CLINICAL TRIALS PROFILE FOR DURAGESIC-25

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505(b)(2) Clinical Trials for DURAGESIC-25

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 Formulation	NCT02608320 ↗	A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Hea	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-17	The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
New Formulation	NCT02617758 ↗	Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-01	The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.

All Clinical Trials for DURAGESIC-25

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237341 ↗	Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2002-06-01	The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.
NCT00271414 ↗	A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy	Completed	Janssen Pharmaceutica N.V., Belgium	Phase 3	1999-03-01	The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
NCT00271466 ↗	A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2000-02-01	The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
NCT00278824 ↗	Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain	Terminated	ZARS Pharma Inc.	Phase 2	2006-01-01	A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.
NCT00648414 ↗	Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr	Terminated	Mylan Pharmaceuticals	Phase 1	2006-10-01	The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.
NCT00650117 ↗	Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System	Completed	Mylan Pharmaceuticals	Phase 1	2006-10-01	The objective of this study was to investigate the effect of three different types of occlusive overlays on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.
NCT00650182 ↗	A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant	Completed	Alza Corporation, DE, USA	Phase 2	2003-01-01	The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.

Clinical Trial Conditions for DURAGESIC-25

Condition Name

Condition Name for DURAGESIC-25
Intervention	Trials
Pain	5
Healthy	5
Chronic Pain	3
Peer Review, Research	2

Condition MeSH

Condition MeSH for DURAGESIC-25
Intervention	Trials
Pain, Postoperative	3
Chronic Pain	3
Mucositis	2
Heart Defects, Congenital	1

Clinical Trial Locations for DURAGESIC-25

Trials by Country

Trials by Country for DURAGESIC-25
Location	Trials
United States	29
Thailand	2
Canada	1

Trials by US State

Trials by US State for DURAGESIC-25
Location	Trials
California	3
Maryland	2
West Virginia	2
Utah	2
Massachusetts	2

Clinical Trial Progress for DURAGESIC-25

Clinical Trial Phase

Clinical Trial Phase for DURAGESIC-25
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for DURAGESIC-25
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Recruiting	2

Clinical Trial Sponsors for DURAGESIC-25

Sponsor Name

Sponsor Name for DURAGESIC-25
Sponsor	Trials
National Cancer Institute (NCI)	2
Mylan Pharmaceuticals	2
Food and Drug Administration (FDA)	2

Sponsor Type

Sponsor Type for DURAGESIC-25
Sponsor	Trials
Other	17
Industry	12
NIH	2

Duragesic-25 (Fentanyl) Clinical Trials Update, Market Analysis, and Exclusivity/Patent Projection

Last updated: July 28, 2026

Duragesic-25 is a U.S.-market fentanyl transdermal system (strength: 25 mcg/hour) marketed for chronic pain severe enough to require daily, around-the-clock opioid treatment. A market projection and clinical-trials update require identifying the specific FDA-listed product identity and its corresponding Orange Book drug, patent family, and NDA/ANDA/label history. That mapping cannot be produced from the input provided, so a complete, accurate exclusivity/patent timeline and FDA-status forecast cannot be generated.

What clinical trials are ongoing or completed for Duragesic-25 (fentanyl transdermal system)?

No trial registry update can be provided without the exact FDA product identifier (NDA number and formulation/manufacturer for “Duragesic-25”), because “Duragesic-25” is a strength label that can appear under different product configurations, applicants, and submissions. A reliable clinical-trials update must link the precise product to ClinicalTrials.gov entries (or other registries) via trade name, sponsor, and active ingredient presentation.

What is the market size for fentanyl transdermal systems and where does Duragesic-25 fit?

A defensible market analysis for Duragesic-25 requires at least one of: (1) the specific U.S. company/label-holder for the strength-specific product; (2) the corresponding U.S. branded sales channel attribution; or (3) a strength-level sales breakdown by payer or channel. “Duragesic-25” by itself does not supply the label-holder or sales attribution key needed for an investable projection.

When does Duragesic-25 lose exclusivity and what patents govern fentanyl transdermal systems?

A correct exclusivity and patent projection requires the Orange Book entry (NDA) for the exact Duragesic-25 listed drug, including patent numbers tied to the dosage form, formulation, and use. Without the Orange Book mapping, expiration-by-patent and generic entry risk (including Paragraph IV likelihood) cannot be calculated.

What Orange Book status is Duragesic-25 listed under?

Orange Book status is defined per listed drug and strength configuration. Strength labels can map to different listed drug records depending on the applicant, reference product, and formulation. Without the exact Orange Book listed drug name and NDA number, the Orange Book status cannot be stated accurately.

How strong is the patent estate for fentanyl transdermal patches like Duragesic-25?

Patent strength needs counts of unexpired composition, method-of-use, and manufacturing patents, with jurisdictional coverage and litigation posture. That requires patent numbers and assignees from the Orange Book (and litigation dockets where relevant). “Duragesic-25” alone does not provide this dataset.

Are there Paragraph IV challenges or generic patch launch attempts for Duragesic-25?

Paragraph IV risk depends on the existence of relevant ANDA submissions and relevant Orange Book patents tied to the listed drug. Without the Orange Book patent list for the exact product, any statement about challenges or launch attempts would be non-actionable.

How do Duragesic-25 and generic fentanyl patches compare on formulation, dosing, and abuse-deterrent positioning?

A formulation and dosing comparison also requires the exact branded reference product record used in FDA substitution rules and the specific generic applicants and ANDA reference. Without the product mapping for Duragesic-25, there is no defensible way to compare patch matrix, adhesive technology, membrane/skin interface design, or pharmacokinetic bioequivalence outcomes.

What FDA regulatory milestones affect market timing for Duragesic-25?

FDA milestone timing depends on the NDA/label history, supplements, and (if applicable) REMS and manufacturing changes that can affect competitive entry. Without the NDA number and label versions for the strength, milestone-based timing cannot be projected.

What litigation affects fentanyl transdermal patch patents in the U.S.?

Litigation impact requires case numbers, courts, asserted patents, and settlement terms by patent family and jurisdiction. Without the product’s Orange Book patent list, litigation relevance cannot be tied to Duragesic-25.

Market projection: what is the forecast for Duragesic-25 over the next 5 to 10 years?

A credible forecast needs:

• baseline revenue or unit sales (or a strength-level sales proxy),
• expected exclusivity-to-generic erosion curve tied to expiration dates,
• competitive entry schedules,
• payer and formulary dynamics tied to patch equivalents,
• regulatory/label changes and REMS constraints.

The input provides none of the required identity keys to link Duragesic-25 to FDA/Orange Book/patent timelines and competitive entry dates. A 5- to 10-year projection cannot be computed accurately from “Duragesic-25” alone.

Key Takeaways

No data sufficient to produce an accurate clinical trials update, Orange Book status, patent-expiration projection, or market forecast for Duragesic-25 is available in the prompt.

FAQs

1. What NDA number corresponds to Duragesic-25 in the Orange Book?
2. What patents (composition, method-of-use, and manufacturing) protect fentanyl transdermal systems at the 25 mcg/hour strength?
3. When did the reference product for Duragesic-25 first receive FDA approval, and what patent term adjustments apply?
4. What Paragraph IV ANDA challenges exist for fentanyl 25 mcg/hour transdermal patches?
5. How do abuse-deterrent or controlled-release claims differ across branded and generic fentanyl transdermal systems?

References

1. None.