CLINICAL TRIALS PROFILE FOR FENTANYL-50

505(b)(2) Clinical Trials for FENTANYL-50

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
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Pfizer	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Duke University	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for FENTANYL-50

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	New York State Psychiatric Institute	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00003000 ↗	Morphine for the Treatment of Pain in Patients With Breast Cancer	Completed	Roswell Park Cancer Institute		1992-05-01	RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Clinical Trial Conditions for FENTANYL-50

Condition Name

Condition Name for FENTANYL-50
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

Condition MeSH for FENTANYL-50
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51
Hypotension	47

Clinical Trial Locations for FENTANYL-50

Trials by Country

Trials by Country for FENTANYL-50
Location	Trials
United States	902
Egypt	361
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for FENTANYL-50
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-50

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-50
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-50
Clinical Trial Phase	Trials
Completed	962
Recruiting	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL-50

Sponsor Name

Sponsor Name for FENTANYL-50
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for FENTANYL-50
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Fentanyl-50 Clinical Trials Update, Market Analysis and Price/Revenue Projection (2026–2035)

Last updated: July 29, 2026

Executive summary: No complete, accurate clinical-trials, regulatory, and market dataset can be produced for “FENTANYL-50” from the information provided. “Fentanyl” is an established active ingredient with multiple marketed formulations (transdermal, oral transmucosal, injectable, and newer specialty delivery systems), and “-50” is not a unique identifier on its own for a specific FDA product, NDC, strength, salt, route, or dosage form. Without a product-identifying anchor (e.g., FDA application number, proprietary product name, dosage form/route tied to “50,” or sponsor/program label), any clinical-trials update, Orange Book status, exclusivity timetable, or revenue projection would be inconsistent and potentially incorrect.

What is “FENTANYL-50” and which fentanyl product does it refer to?

Featured snippet answer: “Fentanyl” is a controlled opioid with multiple FDA-approved product families; “FENTANYL-50” is not a universally recognized US regulatory or clinical-trials identifier. Product-specific analysis requires tying the label “FENTANYL-50” to an FDA-approved proprietary name and route/dosage form.

Which fentanyl delivery systems typically have numbered “strength” identifiers?

Fentanyl programs are commonly distinguished by:

• Transdermal patches (dose-releasing systems tied to microgram-per-hour strength)
• Oral transmucosal products (buccal tablets, sublingual tablets/films, lozenges, nasal sprays)
• Injectables (IV/IM anesthesia and procedural use)
• Specialty delivery (e.g., novel mucosal absorption systems, fast-onset rescue products)

Why “-50” matters for IP and market sizing

A “50” suffix can mean different things depending on the sponsor label:

• Strength in mg or mcg per unit (tablets, sprays, etc.)
• Patch release rate (microgram/hour)
• Device or cartridge strength
• Internal program codename

Without mapping “FENTANYL-50” to a specific formulation and route, the clinical pipeline and commercial base cannot be correctly attributed.

What clinical trials are running for fentanyl products with a “50” designation?

Featured snippet answer: A fentanyl clinical-trials update cannot be generated without correctly identifying the specific compound/program behind “FENTANYL-50,” because sponsors and investigators run trials across many fentanyl formulations and indications (breakthrough cancer pain, opioid-induced pain, perioperative anesthesia, opioid use disorder adjunctive studies, and more).

Which fentanyl trial types would normally be tracked

For a complete program update, investors typically track:

• Phase 1 pharmacokinetics and bioequivalence (for reformulations and generics)
• Phase 2/3 efficacy in target pain states
• Opioid safety and misuse-related outcomes (abuse-deterrent claims)
• Respiratory depression endpoints and risk-mitigation measures
• Pediatric-enrollment pathways and label-expansion studies

Trial registries typically used

A proper update normally pulls from:

• ClinicalTrials.gov
• EU Clinical Trials Register
• Sponsor presentations and press releases tied to the specific product name
• Conference abstracts (ASCO, PAINWeek, ACCP, Anesthesiology societies)

No product anchor is present, so no registry extraction can be performed reliably.

What is the market size and forecast for a specific “FENTANYL-50” product?

Featured snippet answer: Product-level market forecasts cannot be constructed without knowing whether “FENTANYL-50” is transdermal, oral transmucosal, injectable, or another delivery system, and without identifying the branded/proprietary name and launch geography.

Market modeling variables that require product identity

A credible forecast needs:

• Indication (breakthrough cancer pain, chronic pain, procedural analgesia, etc.)
• Dose form and route (patch vs mucosal vs IV)
• Dosing unit economics (units per prescription, WAC vs net pricing)
• Payer mix and formulary access
• Competitive set (other fentanyl SKUs, DEA scheduling-driven prescribing patterns)
• Generic and AB-rated substitution risk by route

What can be forecast at the class level vs the product level

• Class-level demand for fentanyl across indications can be approximated using public opioid and pain-market data.
• Product-level unit share and revenue cannot be projected without tying “FENTANYL-50” to a specific FDA-labeled product.

When does fentanyl “50” lose exclusivity and when could generics enter?

Featured snippet answer: Exclusivity timelines and generic entry risks are product-specific and require:

• FDA approval date and application reference
• Orange Book listings (patent numbers and expiration dates)
• Exclusivity grants (5-year New Chemical Entity, 3-year new clinical investigations, 7-year orphan where applicable)
• Patent litigation history and settlement terms

“FENTANYL-50” is not sufficiently specified to support Orange Book parsing or exclusivity computation.

What patents protect fentanyl formulations like “FENTANYL-50”?

Featured snippet answer: Patent protection for fentanyl products depends on the exact formulation, method of use, manufacturing process, and any abuse-deterrent features. A patent estate cannot be enumerated without product-identifying Orange Book data.

Patent estate components normally reviewed

• Formulation patents (polymer matrix, solubilizers, mucosal absorption enhancers)
• Method-of-use patents (dose titration, specific pain states)
• Manufacturing/process patents
• Device or delivery system patents
• Abuse-deterrent composition and tamper-resistant delivery patents

What Orange Book status does “FENTANYL-50” have and what patents are listed?

Featured snippet answer: Orange Book status cannot be verified for “FENTANYL-50” without the exact FDA proprietary product name and dosage form/strength mapping to an Orange Book record.

Is there any Paragraph IV or biosimilar-equivalent litigation for this fentanyl program?

Featured snippet answer: Paragraph IV challenges are for small-molecule ANDAs; biosimilar litigation is for biologics. Neither can be determined without knowing the exact FDA product being challenged and the relevant ANDA/bla docket(s).

How does “FENTANYL-50” compare with other fentanyl products in the same class?

Featured snippet answer: Comparison requires the specific route and formulation. A patch cannot be compared on the same basis as an oral transmucosal fentanyl product for dosing frequency, onset, and payer coverage criteria.

Key takeaways

• “FENTANYL-50” is not uniquely identifiable from the input; product-level clinical, regulatory, and market analysis cannot be produced accurately.
• Any attempt to forecast revenue, list exclusivity dates, or summarize litigation would risk misattribution across different fentanyl formulations and strengths.
• A correct update must be anchored to an FDA-identified product (proprietary name + dosage form + strength/route), then mapped to Orange Book patents, exclusivity, and clinical trial records.

FAQs

1. What information uniquely identifies a fentanyl product for Orange Book and exclusivity analysis?
2. How are fentanyl patch strength (“mcg/hour”) units translated into dosing economics and market projections?
3. What endpoints drive FDA approval of oral transmucosal fentanyl reformulations?
4. How do abuse-deterrent fentanyl formulation patents affect generic substitution risk?
5. What factors most impact payer coverage for breakthrough cancer pain fentanyl products?

References

1. ClinicalTrials.gov. (n.d.). Database entries for fentanyl studies. https://clinicaltrials.gov/
2. FDA Orange Book. (n.d.). Drug Products, Discontinued Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. (n.d.). Drug approvals and labeling resources. https://www.fda.gov/drugs