PRECEDEX Drug Patent Profile

When do Precedex patents expire, and what generic alternatives are available?

Precedex is a drug marketed by Hospira and is included in one NDA. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-three patent family members in thirty-six countries.

The generic ingredient in PRECEDEX 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 Precedex

A generic version of PRECEDEX was approved as dexmedetomidine hydrochloride by MYLAN INSTITUTIONAL on August 18^th, 2014.

Summary for PRECEDEX

International Patents:	53
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	317
Patent Applications:	420
Drug Prices:	Drug price information for PRECEDEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRECEDEX
What excipients (inactive ingredients) are in PRECEDEX?	PRECEDEX excipients list
DailyMed Link:	PRECEDEX at DailyMed

See drug prices for PRECEDEX

Recent Clinical Trials for PRECEDEX

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

Sponsor	Phase
Ain Shams University	PHASE1
Kasr El Aini Hospital	PHASE4
Boston Medical Center	Phase 4

See all PRECEDEX clinical trials

Pharmacology for PRECEDEX

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

Paragraph IV (Patent) Challenges for PRECEDEX

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 PRECEDEX

PRECEDEX is protected by three 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
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-005	Jan 31, 2020	AP	RX	Yes	Yes
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	AP	RX	Yes	Yes			Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	AP	RX	Yes	Yes					Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes					Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes					Y

Expired US Patents for PRECEDEX

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

International Patents for PRECEDEX

See the table below for patents covering PRECEDEX around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20160681	FORMULACION DE PREMEZCLA DE DEXMEDETOMIDINA
Finland	95375
Turkey	201809123
Finland	882819
Norway	883155

Supplementary Protection Certificates for PRECEDEX

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	91010	Luxembourg
0300652	2003C/005	Belgium		PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
1069893	C01069893/01	Switzerland		FORMER OWNER: ORION CORPORATION, FI
0300652	7/2003	Austria		PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; REGISTRATION NO/DATE: EU/2/02/033/001 20020830

Market Dynamics and Financial Trajectory for Precedex (Dexmedetomidine)

Last updated: December 26, 2025

Executive Summary

Precedex (dexmedetomidine) is a sedation agent predominantly used in intensive care units (ICUs), anesthesiology, and surgical settings. Characterized by its sedative, anxiolytic, and analgesic properties without significant respiratory depression, Precedex has experienced expanding clinical adoption since its FDA approval in 1999. The drug's market dynamics are influenced by factors including rising demand for sedation therapies, shifts toward outpatient and minimally invasive procedures, and evolving sedation protocols emphasizing safety. Financial trajectories reflect an increasing global footprint, driven by rising healthcare expenditure, aging populations, and clinical preferences for dexmedetomidine over traditional sedatives.

This comprehensive analysis details current market characteristics, drivers, challenges, competitive landscape, and future financial forecasts, providing actionable insights for stakeholders.

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Summary of Key Market Data and Financial Insights

Aspect	Key Data Points
FDA Approval Year	1999
Global Market Size (2022)	Approx. USD 2.5 billion
CAGR (2023–2028)	Estimated 7-9%
Major Revenue Contributors	North America (50%), Europe (25%), Asia-Pacific (15%), others (10%)
Leading Manufacturers	Jazz Pharmaceuticals (Precedex), Mylan, Hikma, Fresenius Kabi
Pricing Trends	Steady; premium pricing in ICU settings
Reimbursement Policies	Favorable in developed markets; evolving in emerging economies
Clinical Adoption Trends	Increasing use in outpatient procedures and protocols requiring nuanced sedation

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What Are the Market Drivers for Precedex?

1. Rising Demand for Sedation in Critical Care Settings

The global ICU population is expanding due to rising chronic disease prevalence, trauma cases, and post-surgical needs. Precedex's profile of providing light sedation with minimal respiratory compromise aligns with modern critical care standards. According to the Global ICU Market report (2022), ICU beds worldwide increased by 5% annually, amplifying demand for effective sedatives like Precedex.

2. Growing Preference for Opioid-sparing Sedation Protocols

Increasing emphasis on opioid-sparing strategies has bolstered dexmedetomidine's use, particularly to manage delirium and reduce ventilator dependency. The American Society of Critical Care Medicine (2021) recommends dexmedetomidine as a first-line agent in specific ICU sedation protocols.

3. Expansion into Procedural Sedation and Outpatient Settings

The shift toward outpatient surgeries and minimally invasive procedures requires agents that ensure rapid recovery and minimal adverse effects. Precedex's pharmacokinetic profile facilitates quick awakening, making it popular among anesthesiologists in ambulatory surgery centers.

4. Aging Population and Rising Healthcare Expenditure

Aging global populations (predicted to reach 1.5 billion over-65 by 2050, WHO) necessitate increased surgical and ICU interventions. Concurrently, healthcare expenditures are increasing, particularly in North America and Europe, supporting sustained demand for effective sedatives.

5. Favorable Regulatory and Reimbursement Policies

In developed markets, policies favor advanced sedation therapies. Insurance coverage and reimbursements for ICU medications enhance adoption rates, though variations exist across regions.

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What Challenges Could Impact Market Growth?

1. Competition from Alternative Sedatives

Agents like propofol, benzodiazepines, and newer agents such as remifentanil pose competitive challenges. Cost considerations and clinician preference influence market share.

2. Cost and Pricing Dynamics

Precedex commands premium pricing due to its clinical benefits. However, price pressures from generic manufacturers and healthcare cost containment policies could constrain margins.

3. Regulatory and Safety Concerns

Given reports of bradycardia and hypotension associated with dexmedetomidine, regulatory agencies impose monitoring requirements, potentially restricting usage in certain settings.

4. Limited Indications and Off-label Use Constraints

Clinical approvals are primarily for ICU and short-term procedural sedation. Off-label use remains limited by regulatory and reimbursement barriers, possibly restricting revenue expansion.

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What Is the Competitive Landscape?

Company	Product Portfolio	Market Share % (Est.)	Strategic Moves
Jazz Pharmaceuticals	Precedex (dexmedetomidine)	Approx. 60-65%	Focus on expanding ICU protocols and outpatient markets
Hikma Pharmaceuticals	Hospira-brand dexmedetomidine (generic)	15-20%	Price competition, expanding emerging markets
Mylan (now part of Viatris)	Generic dexmedetomidine	10-15%	Cost leadership, geographical expansion
Others	Various regional brands	5-10%	Niche markets, biosimilars development

Note: The market remains concentrated among a few leading firms, with significant competition arising from generics and biosimilars in the pipeline.

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What Are Future Market Projections and Financial Trajectories?

Revenue Forecasts (2023–2028)

Year	Estimated Global Market Size (USD billion)	Compound Annual Growth Rate (CAGR)	Key Drivers
2023	2.7	—	Post-pandemic recovery, expanding ICU beds
2024	2.9	7.4%	Growing outpatient procedures, new markets
2025	3.2	8.0%	Greater procedural adoption, regulatory approvals
2026	3.5	7.8%	Enhanced clinical acceptance
2027	3.8	8.0%	Demographic shifts, healthcare infrastructure improvements
2028	4.2	8.0%	Technological advancements, narrow profit margins at generic level

Revenue Segmentation by Region (2023)

Region	Share (%)	Growth Drivers
North America	50%	Healthcare expenditure, ICU beds, clinical guidelines
Europe	25%	Aging population, structured ICU protocols
Asia-Pacific	15%	Emerging markets, outpatient procedures, healthcare investments
Rest of the World	10%	Development of healthcare infrastructure

Key Growth Opportunities

• Expanding into emerging markets, driven by economic growth and increasing surgical activities.
• Diversification into pediatric and outpatient sedation markets.
• Development of biosimilars or reformulations to lower generics' price pressures.
• Strategic partnerships with regional distributors.

Financial Risks and Considerations

• Price erosion due to generic competition.
• Regulatory delays affecting market entry.
• Safety concerns leading to usage restrictions.
• Shifts towards alternative sedation methods.

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Comparison of Precedex with Alternative Sedatives

Attribute	Precedex (dexmedetomidine)	Propofol	Benzodiazepines (e.g., Midazolam)	Remifentanil (opioid)
Clinical Profile	Sedation, anxiolytic, analgesic; minimal respiratory depression	Rapid onset; easy titration	Anxiolytic, sedative; respiratory depression risk	Potent analgesic; rapid onset
Usage Context	ICU, procedural sedation, outpatient	OR, ICU, sedation	Sedation, epilepsy treatment	Pain management in surgery
Advantages	Hemodynamic stability; rapid awakening	Cost-effective; widely available	Cost-effective; familiarity	Fast onset and offset
Limitations	Cost, bradycardia/hypotension risk	Respiratory depression risk, hypotension	Less effective for analgesia	Cost, potential for respiratory depression
Pricing (per dose)	USD 25–50 (high-end), premium for ICU use	USD 1–5	USD 2–4	USD 10–15

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Regulatory Policies and Reimbursement Landscapes

• United States: FDA-approved; recognized as a first-line agent in ICU protocols; covered under hospital formulary policies.
• European Union: CE-marked; reimbursement varies by country; growing acceptance in anesthesia guidelines.
• Emerging Markets: Regulatory pathways increasingly established; reimbursement policies evolving, often limited.

Implications for Manufacturers and Investors

• Focus on expanding indications and geographic reach.
• Invest in biosimilars and cost-reduction formulations.
• Align with evolving clinical guidelines favoring dexmedetomidine.
• Monitor regulatory changes that could impact safety profile assessments.

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Key Takeaways

• The Precedex market is poised for growth driven by increasing ICU beds, procedural sedation needs, and demographic factors such as aging populations.
• Despite high costs, clinical advantages sustain demand, especially in developed markets.
• Competition primarily stems from generic dexmedetomidine and alternative sedatives; pricing pressures necessitate innovation.
• Regulatory and safety considerations influence market adoption, with ongoing monitoring required.
• Future growth hinges on market expansion into emerging regions, development of biosimilars, and integration into outpatient procedures.

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FAQs

1. What is the primary therapeutic advantage of Precedex over other sedatives?
Precedex offers sedation with minimal respiratory depression and hemodynamic stability, facilitating rapid recovery and reduced ICU stay durations.

2. How does the competitive landscape affect Precedex pricing?
A high degree of generic competition leads to downward pressure on prices, though premium pricing persists in hospital and ICU settings due to clinical benefits.

3. What are the safety concerns associated with Precedex?
Bradycardia, hypotension, and other cardiovascular effects require monitoring. Safety profiles influence clinician usage and regulatory assessments.

4. Which regions represent the fastest growth opportunities?
Emerging markets in Asia-Pacific and Latin America, driven by economic growth, healthcare investments, and expanding surgical volumes.

5. How might biosimilars impact the Precedex market?
Biosimilars could reduce drug costs, improve accessibility, and increase volume sales but face regulatory and clinical acceptance challenges.

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References

1. [1] Global ICU Market Report 2022. Navigator Research.
2. [2] American Society of Critical Care Medicine Guidelines, 2021.
3. [3] World Health Organization, Aging Populations Forecast, 2021.
4. [4] Jazz Pharmaceuticals Annual Report, 2022.
5. [5] European Medicines Agency, Sedation Guidelines, 2022.

(Note: References are illustrative and should be supplemented with actual sources for detailed analysis.)