DURAGESIC-50 Drug Patent Profile

Which patents cover Duragesic-50, and what generic alternatives are available?

Duragesic-50 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-50 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for DURAGESIC-50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,683
DailyMed Link:	DURAGESIC-50 at DailyMed

Recent Clinical Trials for DURAGESIC-50

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jiarong Chen, MD	Phase 4
Emory University	Phase 4
Loyola University	Phase 2/Phase 3

See all DURAGESIC-50 clinical trials

US Patents and Regulatory Information for DURAGESIC-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990	4,060,084
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990	4,588,580*PED
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990	4,144,317

EU/EMA Drug Approvals for DURAGESIC-50

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	PecFent	fentanyl	EMEA/H/C/001164PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2010-08-31
Takeda Pharma A/S	Instanyl	fentanyl	EMEA/H/C/000959Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2009-07-20
Teva B.V.	Effentora	fentanyl	EMEA/H/C/000833Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,	Authorised	no	no	no	2008-04-04
Incline Therapeutics Europe Ltd	Ionsys	fentanyl	EMEA/H/C/002715Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.	Withdrawn	no	no	no	2015-11-18
Eli Lilly and Company Limited	Recuvyra	fentanyl	EMEA/V/C/002239For the control of pain associated with orthopaedic and soft tissue surgery in dogs.	Withdrawn	no	no	no	2011-10-06
Janssen-Cilag International NV	Ionsys	fentanyl	EMEA/H/C/000612Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25

International Patents for DURAGESIC-50

See the table below for patents covering DURAGESIC-50 around the world.

Country	Patent Number	Title	Estimated Expiration
France	2567761	DISPOSITIF D'APPORT TRANSDERMIQUE POUR L'ADMINISTRATION DE FENTANYL
Japan	S6137725	SKIN ADMINISTRATION OF FENTANYL AND DEVICE
Australia	4452785
Germany	3546830	Transdermales Abgabesystem zur Verabreichung von Fentanyl (Device for delivering fentanyl across the skin)
Japan	2547726
Spain	545366

Supplementary Protection Certificates for DURAGESIC-50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831

Market Dynamics and Financial Trajectory for DURAGESIC-50

Last updated: July 30, 2025

Introduction

DURAGESIC-50 is a transdermal fentanyl patch used primarily for managing severe chronic pain in patients requiring continuous opioid analgesia. Its significance in the pharmaceutical market stems from its potent efficacy, patient compliance advantages, and corresponding regulatory and commercial considerations. Understanding its market dynamics and financial trajectory requires an in-depth analysis of demand drivers, competitive landscape, regulatory environment, pricing strategies, and emerging trends influencing revenue streams.

Market Overview

Global Market Size and Growth Outlook

The global opioid analgesics market, including transdermal patches like DURAGESIC-50, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, driven by increasing prevalence of chronic pain conditions, aging populations, and advancements in drug delivery systems [1]. The segment dedicated specifically to transdermal formulations is expanding owing to patient preference for non-invasive administration routes and improved bioavailability.

Key Market Drivers

• Rising Chronic Pain Incidence: Chronic conditions such as osteoarthritis, cancer, and neuropathic pain contribute heavily to sustained demand for potent analgesics like DURAGESIC-50.
• Aging Population: Elderly demographics in North America, Europe, and parts of Asia intensify demand due to higher chronic pain prevalence.
• Preference for Transdermal Delivery: Transdermal patches reduce gastrointestinal side effects and facilitate steady drug release, bolstering adoption in pain management protocols.
• Medical Infrastructure and Prescriber Adoption: Advances in pain management paradigms and clinical guidelines support sustained prescriptions for fentanyl patches.

Market Constraints

• Regulatory Scrutiny and Opioid Crisis: Heightened regulations, opioid misuse concerns, and legal restrictions impact manufacturing, marketing, and prescribing behaviors.
• Competition: Other high-potency opioids and alternative pain management modalities challenge DURAGESIC-50’s market share.
• Pricing Pressures: Payers and healthcare systems favor cost-effective therapies, constraining premium pricing strategies.

Competitive Landscape

Major Players

While Duragesic is marketed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), multiple generic manufacturers have introduced bioequivalent fentanyl patches, intensifying price competition. The landscape includes other transdermal opioids like buprenorphine patches and non-opioid analgesics.

Product Differentiation

DURAGESIC-50 distinguishes itself with reliable delivery over 72 hours, established clinical efficacy, and broad prescriber acceptance, although patent expiration and market saturation limit long-term exclusivity. The emergence of novel delivery systems and abuse-deterrent formulations also influence competitive positioning.

Financial Trajectory Analysis

Revenue Flow and Pricing Strategies

Historically, DURAGESIC-50 has commanded premium pricing based on its clinical utility and brand recognition. However, patent expiration in the late 2010s facilitated market entry of generics, resulting in significant price erosion. Current revenues depend heavily on regional market penetration, payer reimbursement policies, and prescriber preferences.

Impact of Patent Expiry and Generics

Patent expiration in many jurisdictions led to increased availability of generic fentanyl patches, which reduced sales of branded DURAGESIC-50 and compressed profit margins. According to industry reports, generic sales potentially surpass branded revenues, especially where price sensitivity is high.

Regulatory and Legal Factors

Heightened oversight due to opioid misuse concerns has led to stricter prescribing guidelines, potentially constraining volume growth. Conversely, efforts to combat pain in a regulated manner can sustain demand if properly managed within legal frameworks.

Market Penetration and Expansion Opportunities

Emerging markets offer growth prospects owing to expanding healthcare infrastructure and rising chronic pain prevalence. However, regulatory hurdles and local pricing negotiations remain challenges. Additionally, innovation in drug formulations, such as abuse-deterrent features, could command premium pricing, positively influencing financial trajectories.

Emerging Trends and Their Financial Implications

• Technological Innovations: Development of abuse-deterrent fentanyl patches and personalized dosing can preserve product relevancy and profitability.
• Policy and Reimbursement Shifts: Governments are revising guidelines to restrict high-potency opioids; reimbursement policies may favor alternative pain therapies, impacting sales.
• Market Consolidation: Mergers and acquisitions among generic manufacturers could affect pricing dynamics and market control.
• Digital Health Integration: Usage monitoring and telemedicine support for opioid prescriptions could influence prescribing patterns and sales volumes.

Regional Market Dynamics

• North America: Largest market driven by high chronic pain burden, advanced healthcare systems, but challenged by opioid restrictions.

• Europe: Stable growth with rigorous regulatory environments; substitution by generics influences revenues.

• Asia-Pacific: Promising expansion potential as healthcare infrastructure improves, with pricing and regulatory hurdles to address.

Risks and Opportunities

Risks:

• Stringent regulation limiting prescription volumes.
• Rising prevalence of abuse and diversion leading to tighter controls.
• Competition from non-opioid analgesic solutions.

Opportunities:

• Growing pipeline of abuse-deterrent formulations.
• Expanding into emerging markets with growing healthcare access.
• Strategic partnerships to enhance distribution.

Conclusion

The financial prospects of DURAGESIC-50 are shaped by a complex interplay of market forces, regulatory changes, technological advances, and regional dynamics. While the product faces challenges from patent expirations and tightening regulations, opportunities in emerging markets and innovations in drug delivery systems offer pathways to sustained revenue streams. Strategic focus on compliance, market expansion, and product differentiation remains essential for optimizing long-term financial outcomes.

---

Key Takeaways

• The global opioid analgesics market is expanding modestly, with transdermal formulations like DURAGESIC-50 playing a significant role.
• Patent expirations and the rise of generics have reduced branded sales, tightening profit margins.
• Regulatory pressures amid the opioid crisis pose a major risk, but innovations such as abuse-deterrent patches could sustain premium pricing.
• Emerging markets present potential growth avenues, contingent upon navigating local regulatory and pricing landscapes.
• Strategic diversification, technological innovation, and adherence to changing prescribing regulations are critical for maintaining and enhancing the product’s financial trajectory.

---

FAQs

1. How has DURAGESIC-50’s market share changed post-patent expiration?
The expiration of patents has led to increased generic competition, reducing market share and revenues for the branded DURAGESIC-50 product. However, continued prescriber loyalty and differentiating features like abuse-deterrent formulations help retain a segment of patients.

2. What regulatory trends are impacting DURAGESIC-50’s market?
Stringent prescribing guidelines due to the opioid epidemic, restrictions on high-dose opioid prescriptions, and enhanced monitoring requirements are limiting volume growth and influencing market access.

3. Are there any recent innovations that could boost DURAGESIC-50’s financial prospects?
Yes. Development of abuse-deterrent fentanyl patches and combination formulations targeting safer use are promising innovations that can command higher prices and expand market acceptance.

4. Which regions are most promising for DURAGESIC-50 expansion?
Emerging markets in Asia-Pacific and Latin America offer growth opportunities due to increasing healthcare infrastructure and chronic pain prevalence, although regulatory and pricing barriers must be addressed.

5. What is the outlook for DURAGESIC-50 amidst increasing competition from non-opioid pain therapies?
Long-term success requires differentiation through safety features, targeted marketing to appropriate patient populations, and integration into multimodal pain management strategies to remain relevant.

---

Sources:

[1] GlobalData. "Opioid Analgesics Market Analysis." 2022.