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	4,060,084
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990	4,144,317
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990	4,588,580*PED

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

International Patents for DURAGESIC-75

See the table below for patents covering DURAGESIC-75 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	8514445
United Kingdom	2165148	TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR
Germany	3546830	Transdermales Abgabesystem zur Verabreichung von Fentanyl (Device for delivering fentanyl across the skin)
Belgium	905568
Japan	2547726

Supplementary Protection Certificates for DURAGESIC-75

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID

Market Dynamics and Financial Trajectory for DURAGESIC-75

Last updated: December 31, 2025

Executive Summary

DURAGESIC-75, a prescription transdermal patch delivering fentanyl, is a critical player in managing chronic pain, especially for patients with cancer or severe pain refractory to other therapies. This comprehensive analysis explores its market environment, regulatory landscape, competitive position, and financial outlook. The drug’s revenue trajectory hinges on factors like regulatory approvals, patent status, pricing, reimbursement policies, and competitive innovation. As demand for potent opioid analgesics persists amidst increased scrutiny over opioid misuse, DURAGESIC-75’s market growth faces both opportunities and significant challenges.

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What Are the Key Market Drivers for DURAGESIC-75?

Driver	Impact and Details
Chronic Pain Treatment Demand	Rising prevalence—approximately 18% of adults worldwide experience chronic pain — fuels demand for potent analgesics like fentanyl patches (Global Burden of Disease Study, 2019).
Cancer Pain Management	Fentanyl patches are preferred for breakthrough or refractory pain, representing a sizable eligible patient pool.
Aging Population	Globally, the proportion of elderly increases, leading to higher opioid utilization for age-related pain conditions.
Regulatory Acceptance	Tightened approvals in major markets (e.g., FDA, EMA) influence market confidence and access.
Generics and Competition	Patent expirations open doors for generic versions impacting pricing strategies and market share.
Opioid Prescription Policies	Policies aiming to balance effective pain management with abuse prevention directly affect prescribing patterns.

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How Does Regulatory and Patent Status Influence DURAGESIC-75’s Market?

Regulatory Environment

• The US FDA approved DURAGESIC (fentanyl transdermal system) in 1990, with subsequent approvals in Europe and other jurisdictions.
• Recent Trends: The FDA has imposed stringent REMS (Risk Evaluation and Mitigation Strategies) for opioids, including DURAGESIC, to prevent misuse while ensuring pain access (FDA, 2018).
• Impact: Increased oversight influences prescribing behavior, potentially constraining growth but also encouraging safer use.

Patent and Generic Landscape

Patent Status	Details and Timeline	Implication
Original patent (DURAGESIC)	Expired in US (2019), EU (2020)	Competitors can market generics, leading to price erosion.
Patent Extensions & Formulation Patents	Extended protections in certain markets	Delay generic entry, sustaining higher margins temporarily.

Implication for Revenue Projections

• Patent expirations have historically precipitated sharp declines in drug prices (e.g., fentanyl patch generics in 2020).
• Companies may leverage formulation innovations or new delivery methods to extend exclusivity.

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What Are the Major Competitive Factors Impacting DURAGESIC-75?

Competitive Landscape Table

Drug/Brand	Formulation	Strengths	Weaknesses	Market Share
DURAGESIC (fentanyl)	75 mcg/hr transdermal patch	Established brand, clinician familiarity	Patent expiry, abuse potential	Leading (variable by region)
GENERIC Fentanyl Patches	Various manufacturers	Lower price, increased accessibility	Brand recognition lower	Growing post-patent expiry
Other Opioids	Morphine, oxycodone, hydromorphone	Widely available, different profiles	Less potent, e.g., oral bioavailability issues	Significant competition

Factors Influencing Market Competition

• Pricing Strategies: Generics price 20–50% lower than brand (IQVIA, 2022).
• Prescription Trends: Shift towards multimodal pain management reduces reliance on opioids.
• Safety Profile: Non-opioid alternatives gaining favor due to abuse concerns.

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Financial Trajectory and Revenue Projections

Historical and Projected Revenue

Year	Estimated Revenue (USD Millions)	Comments
2018	~$200 million	Peak utilization before patent expiry
2020	~$120 million (post-generic entry)	Price erosion due to generics
2023	~$150 million	Moderate recovery driven by formulation innovation and expanded indications
2025 (projected)	~$180–200 million	Potential growth with expanding pain management protocols

Note: Data based on industry reports and market analyses from IQVIA and EvaluatePharma.

Factors Impacting Revenue Growth

• Market Penetration: Gains in emerging markets and hospital settings.
• Pricing Power: Limited with generic competition, but premium segments persist through therapy adherence and niche indications.
• Reimbursement Policies: Variable across regions; US Medicare policies increasingly scrutinize opioid reimbursements.

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What Are the Major Challenges and Risks?

Challenge/Risk	Details
Opioid Abuse and Regulatory Clampdown	Increased regulations limit prescribing volumes, especially in the US.
Patent Cliff	Loss of patent protection depresses price and volume.
Public Scrutiny and Litigation	Litigation risks pose reputational and financial threats.
Alternative Pain Therapies	Growing adoption of non-opioid modalities (neuromodulation, cannabis, etc.) reduces reliance.
Supply Chain Disruptions	Concentration of manufacturing hubs can lead to shortages or cost shocks.

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Comparison of DURAGESIC-75 with Major Alternatives

Parameter	DURAGESIC-75	Oral Opioids	Non-Opioid Alternatives
Route	Transdermal	Oral	Various (Neuromodulation, NSAIDs, etc.)
Onset of Action	12–24 hours	Minutes to hours	Variable
Duration	Up to 72 hours	Variable	Variable
Abuse Potential	High (due to potency)	Moderate to high	Low/None
Patient Convenience	High (once daily)	Multiple doses per day	Less convenient
Cost	Higher (brand and patent-dependent)	Lower	Varies

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Insights on Market Trends and Future Outlook

Innovations and New Formulations

• Efforts to develop abuse-deterrent formulations (ADFs) aim to extend product life cycles.
• Transdermal delivery innovation—such as patches with faster onset or reversible adhesion—is ongoing.

Emerging Markets

• Growth in Asia-Pacific, Latin America, with expanding healthcare infrastructure and pain management programs.
• Variability in regulatory landscape presents both opportunities and challenges.

Regulatory and Policy Forecasts

Future Policy/Trend	Potential Impact
Enhanced Opioid Prescription Monitoring	Curb overprescribing, limit market size growth
Adoption of Alternative Care Models	Decrease reliance on opioids, affecting sales
Stricter OTC and Reimbursement Controls	Impact access and insurance coverage

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Conclusion: Strategic Recommendations

1. Monitor Patent Expiry and Generic Entry: Prepare for revenue impact by innovating or expanding indications.
2. Invest in Abuse-Deterrent Technologies: Differentiate with safer formulations to navigate regulatory shifts.
3. Expand Market Reach: Leverage emerging markets and hospital channels.
4. Align with Policy Trends: Develop stewardship programs aligning with new regulations to assure prescriber and payer acceptance.
5. Diversify Portfolio: Invest in non-opioid pain management alternatives to buffer against declining opioid markets.

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Key Takeaways

• DURAGESIC-75 remains a significant component of severe pain management; however, its growth is increasingly constrained by patent expiration, generics, and regulatory pressures.
• The global aging population and prevalence of chronic pain support a baseline demand trajectory, particularly in developed markets.
• Competitive pressures demand continuous innovation, especially in abuse deterrence and formulation improvements.
• Market expansion in emerging economies offers potential upside, contingent upon favorable regulatory environments.
• Evolving prescribing policies and societal attitudes towards opioids necessitate strategic agility for sustained commercial success.

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FAQs

Q1: How does patent expiry affect DURAGESIC-75’s market share?
A: Once patents expire, generic versions enter the market, leading to substantial price declines and potentially eroding the brand’s market share unless differentiated by formulation or indications.

Q2: What regulatory measures are most impacting DURAGESIC-75?
A: The FDA's REMS program and stricter opioid prescribing guidelines aim to minimize misuse, which can both reduce supply and influence prescriber behavior.

Q3: Are there any promising innovations that could revitalise DURAGESIC-75’s market?
A: Yes. Abuse-deterrent formulations, faster-onset patches, and combination products offer potential avenues for revitalization.

Q4: How does the global trend towards opioid stewardship influence DURAGESIC-75?
A: Increasing emphasis on responsible prescribing may limit use, but also underscores the importance of safer formulations and targeted therapy.

Q5: What other therapies are competing with DURAGESIC-75?
A: Non-opioid analgesics, neuromodulation devices, and emerging biotech therapies aim to reduce reliance on opioids for pain management.

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References

1. Global Burden of Disease Study. "Global prevalence of chronic pain." 2019.
2. FDA. "Opioid Analgesic REMS," 2018.
3. IQVIA. "Prescription Drug Market Data," 2022.
4. EvaluatePharma. "Topline Analysis of Pain Management Drugs," 2022.
5. European Medicines Agency. "DURAGESIC Authorization," 2020.

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Disclaimer: This report is for informational purposes only and does not constitute investment advice.