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:	448
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 seven 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	8,242,158*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes	9,616,049*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes	8,455,527*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	AP	RX	Yes	Yes	8,455,527*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	AP	RX	Yes	Yes	8,648,106*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-001	Dec 17, 1999	AP	RX	Yes	Yes

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	5,344,840

International Patents for PRECEDEX

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

Country	Patent Number	Title	Estimated Expiration
Austria	71941
Australia	1894188
Australia	600839
Bulgaria	60473
Canada	1337659	ISOMERES OPTIQUES D'UN DERIVE DE L'IMIDAZOLE (OPTICAL ISOMERS OF AN IMIDAZOLE DERIVATIVE)
China	1022323
China	1030576

Supplementary Protection Certificates for PRECEDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0300652	91010	Luxembourg
0300652	300117	Netherlands		300117, 20080708, EXPIRES: 20130707
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
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	7/2003	Austria		PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
1069893	C01069893/01	Switzerland		FORMER OWNER: ORION CORPORATION, FI

PRECEDEX (dexmedetomidine) market dynamics and financial trajectory: revenue drivers, pricing pressure, competition, and exclusivity-driven risk

Last updated: July 30, 2026

Executive summary

• PRECEDEX (dexmedetomidine HCl) is a niche but high-value critical-care and procedural sedative with a market concentrated in hospitals and ambulatory surgery centers.
• Financial trajectory is shaped by (1) conversion dynamics from older sedation practices, (2) hospital formulary access and contracting, (3) controlled-substance and safety-driven utilization, (4) generic and biosimilar-adjacent competition risk (primarily generic small molecules, not biologics), and (5) regulatory access via FDA labeling and controlled distribution.
• The product’s long-run economics are constrained by class substitution within sedatives (e.g., propofol, midazolam, ketamine) and by generic dexmedetomidine entry risks that compress net prices once barrier patents and regulatory exclusivities lapse.
• Market expansion depends more on clinical protocol adoption and payer/hospital purchasing behavior than on blockbuster-type demand growth.

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PRECEDEX market size and unit demand: how is dexmedetomidine used across ICUs and procedures?

Short answer: PRECEDEX demand is driven by hospital procedural throughput and ICU sedation protocols, with dosing intensity tied to monitored sedation pathways rather than chronic use.

Where PRECEDEX is typically adopted

• ICU sedation (including mechanically ventilated and non-intubated settings where clinicians prefer cooperative sedation).
• Postoperative and procedural sedation where titratability and patient interaction matter.
• Short-duration monitored anesthesia workflows in hospital and select outpatient environments.

Key demand drivers

1. Protocol preference for “cooperative sedation”
   • Dexmedetomidine’s ability to allow patient arousability supports protocols that aim to reduce delirium risk or facilitate neurologic assessments.
2. Safety and workflow fit
   • Clinicians select agents that balance hemodynamics, respiratory drive, and nursing titration workload.
3. Procurement and contracting
   • Net price is heavily influenced by GPO contracts, wholesaler buy programs, and group purchasing organization pricing.

Key demand constraints

• Substitution pressure from other sedatives (propofol, benzodiazepines, ketamine, and combination regimens).
• Hemodynamic adverse-effect management (bradycardia and hypotension can limit use in some patient populations, shifting clinicians to alternatives or dose adjustments).
• State and institutional controlled-substance and infusion monitoring controls that slow adoption.

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How do PRECEDEX pricing and reimbursement dynamics work in hospital buying?

Short answer: Net pricing is determined by hospital contracting, utilization thresholds, and formulary status. List price is only the starting point.

Net price mechanics that move financials

• GPO and IDN contracting: Hospitals often negotiate multi-tier pricing tied to annual spend and case volumes.
• Tender/bid dynamics: Competitive pressure from generic dexmedetomidine can trigger price resets.
• Tender bundling: PRECEDEX may be bundled with infusion devices, pharmacy services, or broad ICU portfolios that preserve gross-to-net stability until competing SKUs are included.
• Pharmacy and therapeutics committee decisions: Formulary status can shift demand even without major clinical changes.

What typically happens during generic entry

• Net price declines faster than list price once clinicians shift to lower-cost dexmedetomidine equivalents.
• Hospitals can preserve incumbent share briefly via “switch-back avoidance” costs, but long-term share trends track formulary replacement and pharmacy conversions.

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What competition does PRECEDEX face: generics, therapeutic alternatives, and substitution

Short answer: The competitive set includes both direct generic dexmedetomidine products and therapeutic substitution from other sedative classes.

Direct competition: generic dexmedetomidine

• Competition is primarily small-molecule generic drug products with the same active ingredient.
• Financial impact comes from:
  • formulary replacement
  • pharmacy interchange programs
  • tender-led price resets

Indirect competition: other ICU and procedural sedatives

• Propofol: common in ICU and procedural settings, often selected for depth-control and short recovery.
• Midazolam: widely used for anxiolysis and sedation, though delirium and respiratory-depression concerns can affect selection.
• Ketamine: used for specific clinical scenarios, often where analgesia and hemodynamics support use.
• Other sedative regimens: combination strategies and institutional protocol changes.

Why PRECEDEX can maintain share even with alternatives

• Clinical protocol lock-in
  • Once a hospital standardizes sedation workflows, changing agents is slow unless evidence, outcomes, or pricing compel a switch.
• Operational fit
  • Nursing familiarity with titration and monitoring can preserve use patterns.

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When do PRECEDEX revenues typically peak or re-rate: exclusivity, FDA status, and formulary timing

Short answer: Revenue step-down risk concentrates around exclusivity expiration and generic entry timing, plus contract renewal cycles after entry.

Exclusivity-driven revenue behavior

• Incumbent revenues tend to hold up until a new competitive threshold:
  1. FDA approval of generic or lower-cost equivalents.
  2. Labeling expansions or contract reallocations that alter prescribing behavior.
  3. Formulary committee decisions to remove branded product.

Contract cycle effects

• Even after regulatory approval, net price declines usually accelerate when:
  • tenders are re-bid
  • institutional pharmacy converts inventory
  • purchasing moves to the lowest-cost compliant SKU

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What patents protect PRECEDEX and how many are in-force across key jurisdictions?

Short answer: A comprehensive patent estate mapping requires Orange Book and patent litigation records, including formulation, method-of-use, and manufacturing claims. Without a full in-force dataset, a complete quantified count across jurisdictions cannot be produced.

Patent clusters that typically matter for PRECEDEX-style small-molecule injectables

• Active ingredient composition claims (rarely the dominant factor at late stages for established actives).
• Formulation or concentration-specific composition claims
• Method-of-use claims (ICU sedation, postoperative sedation, particular dosing regimens)
• Manufacturing and process claims (sterility, purification steps, stability)

Where generic entry risk concentrates

• Generic entrants challenge the strongest remaining barriers:
  • composition and formulation
  • use claims
  • process claims
• Settlement agreements often lock in:
  • temporary launch delays
  • design-around commitments
  • carve-outs to non-infringing indications or strengths

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What is the Orange Book status of PRECEDEX and what does it imply for generic entry risk?

Short answer: Orange Book status determines the legal exposure path for generic entry. A full status breakdown requires live Orange Book listing data and associated patents for PRECEDEX.

How to interpret Orange Book indicators for financial exposure

• Multiple listed patents usually mean staggered legal risk.
• The presence of method-of-use patents can extend exclusivity beyond composition.
• Expiration schedules guide probability-weighted launch timelines for Paragraph IV.

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Has PRECEDEX faced Paragraph IV challenges or been involved in patent litigation that changed market share?

Short answer: Patent litigation materially affects generic launch timing and therefore net price trajectory, but a complete litigation chronology requires verified case-by-case docket and settlement data tied to PRECEDEX.

Market impact channels of patent outcomes

• Early patent wins delay generic entry and protect incumbent net price.
• Settlements can create “authorized” delayed entry and reduce later price volatility.
• Final adjudications can open immediate switch risks in hospital formularies.

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What generic launch scenarios exist for PRECEDEX and what is the revenue impact path?

Short answer: The typical sequence is regulatory approval first, then formulary conversion, then sustained price compression.

Scenario framework investors use

1. Delayed entry scenario
   • Patents or injunctions delay launch.
   • Revenue declines mainly occur via contracting renegotiations rather than SKU substitution.
2. Staggered entry scenario
   • Multiple generics launch over time, each eroding net price incrementally.
3. Rapid replacement scenario
   • If a dominant low-cost product wins tender or pharmacy interchange, branded share drops quickly.

Financial exposure

• Short-term: gross-to-net deterioration from competitive contracting and wholesaler discounting.
• Medium-term: revenue decline from volume share loss after formulary replacement.
• Longer-term: brand persists only in higher-acuity or protocol-locked subsegments.

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How does PRECEDEX compare with competing sedation drugs on market traction and substitution risk?

Short answer: PRECEDEX’s differentiation is clinical workflow fit and titratability, but substitution risk remains high once lower-cost dexmedetomidine equivalents are available.

Competitive differentiation axes

• Clinical positioning
  • PRECEDEX competes on cooperative sedation and titration.
• Operational fit
  • Delivery system and infusion workflow influence uptake.
• Cost
  • Net price governs hospital purchasing once efficacy and safety are clinically acceptable for competing options.

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Regulatory and labeling dynamics: do new indications or FDA label changes move PRECEDEX sales?

Short answer: Label changes can drive incremental uptake, but sustained financial impact usually requires formulary action and clinician protocol adoption.

What matters for revenue uplift

• Breadth of supported clinical use
• Strengths and dosing ranges
• Hospital adoption barriers (protocol, nursing education, pharmacy compounding rules)
• Compatibility with sedation pathways
  • e.g., ICU sedation guidelines that cite dexmedetomidine

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Commercial trajectory: what metrics best explain PRECEDEX financial performance?

Short answer: Hospitals buy based on protocol adoption and contracted unit costs; therefore, metrics tied to dispensing and tender outcomes drive revenue more than market-wide incidence.

Metrics to track

• U.S. hospital demand index (ICU bed-days, procedure mix, sedation protocol adoption)
• Gross-to-net trend
  • proxy for contracting pressure and competitive SKU presence
• Channel inventory
  • fast inventory turns indicate share retention; slow turns can indicate stock shifting post-tender
• Unit share trends
  • branded vs generic dexmedetomidine share, stratified by hospital IDN type

Where margin pressure comes from

• Increased competitive price points reduce contracted pricing.
• Increased promotion or contracting concessions to preserve share compress gross margin.

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Key Takeaways

• PRECEDEX market dynamics are driven by hospital protocol adoption, contracting and formulary status, and substitution pressure from both generic dexmedetomidine and other sedation classes.
• Financial trajectory is most exposed around regulatory and patent-driven generic entry timing, followed by institutional switching during contract renewals and tenders.
• Durable brand value depends on maintaining formulary access and net pricing, not just clinical differentiation.

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FAQs

1. What drives PRECEDEX prescribing in ICUs more than other sedatives?
2. How do hospital GPO contracts typically change PRECEDEX net pricing after generic entry?
3. What are the main clinical reasons clinicians limit dexmedetomidine use (and how does that affect demand)?
4. How does formulary status influence PRECEDEX volume share versus therapeutic alternatives?
5. What revenue risk timing matters most for PRECEDEX: patent expiry, FDA approval, or contract conversion?

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References

No sources were provided or verified in the prompt, and no Orange Book, FDA, litigation, or financial reporting data was included.

DrugChatter Q&A for PRECEDEX

Generic name for precedex?