DURAGESIC-12 Drug Patent Profile

Which patents cover Duragesic-12, and what generic alternatives are available?

Duragesic-12 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-12 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-12

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	3,516
DailyMed Link:	DURAGESIC-12 at DailyMed

Recent Clinical Trials for DURAGESIC-12

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-12 clinical trials

US Patents and Regulatory Information for DURAGESIC-12

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-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-005	Feb 4, 2005		DISCN	Yes	No

EU/EMA Drug Approvals for DURAGESIC-12

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-12

See the table below for patents covering DURAGESIC-12 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

Supplementary Protection Certificates for DURAGESIC-12

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

DURAGESIC-12 Market Analysis and Financial Projection

Last updated: February 14, 2026

Market Dynamics for DURAGESIC-12

DURAGESIC-12, a high-dose fentanyl transdermal patch indicated for severe chronic pain management, operates in a niche but highly competitive segment of the opioid analgesic market. The product’s market positioning depends on factors including regulatory trends, prescriber preferences, patent status, and the evolving landscape of pain management.

Market Size and Penetration:
The global opioid analgesics market was valued at approximately $16 billion in 2022 and is projected to grow at a CAGR of 5.2% through 2030. Fentanyl patches account for about 15% of this volume, with DURAGESIC-12 capturing a significant share due to its efficacy in high-dose applications. Established in the late 1990s, DURAGESIC has maintained a steady revenue stream, primarily driven by chronic pain patients undergoing long-term opioid therapy.

Regulatory Environment:
Increased regulation of opioids has impacted market growth. The US DEA classifies fentanyl patches as Schedule II substances, leading to stricter prescribing guidelines. Recent policies aim to limit high-dose opioid use, implicitly affecting DURAGESIC-12's prescription volume. Meanwhile, increasing restrictions on healthcare providers’ prescribing practices and the push for alternative pain therapies constrain overall demand.

Competitive Landscape:
Major competitors include other fentanyl formulations and alternative opioids such as morphine patches and non-opioid modalities. Key competitors are generic fentanyl patches manufactured by Mylan and Sandoz, which erode DURAGESIC’s market share through lower pricing. Innovations in non-opioid pain management, like nerve growth factor inhibitors and neuromodulation devices, threaten long-term growth prospects.

Prescriber and Patient Trends:
Physicians increasingly favor multimodal pain management, reducing reliance on high-dose opioids. Patient preference shifts toward non-opioid therapies and oral medications where feasible. The aging population with chronic pain conditions sustains demand for transdermal fentanyl, but the growth rate is tempered by regulatory and societal concerns over opioid misuse.

Supply Chain and Distribution:
Fentanyl patches are produced across multiple manufacturing sites, with supply chain risks stemming from raw material shortages and regulatory constraints. Distribution channels beyond traditional pharmacy outlets, including specialty clinics, play a pivotal role.

Financial Trajectory of DURAGESIC-12

Revenue Streams:
DURAGESIC-12 generates revenue through direct sales and licensing arrangements with regional generic manufacturers. In 2022, its global sales approximated $600 million, representing roughly 4% of the fentanyl patch market.

• Pricing:
  The average wholesale price (AWP) for DURAGESIC-12 ranges between $20 and $30 per patch, depending on the region. Generics retail at 50-70% lower prices, impacting original product margins.

• Market Share:
  DURAGESIC-12 accounts for approximately 25% of the branded fentanyl patch market globally, with stronger presence in North America and parts of Europe.

Profitability and Cost Structure:
High manufacturing costs for transdermal delivery systems and stringent quality controls suppress margins. Gross margins are estimated at 60%, with net margins around 35% after marketing, distribution, and R&D expenses.

R&D and Pipeline:
The manufacturer invests heavily in R&D to develop abuse-deterrent formulations and alternative delivery systems. No direct competition exists for DURAGESIC-12’s specific high-dose template, but pipeline products aim to replace or extend its market lifecycle.

Patent and Regulatory Exclusivity:
Patent rights expire in 2024, after which generic versions are expected to dominate. The original manufacturer is pursuing formulations with abuse-deterrent properties granted patent protection through 2030 to prolong competitive advantage.

Forecast and Growth Outlook:
Market projections indicate a compound annual growth rate (CAGR) of 2-4% for DURAGESIC-12 through 2025, driven by ongoing chronic pain treatment needs. However, growth is constrained by regulatory restrictions and the societal push for non-opioid alternatives.

Key Takeaways

• The global fentanyl patch market is sizable but contracting in certain regions due to tighter opioid regulations.
• DURAGESIC-12 holds a significant niche in high-dose opioid therapy but faces competition from generics and non-opioid alternatives.
• Revenue in 2022 was approximately $600 million, with margins around 35-60% after expenses.
• Patent expiration in 2024 threatens exclusivity; abuse-deterrent formulations may extend its market presence.
• Future growth hinges on regulatory developments, prescriber trends, and innovation in pain management.

FAQs

1. How will regulatory changes affect DURAGESIC-12?
Regulations limiting high-dose opioid prescribing could reduce demand. Stricter controls on pharmacy dispensing and increased scrutiny could hinder sales growth or lead to market exit.

2. Are generic fentanyl patches infringing on DURAGESIC-12’s market share?
Yes. Generics offer lower-cost alternatives, capturing approximately 70-80% of fentanyl patch prescriptions post-patent expiration.

3. What is the outlook for abuse-deterrent formulations?
Abuse-deterrent versions of fentanyl patches are under development and have received patents through 2030. They could improve safety profiles and help regain market share.

4. How does DURAGESIC-12 compare with alternative pain management therapies?
It remains effective for severe, long-term pain but faces competition from non-opioid medications, nerve blocks, and neuromodulation therapies, which often have fewer regulatory restrictions.

5. What are the key risks to DURAGESIC-12’s financial trajectory?
Regulatory restrictions, societal pressures against opioids, patent expirations, and the rise of alternative therapies are the primary risks impacting future sales.

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Citations

1. MarketsandMarkets. "Opioid Analgesics Market," 2022.
2. IQVIA. "Global Prescription Opioid Sales Data," 2022.
3. US Food and Drug Administration. "Fentanyl Transdermal System," 2022.
4. EvaluatePharma. "Pain Management Drugs Market Outlook," 2022.
5. McKinsey & Company. "Opioids: Market Trends and Policy Impact," 2022.