Dexmedetomidine hydrochloride - Generic Drug Details

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, 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, Hospira, Hq Spclt Pharma, and Somerset, and is included in thirty-two NDAs. There are twenty-two 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 thirty-two patent family members in thirty-eight countries.

There are nine drug master file entries for dexmedetomidine hydrochloride. Thirty suppliers are listed for this compound.

Summary for dexmedetomidine hydrochloride

International Patents:	132
US Patents:	22
Tradenames:	3
Applicants:	28
NDAs:	32
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1,344
Patent Applications:	373
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	212571-001	Aug 27, 2020	AP	RX	No	No
Bioxcel	IGALMI	dexmedetomidine hydrochloride	FILM;BUCCAL, SUBLINGUAL	215390-002	Apr 5, 2022		RX	Yes	Yes	11,497,711		Y
Fresenius Kabi Usa	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	208129-003	Nov 29, 2018	AP	RX	No	No
Hengrui Pharma	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	209065-001	Sep 19, 2017	AP	RX	No	No
Endo Operations	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	208266-001	Sep 15, 2020	AP	RX	No	No

Expired US Patents for dexmedetomidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-001	Dec 17, 1999	4,910,214*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	6,716,867*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	6,716,867*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	6,716,867*PED
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	4,910,214*PED

International Patents for dexmedetomidine hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	114983980
Japan	6929479
South Korea	20140096238	DEXMEDETOMIDINE PREMIX FORMULATION
Israel	224867
Australia	2020316013	Non-sedating dexmedetomidine treatment regimens

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

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.