CLINICAL TRIALS PROFILE FOR DILAUDID-HP

505(b)(2) Clinical Trials for DILAUDID-HP

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

All Clinical Trials for DILAUDID-HP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00175357 ↗	NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2005-03-01	The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00175357 ↗	NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction	Completed	University of British Columbia	Phase 3	2005-03-01	The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00195910 ↗	Safety and Efficacy Study of Hydromorphone and Morphine	Completed	Chang, Andrew, M.D.	Phase 2	2004-10-01	To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
NCT00195910 ↗	Safety and Efficacy Study of Hydromorphone and Morphine	Completed	Montefiore Medical Center	Phase 2	2004-10-01	To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

Clinical Trial Conditions for DILAUDID-HP

Condition Name

Condition Name for DILAUDID-HP
Intervention	Trials
Pain	28
Acute Pain	12
Pain, Postoperative	9
Analgesics, Opioid	4

Condition MeSH

Condition MeSH for DILAUDID-HP
Intervention	Trials
Acute Pain	21
Pain, Postoperative	14
Opioid-Related Disorders	7
Emergencies	6

Clinical Trial Locations for DILAUDID-HP

Trials by Country

Trials by Country for DILAUDID-HP
Location	Trials
United States	99
Canada	13

Trials by US State

Trials by US State for DILAUDID-HP
Location	Trials
New York	25
Ohio	9
California	8
Texas	7
Maryland	6

Clinical Trial Progress for DILAUDID-HP

Clinical Trial Phase

Clinical Trial Phase for DILAUDID-HP
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	30
Phase 3	24

Clinical Trial Status

Clinical Trial Status for DILAUDID-HP
Clinical Trial Phase	Trials
Completed	63
Terminated	13
Recruiting	9

Clinical Trial Sponsors for DILAUDID-HP

Sponsor Name

Sponsor Name for DILAUDID-HP
Sponsor	Trials
Montefiore Medical Center	13
Alza Corporation, DE, USA	11
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for DILAUDID-HP
Sponsor	Trials
Other	116
Industry	25
NIH	12

Last updated: July 26, 2026

Dilaudid-HP (hydromorphone) clinical trials update, market analysis, and projection for 2025–2035

Executive summary: Dilaudid-HP (hydromorphone hydrochloride, opioid analgesic; often discussed as an immediate-release, high-potency hydromorphone formulation) remains a steady-market product driven by acute and perioperative pain management and opioid substitution from other short-acting opioids. Public, registrant-level clinical-trial and forecast granularity for a specific “Dilaudid-HP” brand version depends on how trials and labeling are tied to the marketed product. Without a verifiable, brand-specific clinical-trial set and current FDA/Orange Book identifiers for “Dilaudid-HP” in the public record, a complete, litigation-grade projection for the brand cannot be produced from reliable sources.

What clinical trials involve Dilaudid-HP (hydromorphone hydrochloride) in 2024–2026?

Featured snippet answer: A brand-specific “Dilaudid-HP” clinical-trial portfolio cannot be confirmed from the public record without mapping the exact marketed dosage form/strength and label to trial registry entries. Hydromorphone trials exist for pain indications, routes, and comparative opioid effectiveness, but tying those trials to “Dilaudid-HP” requires product-specific identifiers (NDC/labeling and trial sponsor mapping).

Which indications are most common for hydromorphone trials?

• Acute pain and perioperative analgesia (post-op pain control)
• Cancer pain and breakthrough pain studies (in broader hydromorphone program literature)
• Opioid-switch or comparative effectiveness across short-acting opioids
• Route and formulation performance studies (oral vs. IV vs. patient-controlled analgesia)

What endpoints are used in hydromorphone pain studies?

• Time to meaningful pain relief
• Pain intensity difference (baseline to post-dose)
• Rescue medication use
• Safety endpoints: respiratory depression signals, sedation, vomiting, constipation, hypotension
• Abuse-deterrence and misuse-related endpoints when studied (less common for IR oral hydromorphone brand programs)

How big is the Dilaudid-HP market, and who drives demand?

Featured snippet answer: Hydromorphone in the US is used heavily in hospital settings for acute and perioperative pain. Brand-level market sizing for “Dilaudid-HP” specifically cannot be verified without confirming the exact product listing(s) that “Dilaudid-HP” refers to (NDC-level) and isolating those from broader hydromorphone immediate-release market totals.

Demand drivers

• Hospital surgical volume and post-anaesthesia pain protocols
• Opioid rotation patterns (substitution from morphine or oxycodone products when tolerated better)
• Formularies and anesthesia/pain-service prescribing patterns
• Procurement contracts and wholesaler buying cycles

Competitive set (category-level)

• Other short-acting opioids for acute pain: morphine IR, oxycodone IR, hydrocodone combinations (where permitted)
• Hospital-use alternatives: IV opioids, fentanyl formulations, and PCA pathways (institution-specific)

When does hydromorphone product exclusivity expire, and how does it affect Dilaudid-HP revenue?

Featured snippet answer: Immediate-release hydromorphone products in the US are largely exposed to generic competition. Brand revenue trajectory typically depends less on exclusivity for the active ingredient and more on label differentiation, manufacturing/quality positioning, supply continuity, and REMS or risk-management implementation where applicable.

What typically determines brand survival for short-acting opioids?

• Generic count and pricing pressure
• WAC-to-net discount dynamics and payer mix
• Hospital formulary preference and contracting
• Safety communication updates and label changes

What is the FDA status and Orange Book listing for Dilaudid-HP?

Featured snippet answer: FDA/Orange Book status cannot be stated for “Dilaudid-HP” as a distinct brand product without the exact product identifiers (active ingredient salt, dosage form description, strength, and Orange Book application number). Hydromorphone products are present in the Orange Book as generic equivalents for most strengths and dosage forms, but brand-level “Dilaudid-HP” listing details are required to report accurately.

What to check in Orange Book for hydromorphone brands

• Drug substance and drug product application numbers
• Patent codes and expiration dates
• Exclusivity codes (where listed) by applicant

What Paragraph IV challenges or opioid-supply litigation affect Dilaudid-HP?

Featured snippet answer: A brand-specific litigation and Paragraph IV record for “Dilaudid-HP” cannot be produced without confirming the Orange Book NDC/ANDA mapping to the branded product at issue. Hydromorphone has had broader class litigation and opioid-supply litigation historically, but that does not translate into a controllable IP or FDA-ANDA risk profile for a single branded version.

How litigation impacts short-acting opioid brands

• Injunction risk and launch delays for authorized generics
• Court-ordered stays affecting FDA approval timelines
• Settlement terms that can include supply and licensing structures

How does Dilaudid-HP compare with other hydromorphone products and immediate-release opioids?

Featured snippet answer: Category-level comparison hinges on formulation and delivery system (IR oral vs. IV vs. patient-controlled approaches), onset and titration behavior, and institutional preference. Without the exact Dilaudid-HP dosage form and strength mapping, meaningful product-to-product differentiation cannot be quantified.

Comparison dimensions that move procurement decisions

• Bioavailability consistency and variability across patient populations
• Titration flexibility and dosing increments
• Administration workflow fit for hospital pharmacy
• Conversion guidance from other opioids (clinical protocols and order sets)

How many patents protect hydromorphone immediate-release products, and what is the patent expiration timeline?

Featured snippet answer: A hydromorphone IR patent estate for a single brand version cannot be quantified without confirmed Orange Book patent listings and patent numbers tied to that exact product. In practice, hydromorphone IR has extensive generic penetration, which tends to reduce the relevance of long, brand-held patent fences for revenue protection.

What a full patent estate review normally includes

• Composition-of-matter patents on salt forms or polymorphs (if claimed)
• Formulation patents (granulation, coatings, sustained release not expected for IR)
• Method-of-use patents (rare for basic analgesic indications but possible)
• Packaging and manufacturing process patents

What generic entry risks exist for Dilaudid-HP, and what would trigger a launch?

Featured snippet answer: Generic entry risk depends on the applicable Orange Book patent and exclusivity status for the exact branded dosage form. For widely genericized hydromorphone IR, most risk is already realized; incremental changes typically come from new strengths, new NDA labeling updates, supply outages, or enforcement-driven market exits and re-entries.

Launch triggers typically include

• ANDA approval after patent expiry or carve-outs
• Authorized generic arrangements
• Court dismissals or settlements ending stays
• Manufacturing site readiness and scale-up for demand surges

Market projection: base case and sensitivities for Dilaudid-HP (2025–2035)

Featured snippet answer: Brand-level projection cannot be calculated from reliable inputs for “Dilaudid-HP” specifically without confirmed market sizing, product identifiers, and a traceable clinical and regulatory record. A defensible projection requires isolating Dilaudid-HP from broader hydromorphone totals and mapping its forecast drivers to that exact NDC/label.

Projection framework (what materially moves the number)

• Pricing pressure from generics and authorized generics
• Volume stability driven by perioperative volumes and hospital formularies
• Patient acuity and opioid stewardship policy shifts (conversion to other opioids, non-opioid multimodal regimens)
• Supply disruptions and contracting cycles
• Label and safety communications that shift prescribing

Base case dynamics for hydromorphone IR brands

• Volume tends to be resilient in acute-care settings
• Net price typically erodes over time as generic competition intensifies
• Margin outcomes depend on net-to-WAC spreads and product mix

Key takeaways

• “Dilaudid-HP” brand-specific clinical-trial scope, FDA/Orange Book identifiers, and patent and litigation landscape cannot be verified with enough precision to support a complete, high-stakes market projection.
• Hydromorphone market demand is anchored in acute and perioperative pain management and hospital prescribing patterns, but brand-level forecasting requires mapping the exact product version to FDA listings and trial registry entries.
• For revenue and launch-risk decisions, the decisive inputs are the Orange Book patent/exclusivity mapping at the NDC level and any ANDA litigation tied to those exact listings.

FAQs

1. How do hydromorphone immediate-release prices typically move after generic launches in the US?
2. Which hydromorphone clinical trials most influence hospital formulary decisions for acute pain?
3. What endpoints do regulators and payers prioritize for opioid analgesic acute-use products?
4. How does opioid stewardship policy affect short-acting hydromorphone utilization trends?
5. What Orange Book fields determine whether an ANDA can launch for hydromorphone IR products?

References

(No sources can be cited without verifiable, brand-specific identifiers and a confirmable public record mapping to “Dilaudid-HP”.)