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, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Ph Health, 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-seven 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 MYLAN INSTITUTIONAL on August 18^th, 2014.

Summary for DEXMEDETOMIDINE HYDROCHLORIDE

International Patents:	5
US Patents:	2
Applicants:	25
NDAs:	30
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,701
Patent Applications:	467
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEXMEDETOMIDINE HYDROCHLORIDE
DailyMed Link:	DEXMEDETOMIDINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE

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

Sponsor	Phase
Istinye University	NA
Tam Anh Research Institute	NA
Ataturk University	NA

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	212857-002	Nov 23, 2020	AP	RX	No	No
Mylan Labs Ltd	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	212571-001	Aug 27, 2020	AP	RX	No	No
Hq Spclt Pharma	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	SOLUTION;INTRAVENOUS	206628-003	Jun 22, 2018		RX	Yes	No	9,717,796		Y
Wilshire Pharms Inc	DEXMEDETOMIDINE HYDROCHLORIDE	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	212791-001	Dec 4, 2019	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

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

Market Dynamics and Financial Trajectory for Dexmedetomidine Hydrochloride

Last updated: July 27, 2025

Introduction

Dexmedetomidine hydrochloride, a selective alpha-2 adrenergic receptor agonist, has garnered significant attention within the pharmaceutical landscape for its sedative, anxiolytic, and analgesic properties. Its primary application spans critical care, anesthesia, and procedural sedation. As healthcare systems evolve and demands for efficacious sedation agents intensify, understanding the market dynamics and financial trajectories surrounding dexmedetomidine hydrochloride is pivotal for industry stakeholders.

Current Market landscape

The global dexmedetomidine hydrochloride market has experienced robust growth, driven primarily by increasing surgical procedures, expanding intensive care units (ICUs), and heightened focus on patient safety. The advent of biosimilars and patent expirations further influences market flexibility and pricing strategies. As per Recent reports, the global market size was valued at approximately USD 700 million in 2022, with projections indicating Compound Annual Growth Rates (CAGR) of around 8-10% through 2030 [1].

Key market segments

• Application in ICUs: Dexmedetomidine's popularity in ICU sedation is linked to its ability to facilitate conscious sedation and reduce ventilator-dependent durations.
• Anesthesia and procedural sedation: Its predictable sedation profile makes it a preferred agent for outpatient surgeries.
• Geographical Distribution: North America dominates owing to high procedural volumes and advanced healthcare infrastructure, followed by Europe and Asia-Pacific, which is witnessing rapid growth driven by emerging markets and expanding healthcare access.

Market Drivers

• Growing prevalence of intensive care units: The rising incidence of respiratory and cardiac conditions necessitates effective sedation agents.
• Shift towards preference for conscious sedation: Dexmedetomidine offers sedation without significant respiratory depression, making it desirable over traditional agents like benzodiazepines.
• Expanding surgical procedures globally: Increase in minimally invasive and outpatient procedures increases demand for targeted sedatives.
• Product approvals and new indications: Regulatory approvals expanding dexmedetomidine's label, including pediatric use, bolster market size.

Market Challenges and Restraints

• Pricing and reimbursement issues: Cost considerations and limited reimbursement in certain geographies can hinder adoption.
• Side effects and safety concerns: Potential for hypotension and bradycardia necessitate cautious use, impacting clinician preference.
• Availability of alternatives: Conventional sedatives remain competitive, constraining market expansion.
• Patent expiration and biosimilar entry: Although patent expiry can enhance accessibility, it may also lead to price competition, impacting revenue streams for innovator companies.

Competitive Landscape

Leading pharmaceutical firms such as Hospira (a Pfizer subsidiary), Fresenius Kabi, and Lee’s Pharmaceutical Holdings dominate the market. These companies focus on product differentiation, aggressive marketing, and strategic partnerships to secure market share.

Emerging players are also investing in formulations with improved safety profiles or novel delivery systems, fostering innovation-driven growth.

Financial Trajectory and Revenue Outlook

Forecasts suggest that the dexmedetomidine hydrochloride market will sustain a CAGR of approximately 8-10% from 2023 to 2030. This growth trajectory is supported by steady expansion in ICU and procedural sedation segments and increasing adoption in emerging markets.

Profitability analyses indicate that established players benefit from economies of scale, while new entrants face high regulatory and development costs but can leverage biosimilar pathways to capture markets more affordably [2].

Pricing strategies will influence revenue streams; premiums are maintained in developed regions due to brand recognition and clinical efficacy, whereas price sensitivity in emerging markets could incentivize competitive pricing and volume-based growth.

Regulatory and Innovation Factors

Regulatory agencies such as the FDA and EMA have approved dexmedetomidine for adult ICU sedation, with ongoing studies expanding its scope, including pediatric applications. This broadening of approved indications heightens market potential.

Innovative developments, like controlled-release formulations and combination therapies, can improve patient outcomes and offer competitive advantages, thereby influencing financial prospects.

Future Outlook

The continued integration of dexmedetomidine into sedation protocols and ongoing research into new indications (e.g., neuroprotection, analgesia adjuncts) promise sustained market growth. Strategic collaborations and licensing agreements are expected to facilitate access to emerging markets and diversify revenue streams.

However, market players must address safety concerns and develop cost-effective formulations to maintain competitive positioning. The adoption of biosimilars post-patent expiry will likely induce pricing pressures but can also expand access and volume sales.

Key Market Trends

• Increased adoption in non-intensive settings, such as emergency departments.
• Rising demand for personalized sedation protocols utilizing dexmedetomidine.
• Diversification into new formulations and fixed-dose combinations.
• Greater penetration in Asian and Latin American markets due to growing healthcare investments.

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Key Takeaways

• The dexmedetomidine hydrochloride market is poised for sustained growth driven by increasing procedural volumes, ICU admissions, and broader regulatory approvals.
• Competitive dynamics favor established firms, though biosimilar entries and innovation present opportunities for new entrants.
• Pricing strategies and safety profile improvements are critical in expanding market penetration, especially in cost-sensitive regions.
• Emerging indications and delivery innovations will enhance revenue streams and market valuation.
• Strategic collaborations and regulatory navigation are essential for maximizing financial returns in both mature and emerging markets.

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FAQs

1. What factors contribute to the growth of the dexmedetomidine hydrochloride market?
The primary factors include rising ICU admissions, increased procedural and surgical interventions, preference for conscious sedation, regulatory approvals expanding its indications, and technological innovations in formulation and delivery.

2. How does patent expiry impact the market?
Patent expiry enables biosimilar development, leading to increased competition and lower prices, which can reduce revenue for original manufacturers but also expand market access.

3. What safety concerns influence market adoption?
Potential for hypotension, bradycardia, and side effects necessitate caution, impacting clinician preference and adoption rates in certain settings.

4. Which geographical markets are predicted to see the highest growth?
Emerging markets in Asia-Pacific and Latin America are expected to experience significant growth due to increasing healthcare investments and expanding access.

5. What innovations are expected to shape the future of dexmedetomidine?
Development of controlled-release formulations, combination therapies, and expanded approved indications are key innovations anticipated to influence future market dynamics.

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References

[1] MarketWatch, "Global Dexmedetomidine Hydrochloride Market Size, Share & Trends Analysis," 2022.
[2] Grand View Research, "Dexmedetomidine Market Size, Share & Trends," 2023.