentrations such as 100mcg/ml and 200mcg/2ml, these are the most common forms of administration[1].
• Intranasal, Intravenous, and Other Routes: Dexmedetomidine can also be administered via intranasal, intravenous, sublingual, and buccal routes, expanding its application scope[2].

Geographical Regions

The market is analyzed across regions including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region presents unique market dynamics and growth opportunities[1][3].

Drivers of Market Growth

Several factors are driving the growth of the dexmedetomidine market:

Increasing Use in ICUs and Surgical Settings

The efficacy of dexmedetomidine as a sedative and analgesic in critical care and surgical procedures is a significant driver. It reduces ICU costs by shortening the time to extubation and ICU stay[2][3].

Preference Over Traditional Sedatives

Dexmedetomidine offers improved hemodynamic stability and less respiratory depression compared to traditional sedatives, making it a preferred choice in critical care settings[3].

Innovations in Drug Formulations

Advancements in pharmaceutical development and the introduction of new delivery systems are enhancing the market's growth trajectory[3].

Ongoing Clinical Research

Continuous research and clinical trials highlighting the benefits and safety profile of dexmedetomidine are further boosting market expansion[3].

Market Challenges and Restraints

Despite the growth, there are some challenges and restraints to consider:

Side Effects

Dexmedetomidine can cause side effects such as bradycardia and hypotension, particularly at higher doses. These side effects need careful management[2].

Hepatic Impairment

The drug is metabolized by the liver, so it should be used cautiously in patients with liver disease or hepatic impairment[2].

Economic Factors

While dexmedetomidine is associated with lower ICU costs, its overall cost-effectiveness can vary depending on the healthcare system and region[2].

Key Players and Market Competition

The market for dexmedetomidine includes both established and emerging players. Companies like Orion Pharma, which developed and markets dexmedetomidine under names like Dexdor and Precedex, play a significant role. The report provides detailed profiles of these companies, including their market entry year and various market-related factors[1].

Economic Impact

From an economic perspective, dexmedetomidine is associated with lower ICU costs due to its ability to reduce the time to extubation and ICU stay. This economic benefit is a crucial factor in its adoption and market growth[2].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics of dexmedetomidine is essential for its effective use. It exhibits linear pharmacokinetics with a rapid distribution half-life and a terminal elimination half-life of approximately 2-4 hours. The drug is metabolized by the liver and excreted primarily in the urine[2].

Clinical Benefits

Dexmedetomidine has several clinical benefits that contribute to its market growth:

• Reduced Delirium: Studies suggest that dexmedetomidine may be associated with less delirium and neurocognitive dysfunction compared to other sedatives[2].
• Improved Analgesia: It decreases perioperative opioid consumption and improves postoperative analgesia, reducing adverse side effects like postoperative nausea and vomiting (PONV).

Future Outlook

The future outlook for the dexmedetomidine market is promising, driven by increasing awareness of its benefits, ongoing clinical research, and innovations in drug formulations. As the demand for efficient sedation and analgesia continues to rise, especially in critical care and surgical settings, the market is expected to expand significantly.

"Dexmedetomidine is associated with lower ICU costs, largely due to a shorter time to extubation and ICU stay"[2].

Key Takeaways

• The dexmedetomidine market is projected to grow significantly, reaching USD 3.1 billion by 2031 and potentially USD 4.6 billion by 2032.
• The market is driven by its increasing use in ICUs and surgical settings, preference over traditional sedatives, and innovations in drug formulations.
• Key challenges include side effects and the need for cautious use in patients with liver disease.
• The economic benefits of reduced ICU costs and improved clinical outcomes are significant drivers of market growth.

FAQs

What is the projected market size of dexmedetomidine by 2031?

The dexmedetomidine market is expected to reach USD 3.1 billion by 2031, growing at a CAGR of 6.7% from 2024 to 2031[3].

What are the primary applications of dexmedetomidine?

The primary applications include intensive care unit sedation, procedural sedation, and use in operating rooms and ambulatory care[2][3].

What are the key benefits of dexmedetomidine over traditional sedatives?

Dexmedetomidine offers improved hemodynamic stability, less respiratory depression, and reduced delirium and neurocognitive dysfunction compared to traditional sedatives[2].

How is dexmedetomidine metabolized and excreted?

Dexmedetomidine is metabolized by the liver and excreted primarily in the urine, with a terminal elimination half-life of approximately 2-4 hours[2].

What are the potential side effects of dexmedetomidine?

Common side effects include bradycardia and hypotension, particularly at higher doses. It should be used cautiously in patients with liver disease or hepatic impairment[2].

Sources

1. Market Research Intellect: Dexmedetomidine Hydrochloride For Injection Market Size And Forecast.
2. Wikipedia: Dexmedetomidine.
3. Market Research Intellect: Global Dexmedetomidine Market Size, Share, Trends, Scope And Forecast.
4. Business Research Insights: Dexmedetomidine Market Size, Share, Forecast, 2032.
5. ASRA Newsletter: Review of Dexmedetomidine (Precedex) for Acute Pain and Analgesia.