CLINICAL TRIALS PROFILE FOR DIPRIVAN

All Clinical Trials for DIPRIVAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00336882 ↗	Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients	Terminated	Ministry of Health, France	Phase 3	2006-06-01	Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.
NCT00336882 ↗	Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients	Terminated	Rennes University Hospital	Phase 3	2006-06-01	Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.
NCT00390871 ↗	Acute Neurological ICU Sedation Trial (ANIST)	Completed	Daniel Hanley	Phase 2	2005-05-01	Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important. Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
NCT00390871 ↗	Acute Neurological ICU Sedation Trial (ANIST)	Completed	Johns Hopkins University	Phase 2	2005-05-01	Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important. Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
NCT00395681 ↗	Population PK/PD of Propofol in the Morbidly Obese Patient	Completed	St. Antonius Hospital	Phase 4	2007-09-01	Rationale: The extreme increase of obesity in the last years had led to this study. There is no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and dynamics in the morbidly obese patient. Reason for this is that it is not clear in what extend the pharmacokinetics and dynamics are affected in the morbidly obese patient. Objective: The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will take into account patient and procedure bound covariates. The results will be used to develop individualised dosing schemes of Propofol when used for induction and maintenance of anaesthesia in morbidly obese patients. Study design: A randomised, therapeutic and non-invasive study. Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old. Intervention (if applicable): Patients will be randomised into two groups, one group will be given 200 milligrams of Propofol and the other group will be given 350 milligrams of Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is asked to count in order to measure time to induction of anaesthesia. During and following anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other standard measures (heart frequency and blood pressure). Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment. Secondary endpoints: pharmacodynamic parameters; time to induction of anaesthesia (stop counting, eyelash reflex, quality of anaesthesia, corresponding dose required for induction of anaesthesia for both induction doses), EC50 using BIS, required doses of Propofol during maintenance of anaesthesia, wake-up time. Nature and extent of the burden and risks associated with participation benefit and group relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling arterial line. The patient will be asked to count slowly during induction of anaesthesia. Both induction doses of 200 and 350 milligrams are currently used standard induction doses for morbidly obese patients.
NCT00446420 ↗	Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations	Completed	Melbourne Health	Phase 4	2007-02-01	Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects. 200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

Clinical Trial Conditions for DIPRIVAN

Condition Name

Condition Name for DIPRIVAN
Intervention	Trials
Anesthesia	16
Delirium	8
Pain	6
Obesity	4

Condition MeSH

Condition MeSH for DIPRIVAN
Intervention	Trials
Delirium	12
Sleep Apnea Syndromes	7
Sleep Apnea, Obstructive	6
Depression	4

Clinical Trial Locations for DIPRIVAN

Trials by Country

Trials by Country for DIPRIVAN
Location	Trials
United States	80
China	9
Egypt	9
Canada	6
Japan	3

Trials by US State

Trials by US State for DIPRIVAN
Location	Trials
California	9
New York	9
North Carolina	7
Texas	6
Pennsylvania	6

Clinical Trial Progress for DIPRIVAN

Clinical Trial Phase

Clinical Trial Phase for DIPRIVAN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	54
Phase 3	16

Clinical Trial Status

Clinical Trial Status for DIPRIVAN
Clinical Trial Phase	Trials
Completed	79
Unknown status	19
Terminated	15

Clinical Trial Sponsors for DIPRIVAN

Sponsor Name

Sponsor Name for DIPRIVAN
Sponsor	Trials
Hospira, now a wholly owned subsidiary of Pfizer	4
Merck Sharp & Dohme Corp.	4
Hospira, Inc.	4

Sponsor Type

Sponsor Type for DIPRIVAN
Sponsor	Trials
Other	186
Industry	30
U.S. Fed	4

Diprivan (Propofol) Clinical Trials Update, Market Analysis, and Exclusivity-Driven Launch Projections

Last updated: July 28, 2026

Diprivan is a branded propofol for anesthesia and procedural sedation. Its competitive and regulatory dynamics in the US and major markets are driven by (i) generic/similar availability, (ii) safety-related labeling and REMS-like operational constraints in some jurisdictions, and (iii) formulation and packaging IP rather than “new drug” pipeline milestones. A single-brand, “propofol originator” market is therefore not an R&D-to-revenue pipeline story. It is an IP-lite, supply-and-formulation story.

What is Diprivan and what uses drive demand?

Diprivan is propofol, an intravenous anesthetic agent used for:

• Induction and maintenance of general anesthesia
• Procedural sedation (non-ventilated patients in controlled settings)
• Sedation for mechanically ventilated patients in the ICU (where local labeling allows)

Demand is correlated with:

• Surgical volumes (elective and inpatient)
• Endoscopy and procedural sedation capacity
• ICU sedation utilization
• Anesthesia practice patterns and formulary decisions for sedation agents

Which dosage forms and strengths matter commercially?

Commercial evaluation typically focuses on:

• Vial presentations and concentration choices (formulary-dependent)
• Dedicated sedation anesthesia formats where available (country dependent)
• Emulsion stability, packaging convenience, and substitution rates versus generics/similars

What does the clinical trial landscape for propofol look like right now?

A “clinical trials update” for Diprivan is, in practice, a clinical evidence update for propofol products, because the active ingredient is long-established and most newer studies are comparative, dose-sparing, protocol-optimization, or safety-focused. The most decision-relevant trial categories are:

• Comparative anesthesia/sedation trials vs ketamine, etomidate, dexmedetomidine, midazolam, and inhaled approaches
• ICU sedation studies evaluating sedation targets and weaning workflows
• Pharmacokinetic and pharmacodynamic optimization studies (infusion regimens, target-controlled infusion, and population PK)
• Safety and tolerability studies, including hemodynamics, injection pain mitigation strategies, and aspiration-related risk mitigation
• Formulation comparability studies (emulsion stability, allowable concentration ranges, and bioequivalence for generics/similars)

Are there active “Diprivan-specific” pivotal trials that shift market share?

No. For a long-cycled active ingredient like propofol, the commercial swing typically comes from:

• Formulary access for specific branded SKUs vs generics
• Product availability and distribution economics
• Labeling updates that change sedation/anesthesia practice
• Litigation or exclusivity-driven “brand moat” that delays generics entry

If a “Diprivan brand-maintenance” clinical program exists, it rarely creates a new regulatory pathway or a materially different indication in a way that changes the substitution curve at scale. The market is instead managed through product lifecycle and procurement.

Which patents protect Diprivan propofol products and what is the expiration timeline?

For Diprivan, protection is generally not anchored to active-ingredient novelty, because propofol patent coverage dates from the original development era. The remaining patentable territory tends to be:

• Formulation-specific patents (emulsion composition details, stabilizers, surfactant systems)
• Packaging and device-related patents (if tied to a specific delivery system)
• Manufacturing/process patents
• Method-of-use patents tied to specific procedural sedation/anesthesia protocols (jurisdiction dependent)

When does Diprivan lose exclusivity and can generics enter freely?

In the US, entry is controlled via Orange Book listings for specific Diprivan NDA products and any unexpired patents or periods of exclusivity tied to those listings. Practically:

• For most jurisdictions, propofol is widely generically available.
• Brand retention persists where formulations, packaging, and procurement barriers slow substitution.

Market implication: Even if remaining patents exist for particular Diprivan SKUs, the market is already exposed to extensive generic competition, which compresses brand pricing. Any residual exclusivity delay typically changes share at the margin rather than preventing long-term erosion.

What is the Orange Book status of Diprivan and how does it affect generic entry risk?

Orange Book status determines whether a filer must submit Paragraph IV certifications (US Hatch-Waxman route) or can rely on non-infringement/expiration. The key driver for business risk is:

• Whether Diprivan has active listed patents for the specific NDA and dosage form
• Whether those patents are method-of-use vs formulation vs process
• Whether a “skinny label” pathway exists once patents lapse

Generic entry risk pattern: In mature propofol markets, risk is typically not “whether generics can enter.” It is “how fast and at what price,” based on:

• Supply capacity of generic manufacturers
• Contracting and tender decisions by hospitals and GPOs
• Any SKU-specific barriers (packaging, concentration, or handling constraints)
• Local regulatory review and labeling alignment

What patent litigation affects Diprivan and what are the most likely outcomes?

In mature active-ingredient categories, litigation outcomes tend to be:

• Early settlements that permit design-around products
• Launch timing adjustments tied to specific listed patents
• Limited injunction scope where patents cover formulation or packaging but not the active ingredient or the core indication

Business reality: For Diprivan, the litigation impact usually shows up as delayed SKU substitution rather than a long-duration injunction that preserves brand economics.

How do propofol brands and generics compete: market share and pricing dynamics?

Propofol competition is characterized by:

• High substitutability based on active ingredient identity and equivalent clinical performance
• Procurement-driven switching in hospitals
• Concentration and presentation selection to minimize waste and administrative friction

What market levers move revenue for Diprivan?

• Hospital contracting: GPO access and national formulary inclusion
• Availability and fill-rate reliability (stock-outs change purchasing behavior)
• Pricing strategies: pass-through pricing pressure from generics
• Training and protocol adoption: sedation workflow familiarity

Clinical and regulatory factors that shape adoption and demand

Safety and administration constraints affect utilization rates more than marginal clinical superiority.

Key operational factors that drive adoption include:

• Injection pain and patient comfort management expectations
• Hemodynamic monitoring norms
• Sedation monitoring requirements and staffing levels
• ICU sedation protocol alignment

Does REMS-like oversight materially affect Diprivan utilization?

In the US, propofol typically does not have a classic branded REMS program for all markets, but practice-level controls can mimic REMS impact through:

• Product handling requirements and training expectations
• Facility-level credentialing and monitoring standards

These controls affect throughput and institutional willingness to standardize around a specific brand SKU.

Market projection: what growth to expect for Diprivan over the next 5–10 years?

Because propofol is mature and already broadly genericized, growth is constrained by substitution. Projections should be framed as:

• Volume growth: tied to procedure volumes and sedation demand growth
• Value growth: constrained by generic price erosion and tender cycles
• Brand share: stabilized by supply reliability and SKU-specific formulary preference, then gradually pressured

Scenario-based projection (directional)

Use three scenarios driven by exclusivity/formulation and procurement:

1) Base case (most likely):

• Propofol market volume rises with surgical and ICU sedation demand.
• Diprivan brand share declines slowly or stabilizes at a lower level depending on national contracting.
• Revenue grows at or modestly above inflation; pricing pressure remains the dominant force.

2) Downside case (faster substitution):

• Competitive tender cycles accelerate substitution for Diprivan SKUs.
• More aggressive generic entry or improved generic supply reduces procurement friction.
• Revenue declines in nominal terms despite volume growth.

3) Upside case (SKU resilience and supply advantage):

• Diprivan retains preferred status in key accounts.
• Better availability and lower stock-out risk preserves contracted share.
• Packaging or formulation differentiation slows switching in select hospital systems.

What metrics to track for projection accuracy

• US and EU reimbursement/formulary changes
• Tender outcomes and GPO contract renewals
• Generic penetration at the hospital account level (share of propofol spend)
• Product availability and manufacturing continuity
• Any labeling changes affecting procedural sedation workflows

How do propofol competitors compare with Diprivan: what threatens share?

Threat is typically generic propofol equivalents and alternative sedatives rather than another brand propofol.

• Generic propofol: direct price and procurement competition
• Alternatives for procedural sedation: ketamine, dexmedetomidine, midazolam-based regimens, depending on patient population and setting
• Anesthesia protocols: inhaled anesthetics and regional techniques reduce propofol proportion in some pathways

Commercial benchmark: what matters for substitution

Substitution accelerates when:

• The generic has equivalent labeling and is accepted without extra training
• Packaging reduces administration complexity for nursing teams
• Supply is consistent
• Liability concerns about sedation safety do not shift the institution’s preference away from a specific vendor

Key takeaways

• Diprivan is an established propofol brand; most “clinical trial updates” are comparative/safety/protocol studies that do not reset the product lifecycle.
• Brand economics are primarily shaped by generic penetration, hospital contracting, and SKU-specific formulation/packaging access rather than new clinical indications.
• Patent protection, where remaining, is typically formulation/packaging/process or narrow method-of-use and is unlikely to prevent broader propofol generic availability.
• Market growth is volume-led but value-constrained; projections should assume continued pricing pressure with possible share stabilization in accounts that prioritize supply reliability and preferred SKUs.

FAQs

1. Do propofol generics have the same sedation monitoring requirements as Diprivan?
2. What formulation or packaging differences most affect hospital substitution of propofol products?
3. How do GPO contracts typically change branded propofol share over time?
4. What labeling updates for procedural sedation most impact propofol utilization?
5. Does competition from dexmedetomidine or ketamine reduce propofol demand in ICU sedation?

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References

1. FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA drug labeling for Diprivan (propofol) and key propofol products. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. Studies evaluating propofol for anesthesia and procedural sedation.