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. Eight 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:	4,668
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
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-12

See the table below for patents covering DURAGESIC-12 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	545366
Spain	8707667
Italy	8567666
Germany	3546869	Transdermales Abgabesystem zur Verabreichung von Fentanyl
Japan	S6137725	SKIN ADMINISTRATION OF FENTANYL AND DEVICE
Germany	3526339

Supplementary Protection Certificates for DURAGESIC-12

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
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-12

Last updated: July 28, 2025

Introduction

DURAGESIC-12, a transdermal fentanyl patch, occupies a pivotal position within the opioid analgesic market, primarily targeting chronic, severe pain management such as cancer-related pain. Its market dynamics are shaped by evolving regulatory environments, demographic shifts, healthcare provider perceptions, and competitive landscape, all influencing its financial trajectory. This report analyzes key factors affecting DURAGESIC-12’s market performance and outlines strategic considerations for stakeholders.

Product Overview and Therapeutic Positioning

DURAGESIC-12 delivers sustained-dose fentanyl through skin absorption over a 72-hour period, offering consistent analgesic effects. Its formulation supports outpatient pain management, especially for opioid-tolerant patients. The drug’s market niche is distinguished by its high potency and unique delivery mechanism, making it a preferred choice for specific patient cohorts.

Market Dynamics Influencing DURAGESIC-12

Regulatory Environment and Opioid Policy Shifts

Regulatory scrutiny surrounding opioids profoundly impacts DURAGESIC-12’s market. The global opioid crisis has prompted stricter prescribing guidelines, particularly in the United States and Europe. Agencies like the FDA and EMA enforce risk mitigation strategies, including restricted prescribing and mandatory risk management programs, which limit rapid market expansion but aim to reduce misuse. This regulatory rigor constrains growth potential but heightens safety standards, influencing market acceptance.

Demographic Trends and Chronic Pain Prevalence

An aging population worldwide escalates the demand for potent, long-acting analgesics like DURAGESIC-12. Chronic pain conditions predominantly affect the elderly, with increasing incidences of cancer and degenerative diseases fueling prescription rates. According to the WHO, the prevalence of chronic pain affects up to 20% of adults globally, underpinning sustained demand for opioid patches.

Healthcare Provider Perception and Prescribing Patterns

Physicians balance effective pain relief against the risks of opioid misuse. A shift towards multimodal pain management, emphasizing non-opioid alternatives, moderates prescription volume. However, for appropriately selected patients, transdermal fentanyl remains a mainstay, stabilizing its demand. Provider education and fear of regulatory repercussions continue to influence prescribing behaviors, limiting the drug’s outreach but also reducing adverse event liabilities.

Market Competition and Alternative Therapies

DURAGESIC-12 faces competition from other opioid formulations, such as buprenorphine patches and oral opioids, as well as non-opioid analgesics and nerve blocks. Innovative delivery systems and abuse-deterrent formulations have emerged, challenging its market dominance. Biotech advancements and formulary preferences also shape competitive positioning.

Manufacturing and Supply Chain Factors

Supply chain stability impacts availability and pricing. Manufacturing complexities related to fentanyl synthesis and transdermal delivery impose barriers to scaling. Regulatory compliance costs and patent protections influence pricing strategies and profit margins.

Financial Trajectory and Market Forecast

Historical Financial Performance

DURAGESIC-12 has shown consistent revenue streams in specific markets, notably North America and Europe, driven by its established clinical profile and hospital protocols. However, recent trends indicate a plateauing or modest decline attributable to regulatory pressures and market saturation.

Forecasted Growth and Constraints

The global market for fentanyl patches was valued at approximately USD 4 billion in 2022, with a projected compound annual growth rate (CAGR) of around 2-3% through 2030 (source: [1]). DURAGESIC-12's segment is expected to mirror this trajectory, with regional variations:

• United States: Growth constrained by opioid prescribing reforms; however, demand persists in well-established pain management protocols.
• Europe: Market expansion limited by stringent regulatory frameworks but supported by aging demographics.
• Emerging Markets: Potential for significant growth due to increasing healthcare infrastructure but hampered by regulatory and reimbursement hurdles.

Pricing Dynamics

Pricing strategies are under scrutiny, balancing profitability and regulatory compliance. Value-based pricing models are gaining traction, with insurers demanding evidence of cost-effectiveness, especially as generic versions enter markets.

Impact of Generic Competition

Patent expirations and regulatory approvals of generics decrease prices and compress margins. Nonetheless, brand loyalty and formulations with abuse-deterrent features may sustain premium positioning.

Strategic Considerations for Stakeholders

• Regulatory Engagement: Active collaboration with authorities to comply with evolving standards and participate in risk management programs.
• Innovation: Investment in abuse-deterrent formulations and transdermal technology enhancements to differentiate offerings.
• Market Expansion: Leveraging emerging markets with focus on infrastructure development and education.
• Diversification: Incorporating non-opioid analgesics within portfolios to mitigate regulatory risks and diversify revenue streams.
• Pricing Strategies: Emphasizing value-based models aligned with clinical outcomes to sustain profitability amid market pressures.

Conclusion

DURAGESIC-12’s market outlook is characterized by steady demand in its established niches, tempered by regulatory challenges and increasing competition. Its financial trajectory is projected to grow modestly, influenced by demographic trends, technological innovation, and policy developments. Stakeholders must navigate these dynamics strategically, balancing market opportunities against risks inherent to opioid therapeutics.

Key Takeaways

• The aging global population sustains demand for long-acting opioid patches like DURAGESIC-12.
• Regulatory pressures significantly restrict prescribing practices, impacting growth prospects.
• Competition from generics and alternative therapies compresss margins, necessitating differentiation.
• Innovation in abuse-deterrent formulations and delivery mechanisms offers strategic advantage.
• Emerging markets present opportunities, provided regulatory and infrastructure barriers are addressed.

FAQs

1. How do regulatory changes impact DURAGESIC-12’s sales?
Regulatory reforms aimed at controlling opioid misuse restrict prescribing, leading to decreased sales volume. However, stringent safety protocols can also enhance product credibility, maintaining niche markets.

2. What role does demographic aging play in the product’s market?
An aging population increases the prevalence of chronic pain conditions, expanding the patient base eligible for DURAGESIC-12, thus supporting sustained demand.

3. How does market competition affect DURAGESIC-12’s profitability?
Generic erosion and competing opioid formulations put downward pressure on prices and profit margins, necessitating innovation and strategic positioning.

4. Are emerging markets likely to become significant revenue sources?
Yes, as healthcare systems develop and access improves, these regions may offer growth potential, contingent upon overcoming regulatory and reimbursement challenges.

5. What strategic moves can enhance DURAGESIC-12’s market position?
Investing in abuse-deterrent technology, engaging with regulators proactively, expanding in emerging markets, and diversifying product portfolios will strengthen its market stance.

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References

[1] MarketResearch.com, "Global Opioid Patch Market 2022-2030," 2022.