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-one patent family members in thirty-five countries.

The generic ingredient in PRECEDEX 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 Precedex

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

Summary for PRECEDEX

International Patents:	51
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	312
Patent Applications:	222
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
Boston Medical Center	Phase 4
Ain Shams University	Phase 4
Kaohsiung Medical University Chung-Ho Memorial Hospital	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		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	021038-001	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
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
Mexico	2013003629	DEXMEDETOMIDINE PREMIX FORMULATION.
Australia	2013201069
Taiwan	201630603
Denmark	386288
Hungary	229162	Dexmedetomidin nyugtatószerként történõ alkalmazása intenzív osztályon (Use of dexmedetomidine as sedative in intensive care)

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	2003C/005	Belgium		PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
0300652	91010	Luxembourg
1069893	C01069893/01	Switzerland		FORMER OWNER: ORION CORPORATION, FI
0300652	SPC/GB03/005	United Kingdom		PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830

PRECEDEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Precedex (Dexmedetomidine)

Introduction to Precedex

Precedex, known generically as dexmedetomidine, is an alpha-2 adrenergic agonist used primarily for sedation in intensive care units (ICUs) and procedural sedation in non-intubated patients. Its unique properties, including sedation with minimal respiratory depression, make it a valuable asset in the healthcare industry.

Market Size and Growth

The global dexmedetomidine market is projected to experience significant growth. From 2022 to 2033, the market size is expected to increase from USD 1,178.20 million to USD 5,076.29 million, with a Compound Annual Growth Rate (CAGR) of 14.20%[1].

Key Drivers of Market Growth

Increasing Demand in Healthcare

The growing need for sedative agents with hemodynamic stability and minimal respiratory depression is a major driver. Dexmedetomidine's ability to facilitate early weaning from mechanical ventilation and reduce the incidence of agitated delirium in ICU patients has boosted its demand[1].

Aging Population and Health Trends

The increasing global population of older adults, along with rising rates of hypertension, depression, and other diseases, has also contributed to the market growth. Dexmedetomidine's use in aesthetic procedures and its benefits in reducing postoperative delirium and cognitive dysfunction further enhance its market appeal[1][2].

Regulatory Approvals and Clinical Efficacy

The drug has undergone rigorous clinical trials and has received regulatory approvals. For instance, Health Canada approved Precedex after thorough evaluations of its efficacy and safety, which has bolstered its market position[3].

Market Segmentation

By Product Type

The dexmedetomidine market is segmented into intensive care unit (ICU) sedation, procedural sedation, and other applications. The ICU sedation segment dominates the market due to dexmedetomidine's effectiveness in maintaining sedation while preserving respiratory function and reducing delirium in ICU patients[1].

By Region

North America is expected to hold the highest market share, driven by healthcare reform initiatives, increasing healthcare spending, and a growing population. Other regions, including Europe, Asia-Pacific, Middle East & Africa, and South America, also contribute significantly to the global market[1].

Financial Performance and Trends

Revenue Growth

The substantial growth in the dexmedetomidine market is reflected in its increasing revenue. The market's expansion from USD 1,178.20 million in 2022 to a projected USD 5,076.29 million by 2033 indicates a robust financial trajectory[1].

Competitive Landscape

The market is highly competitive, with key players employing strategies such as product launches, partnerships, acquisitions, and agreements to enhance their market positions. Companies are focusing on expanding their global operations and forming long-term partnerships to maintain market share[1].

Challenges and Limitations

Economic Impact of the COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on the healthcare industry, leading to supply chain disruptions and decreased demand for healthcare services. This has resulted in a slower growth rate for the dexmedetomidine market during the pandemic period[1].

Adverse Effects and Safety Concerns

Higher doses of dexmedetomidine can lead to hypotension and bradycardia, which are manageable but can impact market growth. Additionally, withdrawal symptoms can occur if the drug is administered for more than 24 hours and then stopped abruptly[3][5].

Clinical and Safety Profile

Pharmacodynamics and Pharmacokinetics

Dexmedetomidine's mechanism of action involves the activation of alpha-2 adrenoceptors, leading to sedation and sympatholysis. It reduces blood pressure and heart rate without significant respiratory depression. Clinical studies have shown its efficacy in maintaining sedation scores and reducing the need for rescue medications[3][5].

Adverse Reactions

Common adverse reactions include hypotension, bradycardia, and dry mouth. Co-administration with other anesthetics, sedatives, and opioids can enhance these effects, necessitating dosage adjustments[5].

Market Utilization and Distribution

Hospital and Pharmacy Settings

Dexmedetomidine is predominantly distributed to non-retail pharmacies, primarily non-federal hospitals. The drug utilization data indicates a significant increase in the number of patients billed for dexmedetomidine, with the adult population accounting for the majority of users[4].

Future Outlook

The future of the dexmedetomidine market looks promising, driven by its clinical efficacy, growing demand, and expanding applications. However, the market must navigate challenges such as the economic impact of global health crises and the management of potential adverse effects.

Key Takeaways

• Market Growth: The global dexmedetomidine market is expected to grow significantly, with a CAGR of 14.20% from 2022 to 2033.
• Key Drivers: Increasing demand in healthcare, an aging population, and regulatory approvals are major drivers.
• Market Segmentation: ICU sedation and North America dominate the market segments.
• Financial Performance: Revenue is projected to increase substantially, driven by market expansion and competitive strategies.
• Challenges: Economic impacts of the COVID-19 pandemic and adverse effects are key challenges.
• Clinical Profile: Dexmedetomidine offers unique sedative properties with minimal respiratory depression, but requires careful management of potential adverse reactions.

FAQs

Q: What is the primary use of Precedex (dexmedetomidine) in healthcare?

A: Precedex is primarily used for sedation in intensive care units (ICUs) and procedural sedation in non-intubated patients.

Q: How is the global dexmedetomidine market expected to grow?

A: The market is expected to grow from USD 1,178.20 million in 2022 to USD 5,076.29 million by 2033, with a CAGR of 14.20%.

Q: What are the common adverse reactions associated with Precedex?

A: Common adverse reactions include hypotension, bradycardia, and dry mouth.

Q: How does the COVID-19 pandemic impact the dexmedetomidine market?

A: The pandemic has led to supply chain disruptions and decreased demand for healthcare services, resulting in a slower growth rate.

Q: What is the significance of dexmedetomidine in reducing postoperative delirium?

A: Dexmedetomidine has been shown to significantly reduce the incidence of postoperative delirium and cognitive dysfunction, particularly in elderly patients undergoing major surgery[2].

Sources

1. Market Statsville Group: Dexmedetomidine Market 2022.
2. Frontiers in Neuroscience: The Effect and Optimal Dosage of Dexmedetomidine Plus Sufentanil.
3. Health Canada: Summary Basis of Decision for Precedex.
4. FDA: Precedex (dexmedetomidine) Safety and Drug Utilization Review.
5. Acute and Critical Care: Precedex - ACC.