CLINICAL TRIALS PROFILE FOR DILAUDID

505(b)(2) Clinical Trials for DILAUDID

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

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.

Clinical Trial Conditions for DILAUDID

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for DILAUDID

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for DILAUDID

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for DILAUDID

Sponsor Name

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

Sponsor Type

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

Dilaudid (hydromorphone) clinical trials update, market analysis, and exclusivity-to-generic projection

Last updated: July 28, 2026

Dilaudid is an innovator branded formulation of hydromorphone HCl (an opioid analgesic). Patent-expiration and generic-entry dynamics for “Dilaudid” are not driven by a single recent blockbuster R&D event; the market is structurally shaped by (1) long-established hydromorphone immediate-release (IR) and extended-release (ER) product lineages, (2) FDA-controlled opioid labeling and REMS-like risk controls (where applicable), and (3) state-level opioid prescribing and enforcement.

Because “Dilaudid” is a legacy brand, the most decision-relevant items for business teams are: (a) what exact dosage forms are being targeted (IR tablets, ER, solution), (b) what Orange Book listings and manufacturing processes are still protecting the specific NDA/strength, and (c) whether any new clinical programs are being run for non–immediate-release uses (abuse-deterrent, novel delivery, combinations).

Which patents protect Dilaudid (hydromorphone) formulations, methods of use, and manufacturing?

Answer (featured snippet): Dilaudid protection is typically a patchwork of old composition/formulation and method-of-use IP tied to specific NDA/strength/dosage forms. Hydromorphone’s active ingredient is long off patent; current exclusivity and remaining patent value is usually concentrated in product-specific reformulations, abuse-deterrence, and manufacturing process claims rather than the core API.

What patent estate is most relevant for a “Dilaudid” market entrant?

For market entry planning, focus on three layers:

1. Formulation and delivery patents: controlled release matrices, coating systems, or IR excipient systems that enable specific release profiles or physicochemical properties.
2. Abuse-deterrent technology (ADT): physical/chemical barriers, extraction resistance, or tamper-resistant mechanisms, if the marketed product has ADT.
3. Manufacturing process patents: granulation, compression, coating, or solvent/water handling steps tied to impurity control and stability.

How many patents cover “Dilaudid” across jurisdictions?

Without the specific NDA/strength and product form, a complete count across Orange Book and global filings cannot be produced.

What companies typically hold and/or challenge hydromorphone IP?

Historically, hydromorphone branded holders and large generics often litigate around:

• delayed-release or ER versions (where present),
• bioequivalent equivalence vs. formulation claims, and
• manufacturing-related IP.

A defensible, litigation-grade mapping requires product-form specificity (IR vs ER vs solution) and Orange Book listing IDs.

When does Dilaudid lose exclusivity and when can generics launch?

Answer (featured snippet): For legacy hydromorphone brands, exclusivity is usually driven by (i) last patent expiry for the exact dosage form strength and (ii) any product-specific exclusivities (if any) tied to that NDA. Generic availability is often already present for many strengths and routes, while remaining protected entries tend to be narrower (specific form, specific release mechanism, or specific labeling).

What are the practical exclusivity drivers for hydromorphone brand products?

• Orange Book-listed patents: composition, formulation, and method-of-use.
• Patent expiration vs. FDA “data exclusivity”: FDA exclusivity can delay generic approvals even after patent status, depending on the NDA approval pathway and changes.
• Switch-over and labeling: some products remain protected due to reformulation, strength changes, or REMS-related labeling updates tied to the branded NDA.

ER vs IR: why the timeline differs

ER hydromorphone products often carry different risk than IR tablets/solution. If a protected ER formulation exists under a still-active patent set, entry timing can be delayed even when IR strengths are widely generic.

What Orange Book status does Dilaudid have for tablets, solution, and extended-release?

Answer (featured snippet): Dilaudid Orange Book status is product- and strength-specific and must be checked against the NDA(s) covering the marketed dosage forms. Hydromorphone as an API is widely generic. The only decision-grade determination is whether a given NDA/strength still lists active patents and/or enforceable exclusivities.

How to interpret Orange Book entries for “Dilaudid”

For any targeted launch, teams typically evaluate:

• active vs expired listed patents,
• whether patents are tied to “drug product” or “drug substance,”
• whether listed patents cover “use claims” that generic labeling must avoid or “carve out,” and
• whether the listed patents align with the dosage form the generic intends to market.

What clinical trials update exists for Dilaudid (hydromorphone) in 2024–2026?

Answer (featured snippet): No recent, high-signal clinical-trial readouts define “Dilaudid” as an R&D growth platform in the way current-generation opioid delivery technologies do. Hydromorphone clinical activity in recent years has more often been in the form of formulation bioequivalence studies for generics, or in smaller mechanistic/optimization studies, rather than large Phase 3 brand-defining programs.

Where trial activity is most likely to appear

Hydromorphone-focused studies in trial registries commonly cluster in:

• cancer pain and breakthrough pain settings,
• opioid rotation and titration protocols,
• abuse-deterrent or tamper-resistance evaluations for hydromorphone-containing products, and
• ER vs IR comparative pharmacokinetic work.

What would change the market outlook

A meaningful Dilaudid market shift would require:

• a new NDA for an improved delivery or ADT product with a non-hydromorphone competitor gap,
• a new combination or indication expansion that triggers a new exclusivity period, or
• a regulatory approval that repositions the brand’s competitive advantage (for example, a new ER abuse-deterrent profile).

No such brand-defining, late-stage breakthrough can be stated from the provided prompt alone.

What formulations are protected by Dilaudid patents?

Answer (featured snippet): Protection, when it remains, is concentrated in specific formulation systems tied to the branded dosage form: IR tablet/excipients, ER matrix/coating, or solution-specific properties like viscosity and impurity profile.

IR tablets vs ER: what claims usually cover

• IR tablets: excipient systems and impurity specs; sometimes particle size and blending steps.
• ER: polymer matrix or coating, release control layers, and manufacturing controls to achieve defined release kinetics.

Abuse-deterrence (ADT) angle

If the marketed Dilaudid product has ADT features, the most litigated claim categories are typically mechanical tamper-resistance and extraction resistance.

What patent litigation affects Dilaudid and generic entry?

Answer (featured snippet): Hydromorphone brand and product line IP disputes have historically centered on Orange Book-listed patents for specific dosage forms and strengths. The risk to generic entry is strongest when a Paragraph IV notice challenges a still-active formulation or method-of-use patent set tied to the intended product.

How Paragraph IV filings translate into launch timing

• If a generic challenges a patent that is ultimately held valid and infringed, launch can be blocked.
• If the generic prevails or the NDA holder does not obtain or enforce an injunction, entry can proceed soon after relevant regulatory timelines (and patent/market exclusivity triggers).

Litigation status needed for a defensible projection

A launch projection requires:

• the identity of the specific Dilaudid NDA and strength,
• Orange Book patent numbers tied to that NDA, and
• the status of any Paragraph IV cases.

Those identifiers are not present in the prompt.

How does Dilaudid compare with alternative hydromorphone products and opioid competitors?

Answer (featured snippet): Dilaudid competes in the hydromorphone analgesic segment and in the broader opioid analgesic segment. Market share and pricing are shaped by formulary placement (managed care), abuse-deterrent preferences, and hospital/IDN contracting rather than by superior clinical efficacy.

Competitive set (typical)

• Generic hydromorphone IR tablets/solution widely available across strengths.
• Other opioid analgesics with stronger institutional preference due to ADT profiles, payer rules, or formulary history.
• ER opioids where ER abuse-deterrence or dosing convenience changes adoption.

What generic entry risks exist for Dilaudid?

Answer (featured snippet): Generic entry risk is low for the hydromorphone API itself, but can be non-trivial for any remaining protected branded dosage form strengths, especially if the NDA still lists active formulation or method-of-use patents.

What to measure for entry probability

• Remaining active Orange Book patents (drug product and use claims).
• Whether a generic applicant must “design around” formulation or label to avoid infringement.
• Whether the NDA holder has a history of enforcing narrower process/formulation claims.

What is the market analysis and revenue projection for Dilaudid?

Answer (featured snippet): Dilaudid’s revenue trajectory is constrained by generic substitution across many hydromorphone dosage forms and the steady expansion of available generics. Market growth, where it exists, tends to come from (i) shifts in prescribing from other opioids, (ii) ER adoption for appropriate patients, and (iii) localized payer and hospital formulary dynamics.

Market sizing approach for projection (what matters)

A credible projection needs these inputs:

• current total hydromorphone unit share by dosage form (IR vs ER vs solution),
• brand vs generic split for the exact “Dilaudid” product NDA,
• net price evolution (contracting, discounting, channel mix),
• opioid utilization trends affected by controlled substance policies,
• loss of exclusivity events for any remaining protected strengths.

The prompt does not provide product-form and historical sales baselines, so a numeric forecast cannot be produced without fabricating data.

Price and channel factors that typically drive hydromorphone branded decline

• Generic penetration reduces WAC-to-net pricing.
• Contracting and PBM rebates accelerate substitution.
• Increased scrutiny of opioid prescribing reduces overall volume growth.

What manufacturing/IP barriers could block generic substitution?

Answer (featured snippet): For hydromorphone generics, barriers are usually not the API synthesis. They are formulation/process patent claims, ANDA manufacturing controls that maintain impurity profiles, and label/carve-out requirements if method-of-use patents exist.

Key barrier types

• Coating/matrix IP for ER versions
• Impurity-spec manufacturing process constraints (process claims)
• Labeling carve-outs required to avoid infringement of use claims

Key Takeaways

• Dilaudid’s market position depends on which specific dosage form and NDA/strength is being evaluated. Hydromorphone’s API is long generic; remaining value is usually in product-specific formulation/process patents and any active method-of-use claims.
• Exclusivity-to-generic timing is controlled by Orange Book status for the exact Dilaudid product, not by hydromorphone broadly.
• Clinical-trial momentum for “Dilaudid” as a brand-defining late-stage program is not evident from the prompt; most visible hydromorphone activity is incremental, including formulation and PK-focused studies.
• Defensible market projection requires exact product identifiers and current sales baselines; otherwise numeric forecasts would be speculative.

FAQs

1. Which Dilaudid dosage forms (IR tablets vs ER vs solution) still have Orange Book-listed active patents?
2. Can generics launch Dilaudid-strength tablets while avoiding formulation patents through a different release profile?
3. Do hydromorphone abuse-deterrent requirements affect ANDA approval timelines and labeling?
4. How do Paragraph IV settlements typically alter launch dates for legacy opioid brands like Dilaudid?
5. What endpoints in hydromorphone clinical trials (pain scores vs PK) are most likely to support label expansions or reforms?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. FDA. Drug Trials Snapshots and clinical trial listings on Drug.gov. FDA.
3. ClinicalTrials.gov. Hydromorphone-related studies (search results). National Library of Medicine.