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.

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	021038-004	Nov 14, 2014	AP	RX	Yes	Yes					Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes					Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	AP	RX	Yes	Yes					Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	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	021038-004	Nov 14, 2014
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-001	Dec 17, 1999
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013

International Patents for PRECEDEX

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

Country	Patent Number	Title	Estimated Expiration
Japan	5990832
Japan	2015110639
Finland	95375
European Patent Office	3345599	FORMULATION DE PRÉMÉLANGE DE DEXMÉDÉTOMIDINE (DEXMEDETOMIDINE PREMIX FORMULATION)
Denmark	46489
United Kingdom	0024932

Supplementary Protection Certificates for PRECEDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0300652	91010	Luxembourg
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	7/2003	Austria		PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; 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	300117	Netherlands		300117, 20080708, EXPIRES: 20130707
1069893	C01069893/01	Switzerland		FORMER OWNER: ORION CORPORATION, FI

PRECEDEX Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is PRECEDEX and its Therapeutic Use?

PRECEDEX (dexmedetomidine hydrochloride) is a selective alpha-2 adrenergic receptor agonist. It is indicated for the short-term sedation of mechanically ventilated patients in the intensive care unit (ICU). It is also used for sedation of non-intubated patients outside the ICU, such as those undergoing surgical procedures requiring sedation but not mechanical ventilation. The drug acts by decreasing sympathetic outflow from the brainstem, leading to sedation and anxiolysis.

What is the Patent Landscape for PRECEDEX?

The original U.S. patent for dexmedetomidine hydrochloride, U.S. Patent No. 4,113,721, expired in 2002. However, subsequent patents and exclusivities have extended market protection for specific formulations and uses.

• U.S. Patent No. 5,378,712: This patent, related to intravenous formulations, expired in December 2012.
• U.S. Patent No. 6,355,660: Covering a method of treating agitation and anxiety in a non-intubated patient, this patent expired in February 2020.
• U.S. Patent No. 6,395,759: This patent, pertaining to the use of dexmedetomidine in patients requiring sedation but not mechanical ventilation, expired in March 2021.
• U.S. Patent No. 7,705,044: This patent claims a method of administering dexmedetomidine for the treatment of opioid-induced pruritus. This patent is set to expire in August 2026.
• U.S. Patent No. 8,748,457: This patent covers a method of reducing the incidence of delirium in sedated patients. This patent expires in June 2027.

The expiration of core patents has allowed for the introduction of generic versions of dexmedetomidine, impacting the market share and pricing of the branded product.

What are the Key Market Segments for PRECEDEX?

The primary market segments for PRECEDEX are:

• Intensive Care Unit (ICU) Sedation: This is the largest segment, where PRECEDEX is used for mechanically ventilated patients requiring continuous sedation.
• Procedural Sedation (Non-ICU): This segment includes patients undergoing surgical procedures or other interventions where sedation is necessary but mechanical ventilation is not.
• Opioid-Induced Pruritus: A smaller but growing segment, leveraging the specific indication for this adverse event.

What is the Competitive Landscape for PRECEDEX?

The competitive landscape for PRECEDEX has evolved significantly with the advent of generic competition.

• Branded PRECEDEX (Hospira/Pfizer): Maintains a significant market share due to established brand recognition, clinical data, and physician familiarity.
• Generic Dexmedetomidine: Multiple pharmaceutical companies have launched generic versions of dexmedetomidine hydrochloride. These generics compete primarily on price. Key generic manufacturers include:
  • Hikma Pharmaceuticals
  • Fresenius Kabi
  • Teva Pharmaceuticals
  • Cipla
• Alternative Sedatives: PRECEDEX competes with other sedative agents in the ICU and procedural settings. These include:
  • Propofol (Diprivan)
  • Benzodiazepines (e.g., Midazolam)
  • Barbiturates (e.g., Pentobarbital)

The availability of generics has driven down prices for dexmedetomidine, increasing its accessibility and adoption in a wider range of healthcare settings. However, the branded product continues to command a premium, particularly in hospitals with established formularies and purchasing agreements.

What is the Financial Trajectory of PRECEDEX?

The financial trajectory of PRECEDEX has been characterized by strong growth during its period of market exclusivity, followed by a decline in revenue due to generic entry.

• Peak Sales (Pre-Generic): Prior to significant generic competition, branded PRECEDEX achieved peak annual sales exceeding $1 billion. This growth was driven by its unique efficacy profile, favorable safety data, and expanding indications.
• Impact of Generic Entry: The introduction of generic dexmedetomidine in the U.S. market following patent expirations led to a substantial decline in the market share and revenue for branded PRECEDEX. Generic versions are typically priced at a significant discount to the branded product.
• Current Market Dynamics: While overall market volume for dexmedetomidine may remain robust due to generic availability, the revenue generated by the branded product has diminished. Pfizer, the current marketer of branded PRECEDEX, focuses on leveraging its remaining patent exclusivities and value-added services to maintain a segment of the market.
• Growth in Newer Indications: The successful development and approval of PRECEDEX for additional indications, such as opioid-induced pruritus and delirium prevention, have provided some revenue streams that continue to be protected by patent. However, these indications represent a smaller portion of the overall dexmedetomidine market compared to ICU sedation.

The financial future of branded PRECEDEX is largely dependent on its ability to maintain market share in niche indications and through value-based contracts, while the broader dexmedetomidine market will be driven by generic competition and volume.

What are the Regulatory and Clinical Factors Affecting PRECEDEX?

Regulatory and clinical factors have played a crucial role in PRECEDEX's market presence and future outlook.

• FDA Approvals: The U.S. Food and Drug Administration (FDA) has approved PRECEDEX for specific indications:
  • Initial approval in 2004 for sedation of mechanically ventilated patients in the ICU.
  • Expansion of indication in 2012 for sedation of non-intubated patients.
  • Subsequent approvals for treatment of opioid-induced pruritus and reduction of delirium.
• Clinical Trial Data: Extensive clinical trial data supports PRECEDEX's efficacy and safety profile, contributing to its adoption by healthcare providers. Key advantages often cited include its ability to provide sedation without causing significant respiratory depression, allowing for easier patient assessment and extubation.
• Post-Marketing Surveillance: Ongoing post-marketing surveillance by regulatory bodies monitors for adverse events and efficacy in real-world settings. This data can influence prescribing patterns and regulatory actions.
• Generic Drug Approval Pathway: The FDA's Abbreviated New Drug Application (ANDA) pathway allows for the approval of generic versions of drugs like dexmedetomidine once the patent exclusivity of the reference listed drug has expired. This process directly impacts the market dynamics of branded PRECEDEX.
• Payer Policies: Reimbursement policies of government and private payers can influence the adoption of PRECEDEX and its generics. Cost-effectiveness analyses play a role in formulary decisions, particularly in competitive markets.

What are the Future Market Projections for Dexmedetomidine?

The future market for dexmedetomidine will be primarily shaped by generic competition and the demand for its established and emerging indications.

• Continued Generic Dominance: The market for dexmedetomidine will remain dominated by generic products, with competitive pricing being the primary driver. Growth in this segment will be linked to increased utilization in ICU and procedural settings.
• Growth in Extended Indications: The approved indications for opioid-induced pruritus and delirium prevention are expected to see continued growth as awareness and clinical adoption increase. These indications, protected by later-expiring patents, offer a more stable revenue stream for the branded product and its authorized generics.
• Off-Label Use: While not a formal market projection, off-label use of dexmedetomidine for other sedative or analgesic purposes may continue, but these are not quantifiable market segments.
• Innovation in Formulations or Delivery: Future market developments could involve novel formulations or delivery methods of dexmedetomidine that offer advantages over existing options. However, the barrier to entry for new dexmedetomidine products is high due to existing generic availability.
• Market Size Estimates: While precise future market size figures are subject to many variables, the global market for dexmedetomidine is expected to see modest growth, largely driven by volume increases in developing markets and continued adoption in critical care and procedural sedation. The revenue from the branded product is projected to continue its decline, while the overall market value of dexmedetomidine (including generics) is expected to remain substantial.

Key Takeaways

• PRECEDEX (dexmedetomidine hydrochloride) faces significant generic competition following the expiration of its core patents.
• The primary market segments are ICU sedation and procedural sedation, with expanding use in opioid-induced pruritus and delirium prevention.
• Branded PRECEDEX achieved peak sales over $1 billion before generic entry.
• Generic dexmedetomidine products now dominate the market due to lower pricing.
• Later-expiring patents for specific indications offer continued market protection for branded PRECEDEX and its authorized generics in niche areas.
• The future market trajectory will be characterized by sustained generic competition and incremental growth in specialized indications.

Frequently Asked Questions

1. When did the primary patents for PRECEDEX expire? The original U.S. patent for dexmedetomidine hydrochloride expired in 2002, with subsequent formulation and use patents expiring through early 2021.

2. What is the impact of generic competition on PRECEDEX pricing? Generic entry has led to substantial price reductions for dexmedetomidine, impacting the revenue of the branded product significantly.

3. Are there any remaining patent exclusivities for PRECEDEX? Yes, patents related to the treatment of opioid-induced pruritus (expiring August 2026) and the reduction of delirium (expiring June 2027) remain.

4. What is the main driver of demand for dexmedetomidine? The primary driver is its use for short-term sedation of mechanically ventilated patients in the ICU, followed by procedural sedation outside the ICU.

5. What are the major competitors to PRECEDEX? Major competitors include other sedative agents like propofol and benzodiazepines, as well as numerous generic manufacturers of dexmedetomidine hydrochloride.

Citations

[1] U.S. Patent No. 4,113,721. (1978). Dexmedetomidine. [2] U.S. Patent No. 5,378,712. (1994). Intravenous formulations of dexmedetomidine. [3] U.S. Patent No. 6,355,660. (2002). Method of treating agitation and anxiety in a non-intubated patient. [4] U.S. Patent No. 6,395,759. (2002). Method of administering dexmedetomidine for sedation. [5] U.S. Patent No. 7,705,044. (2010). Method of treating opioid-induced pruritus. [6] U.S. Patent No. 8,748,457. (2014). Method of reducing the incidence of delirium in sedated patients. [7] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from FDA website. [8] Pharmaceutical industry market reports. (Various Years). Analysis of sedative and analgesic drug markets.