DURAGESIC-100 Drug Patent Profile

Which patents cover Duragesic-100, and what generic alternatives are available?

Duragesic-100 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-100 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-100

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,674
DailyMed Link:	DURAGESIC-100 at DailyMed

Recent Clinical Trials for DURAGESIC-100

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-100 clinical trials

US Patents and Regulatory Information for DURAGESIC-100

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-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990

EU/EMA Drug Approvals for DURAGESIC-100

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

International Patents for DURAGESIC-100

See the table below for patents covering DURAGESIC-100 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

Supplementary Protection Certificates for DURAGESIC-100

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DURAGESIC-100

Last updated: July 29, 2025

Introduction

DURAGESIC-100, a transdermal fentanyl patch manufactured by Janssen Pharmaceuticals, is a potent opioid analgesic primarily indicated for managing severe pain in patients requiring around-the-clock treatment. With the global opioid market undergoing rapid shifts driven by regulatory, societal, and technological factors, understanding the comprehensive market dynamics and financial trajectory of DURAGESIC-100 is essential for investors, healthcare providers, and policymakers. This analysis examines current market drivers, competitive landscape, regulatory challenges, financial performance, and future outlook.

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Market Overview and Industry Landscape

The global opioid analgesics market was valued at approximately USD 15.6 billion in 2022 and is projected to reach USD 21.4 billion by 2028, growing at a CAGR of roughly 5.3% [1]. DURAGESIC-100, accounting for a significant share within the high-potency opioid segment, is positioned as a cornerstone for chronic pain management. Its transdermal delivery system offers advantages such as sustained pain relief, improved compliance, and reduced gastrointestinal side effects, which distinguishes it from oral opioids.

However, the increasing scrutiny over opioid addiction and misuse has prompted authorities worldwide to tighten prescribing guidelines, impacting market growth. The opioid epidemic, especially prominent in North America, has led to stricter regulations, reimbursement challenges, and a surge in alternative pain management therapies.

Market Drivers

1. Rising Prevalence of Chronic Pain Conditions

Chronic pain affects an estimated 20% of adults globally, with a significant portion requiring opioid therapy [2]. Aging populations in countries like the US, Europe, and Japan further elevate demand for potent analgesics such as DURAGESIC-100.

2. Advantages of Transdermal Delivery

DURAGESIC-100's transdermal patch ensures steady plasma fentanyl levels, promoting consistent pain control. Its ease of application enhances patient compliance, especially among those with swallowing difficulties or gastrointestinal issues.

3. Prescribing Trends for Severe Pain

Hospitals and pain clinics favor transdermal fentanyl patches in post-operative and cancer pain management. The convenience and efficacy contribute to sustained demand within hospital settings.

Market Challenges

1. Regulatory and Legal Constraints

Stringent regulations governing opioid distribution pose a formidable barrier. In the U.S., the DEA has further restricted prescription quantities and monitoring, limiting market expansion [3].

2. Public Health Concerns and Reimbursement

The opioid crisis has prompted health authorities to implement strict prescribing guidelines and risk mitigation strategies. Many insurers impose prior authorizations or limit prescriptions for fentanyl patches, impeding market growth.

3. Competition and Generic Entry

Generic fentanyl patches have entered the market, exerting price pressure on branded products like DURAGESIC-100. Despite patent protections expiring in some regions, Janssen continues to defend its market share through branding and safety features.

Financial Trajectory

1. Revenue Trends

Historical data indicates that while DURAGESIC-100 has maintained a steady revenue stream over the last decade, growth has plateaued post-2019, attributed to increasing regulatory restrictions and market saturation. In 2022, the product's global revenue was estimated at USD 250 million, representing a modest decline from previous peaks [4].

2. Cost Structures and Pricing

Janssen's pricing strategy has positioned DURAGESIC-100 as a premium product, with wholesale prices approximately USD 20-25 per patch, depending on dosage and region. Manufacturing costs are relatively stable due to established transdermal technology, but pricing pressures from generic competition threaten margins.

3. Investment and R&D

Ongoing R&D efforts aim to develop improved formulations with enhanced safety profiles, including abuse-deterrent features and alternative delivery mechanisms. These innovations could boost future revenue streams and market positioning.

Regulatory Outlook and Impact

Regulatory agencies, notably FDA in the U.S. and EMA in Europe, continue to implement policies to curb opioid misuse without compromising access for legitimate pain management. Recent FDA guidance emphasizes risk mitigation and mandates for abuse-deterrent formulations, which could entail reformulation costs for DURAGESIC-100 or influence its market share.

Potential reclassification or tighter restrictions threaten to reduce prescribing rates further, thereby impacting revenues. Conversely, approved abuse-deterrent formulations and integration into multimodal pain management strategies may mitigate some negative effects.

Competitive Landscape

DURAGESIC-100 faces direct competition from other transdermal fentanyl patches (e.g., Mylan, Teva) and non-opioid therapies like nerve blocks and nonsteroidal anti-inflammatory drugs (NSAIDs). The emergence of alternative modalities, including neuromodulation and medical cannabis, could further erode market share over time.

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Future Outlook and Market Trajectory

The outlook for DURAGESIC-100 hinges on navigating regulatory constraints, evolving prescriber behaviors, and societal attitudes toward opioids. The resurgence of interest in abuse-deterrent technologies and innovative delivery systems may offer growth avenues. Additionally, expanding into emerging markets with increasing chronic disease burdens could bolster revenues.

Technological advancements such as smart patches with dose monitoring and integrated safety features are anticipated to become differentiators. Nonetheless, market growth for high-dose opioid patches like DURAGESIC-100 will likely remain cautious, with a gradual decline projected in mature regions over the next five years.

Key Market Segments Influencing Financial Trajectory

Segment	Influence	Outlook
Geography	North America accounts for approximately 65% of sales, with Europe and Asia-Pacific showing growth potential	North America faces regulatory constraints; emerging markets may offer expansion opportunities
Patient Demographics	Elderly and cancer patients drive sustained demand	Growing aging populations favor long-term opioid use but increase scrutiny
Pricing & Reimbursement	Payer policies influence prescription volumes	Price pressures and formulary restrictions are expected to constrain margins
Innovation & Formulation	Advanced, abuse-deterrent patches can command premium pricing	Investment in safety features may rejuvenate market interest

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Conclusion

The market dynamics and financial trajectory of DURAGESIC-100 reflect a complex interplay of clinical benefits, regulatory controls, societal perceptions, and technological innovations. While the product remains a key player within the high-potency opioid segment, growth prospects are tempered by regulatory challenges and competitive pressures. Strategic positioning, continuous innovation, and regulatory compliance will determine Duragesic-100’s future financial performance.

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Key Takeaways

• Steady Market Presence: DURAGESIC-100 remains a significant player in managing severe chronic pain, especially in older adults and cancer patients.
• Regulatory Headwinds: Stricter opioid regulations, amid the ongoing opioid crisis, pose substantial risks to sales growth.
• Innovation Opportunities: Developing abuse-deterrent formulations and smart delivery systems can help sustain product relevance.
• Market Saturation and Competition: Generic competition and emerging therapies are exerting downward pressure on prices.
• Emerging Market Potential: Expanding into less regulated regions offers avenues for revenue diversification and growth.

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FAQs

1. How is the regulatory landscape impacting DURAGESIC-100's market?
Regulatory agencies such as the FDA and EMA have increased oversight of opioids, emphasizing misuse prevention. This translates into tighter prescribing guidelines, prior authorization requirements, and restrictions on high-dose formulations, generally constraining sales.

2. What technological innovations could influence DURAGESIC-100's future?
Developments in abuse-deterrent formulations, smart patches with dose monitoring, and alternative transdermal systems may enhance safety profiles, potentially expanding market acceptance and pricing power.

3. How does generic competition affect DURAGESIC-100's profitability?
Generic fentanyl patches offer lower-cost alternatives, pressuring branded products’ prices and margins. Janssen’s focus on safety features and brand loyalty aims to mitigate this impact.

4. What are growth prospects in emerging markets?
Growing healthcare infrastructure and prevalence of chronic pain conditions present opportunities. However, regulatory and reimbursement challenges must be addressed for successful expansion.

5. How might societal attitudes toward opioids influence DURAGESIC-100's trajectory?
Heightened awareness and regulatory measures due to the opioid epidemic could reduce prescribing volumes, affecting revenue. Conversely, safer formulations and risk mitigation strategies may counterbalance some adverse effects.

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References

1. MarketWatch. "Global Opioid Market Size, Share & Trends Analysis Report, 2022–2028."
2. World Health Organization. "Chronic Pain and Its Management," 2021.
3. U.S. Drug Enforcement Administration. "2023 Controlled Substances Act Regulations."
4. Janssen Pharmaceuticals. "Annual Financial Report 2022."