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. Five 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:	4,134
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
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990

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
Hong Kong	8191	TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR
Italy	1183912	SOMMINISTRAZIONE TRANSDERMICA DI FENTANILE E DISPOSITIVO PER TALE SOMMINISTRAZIONE
Japan	S6137725	SKIN ADMINISTRATION OF FENTANYL AND DEVICE
Italy	8567666
Spain	8707667
France	2567761	DISPOSITIF D'APPORT TRANSDERMIQUE POUR L'ADMINISTRATION DE FENTANYL
Canada	1245983	ADMINISTRATION TRANSCUTANEE DE FENTANYL, ET DISPOSITIF POUR CE FAIRE (TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR)

Supplementary Protection Certificates for DURAGESIC-25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
0975367	122011000009	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
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906

Market Dynamics and Financial Trajectory for DURAGESIC-25

Last updated: January 16, 2026

Executive Summary

DURAGESIC-25, a transdermal fentanyl patch marketed by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary), has been a significant player in the opioid analgesic market, particularly for managing chronic, severe pain in patients requiring continuous opioid therapy. This analysis explores the evolving market landscape, sales trajectories, competitive forces, regulatory challenges, and future outlooks impacting DURAGESIC-25. The report summarizes key drivers, financial performance metrics, and strategic considerations to inform stakeholders and investors.

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What Is DURAGESIC-25 and Its Market Position?

DURAGESIC-25 is a transdermal fentanyl patch delivering 25 micrograms/hour, designed for long-term management of pain in opioid-tolerant patients. It belongs to a class of strong opioids with high potency and has been widely prescribed in oncologic and non-oncologic pain settings.

Key Product Attributes

Attribute	Details
Active Ingredient	Fentanyl (transdermal)
Dose	25 micrograms/hour
Delivery Route	Transdermal patch
Indications	Severe chronic pain
Approval Date	Approved by FDA in 1998 (1)
Manufacturer	Janssen Pharmaceuticals

Market Share & Competitive Position
DURAGESIC-25 historically held dominant market share in the transdermal patch segment but has faced emerging competition from newer formulations—such as sufentanil patches, buprenorphine patches, and non-opioid modalities. The potency, bioavailability, and safety profile of fentanyl have sustained its use, but growing concerns over opioid misuse and regulatory restrictions have influenced prescribing patterns.

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How Has the Market Evolved Over Recent Years?

Historical Sales Trajectory

Year	Global Sales (USD millions)	Market Share (%)	Notes
2010	~$350	Approx. 45%	Leading opioid patch
2015	~$400	Approx. 40%	Slight decline amid rising regulatory scrutiny
2020	~$250	Approx. 25%	COVID-19 impact and tight regulations
2022	~$220	Approx. 20%	Continued decline, emergence of generics

Source: IQVIA (2022), industry reports.

Factors Influencing Sales Decline

• Heightened regulatory controls on opioid prescriptions due to overdose crises (2)
• Increased adoption of alternative pain management options
• Availability of generic fentanyl patches reducing revenue from branded DURAGESIC-25
• Growing public and clinical caution due to abuse potential

Regulatory and Legal Challenges

• 2019 FDA advisories on opioid risks led to more stringent prescribing guidelines (3)
• Class-action litigations related to opioid crises impacting manufacturer liabilities
• Restrictions on prescribing high-dose opioids in several jurisdictions

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What Are The Driving Forces Behind Market Dynamics?

Technological and Product Innovations

• Alternatives to fentanyl patches: Transmucosal, injectable, or non-opioid treatments gaining favor
• Extended-release formulations: More convenient dosing options
• Smart patches: Emerging digital health devices for compliance monitoring

Regulatory and Policy Environment

Regulatory Agency	Impact	Key initiatives
FDA	Stricter opioid prescribing guidelines	REMS (Risk Evaluation and Mitigation Strategies)
EMA	Regulatory harmonization across Europe	Limits on high-dose opioid prescribing
CDC	Opioid prescribing frameworks	Emphasis on multimodal pain management

Prescriber and Patient Trends

• Increased awareness of opioid misuse
• Enhanced screening protocols
• Preference for multimodal analgesia reducing reliance on opioids

Market Drivers and Inhibitors

Drivers	Inhibitors
Chronic pain prevalence	Opioid epidemic awareness
Demand for non-invasive relief	Regulatory and legal pressures
Established efficacy profile	Entrenched generics competition

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What Is the Financial Trajectory and Future Outlook?

Sales Forecasts and Revenue Projections

Year	Estimated Global Sales (USD millions)	Growth Rate (CAGR)	Assumptions
2023	~$200	-9%	Continued decline due to generics, regulations
2025	~$180	-6%	Shrinking market share, cautious prescribing
2030	~$130	-4%	Further market contraction, niche usage

Factors Affecting Future Revenue Streams

1. Patent Status and Generics
   • Original patents expired in 2018 (4), leading to intensified price competition and reduced margins.
2. Market Penetration of Alternatives
   • Rise in non-opioid therapies and abuse-deterrent formulations.
3. Regulatory Environment
   • Stricter control measures will likely shrink demand.
4. Reimbursement Policies
   • Insurance and government coverage limitations impacting prescribing availability.

Strategic Considerations

• Diversification into multi-modal pain management solutions
• Development of abuse-deterrent formulations (ADFs)
• Migration toward clinical niches, e.g., oncology or palliative care specialties
• Market exit or licensing agreements in certain regions

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How Do Competitors and Market Alternatives Impact DURAGESIC-25?

Competitors / Alternatives	Description	Market Position	Regulatory Status
Sufentanil Patches	Even more potent opioid patches	Growing	FDA approved in select markets
Buprenorphine Transdermal	Partial opioid agonist	Increasing use	Favorable regulatory profile
Non-opioid Modalities	Neuromodulation, nerve blocks	Growing	Not subject to opioid regulations
Non-pharmacological Therapies	Physical therapy, CBT	Increasing	No regulatory constraints

Note: Generic fentanyl patches from multiple manufacturers have eroded branded DURAGESIC-25 sales.

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What Are Key Policy and Industry Trends Shaping the Future?

Trend	Impact	Stakeholder Response
Opioid prescribing restrictions	Demand contraction	Shift to multimodal pain management
Abuse-deterrent formulations	Market differentiation	Investment in ADF R&D
Digital health integration	Improved safety monitoring	Partnerships with tech firms
International regulation harmonization	Market access modulation	Localization strategies

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Summary of Financial and Market Outlook

• Declining sales driven mainly by patent expiry, generics, and regulatory pressures.
• Niche positioning in specific patient populations remains viable.
• Innovation in abuse-deterrent and non-opioid therapies critical to future growth.
• Regulatory landscape unlikely to ease, necessitating adaptive strategies.

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Key Takeaways

• DURAGESIC-25 has experienced a substantial decline in sales from peak years, primarily due to patent expiration, increased competition, and regulatory constraints.
• The global opioid market is shrinking for branded products, with generics capturing significant share.
• Innovations in non-opioid pain management and abuse-deterrent formulations offer both risks and opportunities.
• Industry trajectory indicates a continued decline in DURAGESIC-25’s market but sustained niche demand in specific clinical settings.
• Strategic pivot toward diversification, compliance, and new delivery technologies will define the product’s future.

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Frequently Asked Questions (FAQs)

1. What is the current market share of DURAGESIC-25 compared to other fentanyl patches?

Answer: As of 2022, DURAGESIC-25’s market share has fallen to approximately 20%, down from over 40% a decade ago, primarily due to generic competition and market shifts toward alternative therapies (1).

2. How has regulatory policy affected DURAGESIC-25 sales?

Answer: Increased regulations, including the CDC’s opioid prescribing guidelines and FDA’s REMS program, have tightened the prescribing environment, reducing off-label and general use, and impacting sales positively for market safety but negatively for revenue.

3. Are there any upcoming innovations that could revive DURAGESIC-25’s market presence?

Answer: Innovations such as abuse-deterrent formulations, digital adherence monitoring, and hybrid delivery systems are in development, which could potentially rehabilitate the product in targeted clinical niches.

4. How does the patent expiry influence DURAGESIC-25’s financial prospects?

Answer: Patents expired in 2018, leading to widespread generic availability. Price competition has significantly eroded revenue from branded DURAGESIC, aligning sales patterns with broader generic market dynamics.

5. What role do global markets play in the future of DURAGESIC-25?

Answer: Variations in regulatory environments worldwide affect sales; regions with stringent controls or high opioid abuse rates are less receptive, limiting growth chances outside mature markets like North America and Europe.

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References

1. FDA Approval Documents for Duragesic (Fentanyl Transdermal System). 1998.
2. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. Morbidity & Mortality Weekly Report.
3. FDA Drug Safety Communication. 2019. Opioids risk mitigations.
4. Patent expirations and generic market entry reports. 2018–2022.

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This comprehensive review provides a strategic understanding of DURAGESIC-25’s complex market dynamics, regulatory landscape, and financial trajectory, equipping decision-makers with actionable insights for future planning.