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. Five 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:	3,329
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	4,144,317

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
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

Supplementary Protection Certificates for DURAGESIC-50

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

Market Dynamics and Financial Trajectory for DURAGESIC-50

Last updated: January 15, 2026

Summary

DURAGESIC-50, a branded transdermal fentanyl patch, remains a significant player within the opioid analgesic market, especially for managing chronic cancer-related pain. Over the past decade, the product's market performance has been influenced by evolving regulatory landscapes, societal concerns over opioid misuse, and advancements in pain management alternatives. This report analyzes DURAGESIC-50’s current market position, growth prospects, competitive environment, and underlying financial trajectory to inform strategic decision-making for stakeholders.

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What is DURAGESIC-50 and How Does It Function in the Market?

DURAGESIC-50 is a transdermal patch delivering 50 micrograms per hour of fentanyl, a potent synthetic opioid. It is indicated primarily for:

• Patients with chronic pain requiring long-term opioid therapy
• Cancer pain management

Key specifications:

Attribute	Details
Dosage	50 micrograms/hour
Administration	Topical transdermal patch
Onset of Action	Usually within 12-24 hours
Duration	Up to 72 hours per patch

Market positioning: It provides continuous analgesia, benefits from patient compliance, and offers a predictable pharmacokinetic profile.

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Market Dynamics

1. Regulatory and Policy Impact

Opioid crisis and regulatory tightening have significantly influenced the pain management landscape:

• United States: The CDC’s 2016 opioid prescribing guidelines and subsequent DEA regulations restricted prescribing practices, affecting DURAGESIC-50 sales (Reference [1]).
• Europe and Asia: Different frameworks affect market access, with some countries imposing strict monitoring programs or limiting opioid prescriptions.

Impact on market:

Regulatory Measure	Effect on DURAGESIC-50 Market	Date/Source
Prescription monitoring	Decrease in prescriptions	CDC guidelines, 2016
Rescheduling to controlled substances	Restricted prescribing	DEA Schedule II (US), 2018
Reimbursement policies	Variable reimbursement rates	National health policies

2. Societal and Healthcare Trends

• Opioid misuse and abuse lead to heightened scrutiny of opioid patterns of use.
• Shift toward multimodal pain management reduces reliance on opioids.
• Rise of abuse-deterrent formulations (ADFs) impacts market share of traditional patches like DURAGESIC-50.

3. Competitive Landscape

Key competitors include:

Company	Product Name	Formulation/Strengths	Regulatory Status
Mylan (now part of Viatris)	Fentanyl Transdermal System	Generic fentanyl patches, lower-cost	FDA-approved generic, 2010
Teva	Fentanyl Patch	Competitive pricing	Approved, market share growth
Innovator (Johnson & Johnson)	DURAGESIC 50	Brand recognition, established safety profile	Market leader, patent expiry in US (2024)

Patent expiring expected in mid-2024 in the US, opening pathways for generics.

4. Market Size and Revenue Trends

Global opioid analgesic market estimated at $9.7 billion in 2022 with a projected CAGR of 3.8% from 2023 to 2030 (Source [2]).

DURAGESIC-50 specifics:

• Historical sales (2020-2022):

Year	Estimated Global Sales (USD millions)	Influencing Factors
2020	$180	Pandemic-related delays, regulatory constraints
2021	$200	Slight easing, increased focus on pain management
2022	$220	Market recovery, new regulatory pressures

• Projected trajectory: Post-patent expiry, generic competition is expected to reduce the variant's revenue by approximately 40-60% over 3-5 years, depending on regional patent litigations and reimbursement dynamics (Reference [3]).

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Financial Trajectory Analysis

1. Revenue Dynamics

Revenue Component	2023 Estimate	2024-2025 Projection	Key Variables
Brand sales (DURAGESIC-50)	~$200 million	Decline of 25-40%	Patent expiry, generic market entry
Generic competition	N/A	Rapid growth	Entry of generics reducing branded sales
Reimbursement & pricing	Stable to slightly declining	Increased price pressure	Payer negotiations, formulary restrictions

2. Cost Structure

Cost element	Approximate % of gross margin	Notes
Manufacturing & formulation	15-20%	Economies of scale, supply chain efficiencies
Marketing & sales	10-15%	Shifting promotional strategies
Regulatory compliance	5-10%	Investment, monitoring, legal costs
R&D	5-8%	Limited, post-patent expiration focus

3. Profitability Outlook

Scenario	2023-2025 Revenue Estimate	Gross Margin	EBITDA Margin	Projected Net Profit Decline
Optimistic (early generic uptake, price controls manageable)	$150-180 million	60%	35-40%	20-30% decline from 2022
Pessimistic (rapid generic commoditization, regulatory constraints)	<$100 million	50%	25-30%	>50% decline from 2022

Note: These estimates assume the patent expiry occurs as scheduled in 2024, with varying generic market penetration rates.

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Comparative Analysis: How Does DURAGESIC-50 Differ from Alternatives?

Aspect	DURAGESIC-50	Oral Opioids	Non-Opioid Alternatives	Abuse-deterrent Formulations
Delivery	Transdermal	Oral	Topical, injections	Transdermal, nasal sprays
Onset/Duration	12-24 hrs / up to 72 hrs	Variable	Variable	Designed to resist tampering
Risks	Skin irritation, overdose	GI side effects, overdose	Less effective for certain pain	Same as original formulations
Regulatory Oversight	High (due to abuse potential)	High	Variable	High (approval hurdles)

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Future Outlook and Growth Opportunities

1. Market Expansion

• Emerging markets such as China, India, and Brazil present growth potential owing to increased access to pain management therapies.
• Hospice and palliative care settings remain primary markets due to the complex management of severe pain.

2. Product Innovation and Portfolio Diversification

• Development of abuse-deterrent patches combining fentanyl with tamper-resistant features.
• Combination formulations with non-opioid agents to mitigate dependency issues.
• Transition toward personalized pain management solutions integrating pharmacogenomics.

3. Regulatory and Legal Developments

• Anticipated updates to opioid prescribing policies may influence prescribing volumes.
• Potential for new indications or formulations to sustain revenue growth after patent loss.

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Comparison Table: DURAGESIC-50 vs. Industry Benchmarks

Feature	DURAGESIC-50 (Current)	Industry Average (Opioid Patches)	Notes
Market Share (Global)	~10%	N/A	Dominant in branded patches
Average Revenue per Year	~$200 million	$150-300 million per key brand	Depending on regional sales
Patent Expiry Impact	Expected 2024	Similar for branded opioids	Industry-wide trend

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Key Takeaways

• Regulatory headwinds and societal concerns are constraining DURAGESIC-50’s growth, necessitating diversification and innovation.
• Patent expiration in 2024 will likely induce significant revenue erosion unless countered by generic market entry and product differentiation.
• Global market opportunities, especially in emerging economies and palliative care segments, can offset declining US and European revenues.
• Emerging abuse-deterrent technologies offer a future pathway to sustain market relevance amid heightened restrictions.
• Strategic planning must focus on lifecycle management, including potential re-formulations, pipeline expansion, and portfolio diversification.

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FAQs

Q1: What are the main factors influencing DURAGESIC-50’s market decline post-patent expiry?
A1: Patent expiry allows generic manufacturers to enter, increasing price competition and reducing branded sales. Regulatory shifts and societal concerns over opioid misuse further pressure sales.

Q2: How does DURAGESIC-50 compare to oral opioids in terms of safety and efficacy?
A2: As a transdermal patch, DURAGESIC-50 offers steady drug delivery with improved adherence, but carries risks such as skin irritation and overdose, similar to oral opioids but with differing pharmacokinetics.

Q3: Are there any developments in abuse-deterrent formulations for fentanyl patches?
A3: Yes, several companies are working on tamper-resistant patches and formulations that resist crushing or heating, aiming to reduce misuse potential.

Q4: What are emerging markets' prospects for DURAGESIC-50?
A4: These markets show increasing demand for effective pain relief; regulatory hurdles vary but generally represent a growth opportunity, especially in palliative care for cancer patients.

Q5: What strategies should stakeholders adopt to mitigate revenue loss after patent expiration?
A5: Innovate with new formulations, target emerging markets, diversify the product portfolio, and explore alternative pain management therapies to sustain revenue streams.

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References

[1] CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recommendations and Reports. 2016.

[2] Grand View Research. Opioid Analgesic Market Size & Trends, 2023-2030.

[3] IQVIA Data Reports, 2022. Pharmaceutical Market Trends.

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