DURAGESIC-25 Drug Patent Profile

When do Duragesic-25 patents expire, and when can generic versions of Duragesic-25 launch?

Duragesic-25 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-25 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-25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,632
DailyMed Link:	DURAGESIC-25 at DailyMed

Recent Clinical Trials for DURAGESIC-25

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-25 clinical trials

US Patents and Regulatory Information for DURAGESIC-25

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-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990	4,060,084
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990	4,588,580*PED
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990	4,144,317

EU/EMA Drug Approvals for DURAGESIC-25

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-25

See the table below for patents covering DURAGESIC-25 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
Spain	8707667

Supplementary Protection Certificates for DURAGESIC-25

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
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

Market Dynamics and Financial Trajectory for DURAGESIC-25

Last updated: July 28, 2025

Introduction

DURAGESIC-25, a transdermal fentanyl patch, plays a pivotal role in managing chronic, severe pain, primarily among patients with cancer or those undergoing palliative care. Its unique delivery mechanism ensures sustained analgesia, reducing the need for frequent dosing. As a high-value, controlled substance, the market lifecycle and financial prospects for DURAGESIC-25 are intricately influenced by regulatory, competitive, and societal factors. This comprehensive analysis examines the current market landscape, revenue streams, regulatory environment, competitive positioning, and future growth potential of DURAGESIC-25, providing critical insights for stakeholders in the pharmaceutical sector.

Market Landscape and Demand Drivers

Epidemiological Factors

The global burden of chronic pain, especially among cancer patients, remains substantial. According to the Global Burden of Disease Study, an estimated 10-20% of adults worldwide experience persistent pain, with a significant proportion requiring potent opioids like fentanyl for management [1]. The increasing prevalence of cancer diagnoses further amplifies demand for long-acting analgesics such as DURAGESIC-25.

Acceptance in Pain Management

DURAGESIC-25 is preferred in scenarios requiring steady, long-term pain control. Its transdermal design ensures consistent plasma drug levels, minimizing peaks and troughs associated with oral opioids, thereby reducing side effects and improving patient compliance [2]. The drug's positioning in treatment protocols enhances its continued clinical relevance.

Market Penetration and Geographic Reach

Historically, DURAGESIC-25 has seen robust adoption in North America and Europe, driven by established healthcare infrastructure and regulatory acceptance. Emerging markets show promising growth potential due to increasing healthcare access and rising chronic pain prevalence, though regulatory hurdles and socio-cultural factors influence uptake.

Regulatory and Safety Considerations

Stringent Regulatory Oversight

Fentanyl's high potency and abuse potential entail tight regulatory controls globally. Agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others impose strict prescribing guidelines and monitoring programs impacting the distribution and sales of DURAGESIC-25 [3].

Risk Mitigation and Formulation Innovations

Ongoing efforts focus on risk mitigation, including tamper-resistant formulations and abuse-deterrent features, to address misuse concerns. These innovations may influence market acceptance and the financial trajectory by reducing regulatory restrictions and liabilities.

Competitive Landscape

Key Players and Alternatives

DURAGESIC-25 faces competition from other transdermal patches (e.g., Butrans) and alternative opioid formulations like extended-release oral opioids. Biosimilar and generic versions of fentanyl patches are entering markets, exerting downward pressure on pricing.

Market Differentiation

In a competitive setting, DURAGESIC-25's clinical efficacy, safety profile, and physician familiarity sustain its market position. However, emerging products emphasizing abuse deterrence and improved patient comfort threaten to displace older formulations.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Although comprehensive sales data specific to DURAGESIC-25 are proprietary, the broader fentanyl transdermal patch market has displayed steady growth, driven by increasing adult pain management needs. Estimated global sales of fentanyl patches hovered around USD 2 billion in recent years, with mature markets accounting for a sizable share [4].

Forecasted Growth and Risks

Projections suggest a compounded annual growth rate (CAGR) of approximately 4-6% over the next five years, contingent on regulatory stability, healthcare adoption, and societal attitudes toward opioid prescribing. However, the trajectory faces headwinds from rising opioid regulatory restrictions, societal opioid aversion, and the advent of non-opioid pain therapies.

Pricing and Reimbursement Dynamics

Pricing strategies for DURAGESIC-25 are affected by reimbursement policies, with insurance coverage varying across regions. Cost-containment initiatives and the proliferation of generics could compress margins but expand access, balancing out revenue streams.

Societal and Ethical Factors Influencing Market Dynamics

The opioid epidemic has led to increased scrutiny over long-acting opioids, prompting policy shifts favoring cautious prescribing. These measures may constrain market growth temporarily but also incentivize innovation in safer formulations, indirectly shaping DURAGESIC-25's commercial prospects.

Future Outlook and Investment Considerations

Emerging Trends

• Innovative Formulations: Development of abuse-deterrent patches could revitalize market interest.
• Digital Integration: Incorporation of smart technology for adherence monitoring.
• Regulatory Evolution: Adaptive policies may either hinder or facilitate market expansion.

Market Expansion Opportunities

• Underpenetrated Regions: Latin America, Asia-Pacific, and parts of Africa present potential growth avenues, contingent on regulatory frameworks and healthcare infrastructure development.
• Chronic Pain Management Shift: An aging global population fosters increased demand for sustained-release analgesics, supporting DURAGESIC-25’s long-term viability.

Key Challenges and Risks

• Regulatory crackdowns and societal opioid skepticism could restrict sales.
• Competition from non-opioid therapies may erode market share.
• Patent expirations and availability of generics threaten pricing power.

Conclusion

The financial and market outlook for DURAGESIC-25 remains cautiously optimistic, emphasizing the importance of navigating regulatory landscapes, fostering innovation, and expanding access in emerging markets. Stakeholders should monitor policy developments and technological advancements closely to adapt strategies, ensuring sustainable growth amid evolving societal attitudes and competitive pressures.

Key Takeaways

• Steady Demand Backed by Clinical Efficacy: DURAGESIC-25 continues to serve a critical role in managing severe, chronic pain, especially in oncology settings.
• Regulatory Environment Is Pivotal: Stringent controls and safety concerns necessitate ongoing innovation and risk mitigation.
• Market Competition Is Intensifying: Generic entrants and abuse-deterrent formulations are reshaping competitive dynamics.
• Emerging Markets Offer Growth Potential: Rapid healthcare expansion and aging populations in developing regions can drive future sales.
• Societal Attitudes Toward Opioids Will Remain a Double-Edged Sword: Balancing pain management needs with opioid misuse prevention is critical for long-term success.

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FAQs

1. How does DURAGESIC-25 compare to other opioid delivery methods in efficacy?
DURAGESIC-25 provides a sustained, consistent release of fentanyl, leading to stable plasma levels and superior pain control in chronic, severe pain cases compared to short-acting opioids. Its transdermal route improves adherence and reduces dosing frequency, making it preferable in long-term management.

2. What regulatory challenges could impact DURAGESIC-25’s market?
Strict prescribing guidelines, abuse-deterrent requirements, and monitoring programs influence distribution channels. Regulatory agencies increasingly scrutinize high-potency opioids, potentially limiting access or imposing additional usage restrictions.

3. Will generic versions of fentanyl patches erode DURAGESIC-25’s market share?
Yes. The expiration of patents and advent of biosimilars generally lead to price competition and decreased revenue margins, although brand loyalty and clinical preferences can sustain some premium positioning.

4. What innovations could extend the product lifecycle of DURAGESIC-25?
Formulations integrating abuse-deterrent features, digital adherence tools, and alternative delivery mechanisms could enhance safety and compliance, prolonging market relevance.

5. How does societal perception of opioids influence DURAGESIC-25’s future?
Heightened awareness of opioid misuse has led to more conservative prescribing practices. Conversely, increased focus on pain management rights may bolster demand within regulated frameworks, demanding strategic balancing.

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Sources

[1] Global Burden of Disease Study, 2019.
[2] Saulsberry, L., et al., "Transdermal fentanyl: clinical considerations," Journal of Pain Management, 2021.
[3] U.S. Food and Drug Administration (FDA) - Regulatory Guidance on Opioid Analgesics.
[4] MarketWatch, "Fentanyl Transdermal Patch Market Size and Forecast," 2022.