DURAGESIC-75 Drug Patent Profile

Which patents cover Duragesic-75, and what generic alternatives are available?

Duragesic-75 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-75 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-75

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,676
DailyMed Link:	DURAGESIC-75 at DailyMed

Recent Clinical Trials for DURAGESIC-75

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-75 clinical trials

US Patents and Regulatory Information for DURAGESIC-75

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-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-75

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990

EU/EMA Drug Approvals for DURAGESIC-75

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-75

See the table below for patents covering DURAGESIC-75 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-75

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 the Pharmaceutical Drug: DURAGESIC-75

Last updated: July 29, 2025

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Introduction

DURAGESIC-75 (fentanyl transdermal system) is a potent synthetic opioid analgesic indicated primarily for managing severe chronic pain where other treatments have proven inadequate. Given its potency, regulatory scrutiny, and evolving market landscape, understanding its market dynamics and financial trajectory is crucial for stakeholders including pharmaceutical companies, healthcare providers, and investors. This analysis employs a comprehensive review of current market factors, regulatory influences, competitive landscape, and future growth prospects to project DURAGESIC-75’s financial impact over the coming years.

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Market Overview and Demand Drivers

The global pain management market is experiencing sustained growth, driven by rising prevalence of chronic pain conditions, an aging population, and increased awareness of pain management options. The demand for potent opioids like fentanyl remains significant in this context, especially among patients with refractory pain, cancer-related suffering, and post-surgical recovery.

Key drivers include:

• Chronic Pain Prevalence: An estimated 1.5 billion people globally suffer from chronic pain, with a substantial proportion requiring opioid-based therapeutics (WHO). This size of the patient pool directly influences demand for DURAGESIC-75, which provides sustained analgesia for severe pain.

• Aging Population: Elderly populations are disproportionately affected by chronic pain, demonstrating increased utilization of patch-based opioid delivery systems due to ease of use and consistent dosing.

• Clinical Preference for Transdermal Delivery: The convenience and steady plasma levels associated with transdermal fentanyl formulations contribute to clinician preference, supporting continued demand.

• Regulatory and Reimbursement Environment: Reimbursement policies in developed markets favor established opioid formulations, further stabilizing DURAGESIC-75’s sales, although stricter opioid regulations could temper future growth.

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Regulatory Landscape and Market Challenges

Regulatory Scrutiny:
Fentanyl’s high potency has led to increased scrutiny over prescribing practices and misuse potential. Regulatory agencies such as the FDA have imposed stringent controls, including patient monitoring programs and prescribing restrictions (FDA 2022). The risk of abuse and addiction remains a significant concern, prompting risk mitigation strategies that can impact the drug’s market penetration.

Legal and Ethical Considerations:
The opioid epidemic has catalyzed lawsuits and regulatory actions worldwide, compelling manufacturers to implement tamper-resistant formulations and enhanced risk management protocols. These measures increase production costs and can influence pricing strategies.

Market Challenges:

• Opioid Substitution: Rising adoption of non-opioid analgesics and novel modalities, such as nerve blocks or non-steroidal anti-inflammatory drugs, could limit the growth of traditional opioids.
• Drug Abuse Deterrents: The introduction of abuse-deterrent formulations (ADFs) may shift prescribing favor towards newer, tamper-resistant options, potentially impacting DURAGESIC-75’s market share.
• Generic Competition: Once patent protections expire, generic fentanyl patches will flood the market, exerting downward pressure on prices and profit margins.

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Competitive Landscape

The fentanyl transdermal market features several key players, including Mylan, Teva, and Sandoz, alongside innovator products like DURAGESIC-75. The competitive dynamics depend on:

• Product Differentiation: DURAGESIC-75’s steady-release mechanism is a core competitive advantage, but newer formulations with abuse-deterrent features are emerging.
• Pricing Strategies: Manufacturers adopting aggressive pricing, especially post-patent expiry, challenge DURAGESIC-75’s premium positioning.
• Distribution and Prescriber Relationships: Strong relationships with healthcare providers and exclusive distribution contracts sustain market share.
• Regulatory Approvals and Labeling: Expanding indications or enhanced safety profile approvals can provide competitive edges.

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Financial Trajectory and Market Projections

Historical Performance:
While detailed revenue data for specific formulations like DURAGESIC-75 are proprietary, the broader fentanyl transdermal market has demonstrated steady growth. Global sales of fentanyl patches were valued at approximately USD 1.2 billion in 2020, with a compound annual growth rate (CAGR) of around 4% from 2015-2020 [1].

Projected Growth Trends:

• Short-term Outlook (1-3 years):

  • Continued steady demand in established markets as physicians prefer familiar modalities.
  • Regulatory tightening may temporarily constrain growth, especially in certain jurisdictions like the US and Europe.
  • Market stabilization due to patent protections and limited immediate competition.

• Mid to Long-term Outlook (3-10 years):

  • Patent expiry and entry of generics are expected to reduce prices by 40-60%, impacting revenue margins but expanding market volume.
  • Adoption of abuse-deterrent formulations could cannibalize DURAGESIC-75’s sales unless reformulation occurs.
  • Emerging markets with expanding healthcare infrastructure could offer new revenues, albeit at lower margins.

Revenue Estimates:
Assuming a conservative CAGR of 3-4% post-2023, driven by global market expansion and steady demand in chronic pain patients, revenues could plateau around USD 1.3–1.5 billion in 2028. The decline in unit pricing due to generic competition will compress margins, though volume growth across emerging markets may offset this loss.

Profitability Considerations:

• Pricing pressures will challenge profitability, especially in markets with intense generic competition.
• Cost of compliance with regulatory measures and investment in abuse-deterrent technologies will influence profit margins.
• Market share retention strategies, such as expanding indications or accruing convenient formulations, are crucial for sustaining financial performance.

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Future Opportunities and Risks

Opportunities:

• Developing next-generation abuse-deterrent formulations aligned with regulatory expectations.
• Expanding indications, such as postoperative pain or specific cancer-related pain, to widen market scope.
• Entering emerging markets with unmet pain management needs, leveraging local partnerships.

Risks:

• Regulatory constraints intensifying, reducing prescriptive flexibility.
• Public health policies reducing opioid prescribing, especially in jurisdictions ramping up opioid stewardship programs.
• Market shifts toward non-opioid therapies, including neuromodulation and cannabinoids.
• Patent cliffs accelerating entry of generics, reducing revenue, and market share.

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Key Takeaways

• Stable to modest growth in established markets supported by steady demand for severe chronic pain management using DURAGESIC-75.
• Regulatory and legal challenges necessitate investment in risk mitigation strategies, which may impact profitability and market access.
• Patent expiration and generic competition will significantly pressure prices, compelling innovation and differentiation strategies.
• Emerging markets present meaningful growth opportunities, particularly if regulatory barriers are navigated effectively.
• Innovation in abuse-deterrent technology and broader indication spectrum are crucial to maintaining competitive advantage.

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Conclusion

DURAGESIC-75’s market trajectory hinges on balancing demand for potent pain management solutions with evolving regulatory and competitive landscapes. While near-term prospects remain favorable in stable markets, long-term growth will require strategic innovation, regulatory compliance, and active engagement with emerging markets. Stakeholders should monitor regulatory policies, patent timelines, and technological advancements to optimize financial outcomes.

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FAQs

1. How does regulatory scrutiny impact DURAGESIC-75’s market potential?
Regulatory agencies impose prescribing restrictions, monitoring requirements, and safety measures for fentanyl products. Such scrutiny can limit prescription volumes and increase compliance costs, thereby affecting revenue growth.

2. What is the outlook for DURAGESIC-75 after patent expiry?
Post-patent expiration, generic competitors will enter the market, exerting downward pressure on prices. Revenue will decline unless the manufacturer develops next-generation formulations or expands into new indications and regions.

3. How significant is the role of abuse-deterrent formulations in the future of fentanyl patches?
Abuse-deterrent formulations are essential in addressing public health concerns and complying with regulatory expectations. These innovations may sustain market relevance amid increasing abuse mitigation requirements.

4. Which emerging markets hold the most promise for DURAGESIC-75 growth?
Countries in Asia, Latin America, and Southeast Asia are experiencing expanding healthcare infrastructure and growing demand for pain management, presenting significant growth opportunities amid lower market penetration.

5. What competitive strategies are vital for maintaining DURAGESIC-75’s market share?
Key strategies include investing in abuse-deterrent technology, expanding indications, forming strategic alliances, and engaging in targeted pricing and marketing to maintain prescriber loyalty and adapt to market shifts.

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Sources

[1] MarketWatch, “Global Fentanyl Patches Market Report 2020,” 2020.