CLINICAL TRIALS PROFILE FOR FENTANYL-62

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505(b)(2) Clinical Trials for FENTANYL-62

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).
New Formulation	NCT01717157 ↗	A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers	Completed	Janssen Research & Development, LLC	Phase 1	2012-08-01	The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.

All Clinical Trials for FENTANYL-62

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.
NCT00027014 ↗	Herb-Opioid Interactions	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-09-01	This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.

Clinical Trial Conditions for FENTANYL-62

Condition Name

Condition Name for FENTANYL-62
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

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

Clinical Trial Locations for FENTANYL-62

Trials by Country

Trials by Country for FENTANYL-62
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-62
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for FENTANYL-62

Clinical Trial Phase

Clinical Trial Phase for FENTANYL-62
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for FENTANYL-62
Clinical Trial Phase	Trials
Completed	962
Recruiting	315
Unknown status	195

Clinical Trial Sponsors for FENTANYL-62

Sponsor Name

Sponsor Name for FENTANYL-62
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for FENTANYL-62
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Last updated: July 28, 2026

Fentanyl-62 clinical trials update, market analysis, and sales projection

Executive summary: No complete, verifiable public dossier was identified for a drug entity explicitly named “Fentanyl-62” (active ingredient, salt/ester, specific formulation, sponsor, FDA application, clinicaltrials.gov record, or marketing authorization record). Without a definable regulatory and clinical anchor, a complete and accurate clinical-trials update, competitive landscape, and market/sales projection cannot be produced under an evidence-based patent and regulatory framework.

What is “Fentanyl-62” and what drug is it (API, salt, and formulation)?

A market and clinical update requires identification of the exact product: active ingredient (fentanyl base vs specific derivative), salt/ester form, dosage form (eg, transdermal, buccal, sublingual, injectable), strength, and route. A drug labeled “Fentanyl-62” does not map to a distinct, consistently indexed pharmaceutical product name in standard regulatory and clinical registries based on the information provided.

Which fentanyl variant does “62” refer to?

Fentanyl product naming in public sources typically ties to:

• branded proprietary names (not numeric suffixes),
• regulatory application identifiers,
• specific delivery system names (eg, matrix types, reservoir systems),
• or known salt forms (eg, fentanyl citrate, fentanyl hydrochloride) and dosage forms.

Is it a reformulation, new delivery system, or new chemical entity?

Market projections diverge sharply by IP and regulatory pathway:

• reformulation/delivery system changes create formulation patent clusters and may limit AB-rating competition,
• new salt/strength can unlock specific exclusivity,
• new indication can extend clinical value without new regulatory approval pathways,
• new entity affects the exclusivity timeline and payer adoption curve.

What clinical trials exist for Fentanyl-62 and what are the latest results?

A clinical-trials update requires:

• sponsor identity,
• trial registry IDs (eg, NCT numbers),
• enrollment status (recruiting/active/not recruiting),
• endpoints (PK/PD, analgesic efficacy, safety),
• and last update dates.

No verifiable clinical trial record can be tied to a distinct investigational product named “Fentanyl-62” from the information available here, so a results timeline would be speculative.

Which endpoints matter for fentanyl analogs or new delivery systems?

For fentanyl-related development programs, typical Phase 1 to Phase 3 endpoints include:

• PK parameters (Cmax, Tmax, AUC),
• onset time and analgesia time course,
• respiratory depression incidence,
• tolerability and abuse-deterrence relevant safety signals (if applicable).

How would approvals be positioned in FDA pathways?

Fentanyl product development commonly uses:

• 505(b)(1) for reformulations or bridging strategies,
• 505(b)(2) where reliance on literature or reference product data applies,
• or NDA/ANDA dynamics depending on whether the product is “generic-like” vs innovative.

Without a product anchor, the pathway cannot be assigned.

How big is the fentanyl market exposure and where does Fentanyl-62 fit?

A credible market analysis requires:

• target geography (US, EU, Japan, etc.),
• patient population (cancer pain, breakthrough pain, postoperative, chronic pain, opioid use disorder adjuncts, etc.),
• comparator set (current standard-of-care fentanyl delivery systems),
• reimbursement and payer posture.

Fentanyl is a mature and heavily regulated category with strong payer and REMS-style considerations for misuse risk and respiratory safety. But “Fentanyl-62” cannot be placed into a concrete market segment without knowing route, strength, and intended use.

What segments drive growth for fentanyl products?

Key segments that typically drive volume include:

• breakthrough cancer pain products,
• opioid rotation and high-risk patient management workflows,
• hospital formularies for perioperative analgesia.

What does pricing power depend on?

Pricing and adoption depend on:

• demonstrated speed of onset,
• safety profile (respiratory depression, sedation),
• ease of use (device usability, dosing accuracy),
• and abuse-deterrent performance if claimed.

When does Fentanyl-62 lose exclusivity and what patents protect it?

A patent expiration and exclusivity schedule requires:

• application/publication numbers,
• Orange Book listings (if approved in US),
• and relevant patent families (composition, formulation, method of use, manufacturing).

No Orange Book or patent estate can be reliably mapped to “Fentanyl-62” without an identified NDA/BLA/ANDA and reference product link.

Which exclusivity types typically apply to fentanyl products?

Depending on the approval posture:

• New Chemical Entity exclusivity (if truly a new active),
• New Clinical Investigation exclusivity (if new use),
• Patent term and regulatory exclusivities tied to NDA/BLA reference records,
• Or exclusivity limitations for 505(b)(2) or incremental changes.

What is the competitive landscape for Fentanyl-62 (brands, generics, and biosimilar risk)?

For small-molecule fentanyl products:

• biosimilar risk does not apply (fentanyl is not a biologic),
• competition instead comes from label-matched generics, authorized generics, and therapeutic alternatives (other opioid classes and non-opioid adjuncts).

A competitor set must be mapped by:

• route (transdermal vs transmucosal vs injectable),
• indication (breakthrough pain vs chronic cancer pain vs other),
• and controlled-substance scheduling impacts.

No definable product identity prevents an evidence-based competitor list.

How strong are the generic entry risks for Fentanyl-62 (Paragraph IV and FDA filings)?

Paragraph IV filings are specific to ANDA contexts and require:

• an Orange Book listing for the reference drug,
• ANDA filing disclosures tied to that reference,
• and publicly available litigation dockets.

No Orange Book anchor can be connected to “Fentanyl-62” from the information available here.

What would shape ANDA feasibility for a fentanyl product?

• formulation complexity and device IP,
• bioequivalence feasibility,
• controlled substance handling and REMS-like controls (where applicable),
• and patent claim coverage on release profile or abuse-deterrence features.

What is the FDA regulatory status of Fentanyl-62?

Regulatory status requires at least one of:

• FDA Drugs@FDA listing,
• Orange Book record,
• NDA/BLA number,
• approval dates,
• labeling and CMC details.

No verifiable FDA listing can be identified here for a drug titled “Fentanyl-62.”

Sales projection for Fentanyl-62: what revenue could it generate?

A sales projection must be built from:

• addressable patient counts and dose intensity,
• market share scenarios and adoption curves,
• net pricing and discount assumptions,
• and cycle-based uptake against formulary barriers.

Without the drug’s:

• route and dosing,
• approved indication,
• US/EU launch status,
• and competitive set, any numerical projection would be non-actionable.

What inputs drive projection accuracy in fentanyl?

• payer mix (hospital vs outpatient),
• number of eligible patients per indication,
• substitution barriers vs existing fentanyl products,
• and restrictions imposed by prescriber protocols.

Key Takeaways

• No evidence-based, complete identification of a distinct drug entity named “Fentanyl-62” is possible from the provided prompt.
• Without a definable product anchor (NDA/BLA, NCT ID, Orange Book listing, salt/formulation, and route), clinical trial updates, exclusivity timelines, competitive landscape, and revenue projections cannot be produced without speculation.

FAQs

1. What does a numeric fentanyl development name usually map to in public records (e.g., delivery system code)?
2. How do market projections change between transdermal vs transmucosal fentanyl products?
3. What exclusivity mechanisms apply to opioid analgesic reformulations under FDA?
4. What evidence is typically needed for generic substitution of controlled-substance fentanyl products?
5. What regulatory milestones most strongly correlate with launch timing for opioid products?