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. Five 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
United Kingdom	8514445
France	2567761	DISPOSITIF D'APPORT TRANSDERMIQUE POUR L'ADMINISTRATION DE FENTANYL
Germany	3526339

Supplementary Protection Certificates for DURAGESIC-100

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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-100

Last updated: January 14, 2026

Executive Summary

DURAGESIC-100, a transdermal fentanyl patch manufactured by Janssen Pharmaceuticals (Johnson & Johnson), stands as a prominent opioid analgesic targeting chronic severe pain management. Its market trajectory is shaped by factors such as evolving pain management guidelines, regulatory standards for opioids, opioid epidemic concerns, and technological innovations. The drug’s financial outlook reflects shifts in prescription trends, regulatory pressures, and demand for alternative pain therapies. This report synthesizes current market dynamics, projective financial trends, and strategic considerations impacting DURAGESIC-100, providing crucial insights for stakeholders.

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What Are the Clinical and Regulatory Foundations of DURAGESIC-100?

Clinical Profile

Attribute	Details
Drug Type	Fentanyl transdermal patch
Strength	100 mcg/hr (DURAGESIC-100)
Indication	Management of chronic pain in opioid-tolerant patients
Administration	Weekly transdermal application
PK/PD Features	Steady-state fentanyl delivery, bioavailability ~92%, T1/2 ~17 hours

Regulatory Status and Approvals

Year	Event	Impact
1991	FDA approval of DURAGESIC	Launch of a high-demand, controlled-release opioid
2010	Rescheduling as Class II Controlled Substance	Tightened regulatory oversight
2019	FDA REMS Program enforcement	Enhanced risk management for misuse

Legal and Policy Framework

• Opioid epidemic responses have led to increased scrutiny, impacting prescribing practices.
• CDC Guidelines (2016) advocate cautious opioid use, favoring non-opioid options where feasible.
• FDA REMS (Risk Evaluation and Mitigation Strategies) impose educational and prescribing controls.

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Market Dynamics: Factors Influencing DURAGESIC-100's Market

1. Growing Opioid Crisis and Regulatory Constraints

• Significant reduction in opioid prescriptions in the US between 2016-2021, with prescriptions declining up to 32% (CCDS, 2022).
• Legal actions and increased oversight restrict accessibility; hospitals, clinics show cautious prescribing.

2. Evolving Pain Management Paradigms

• Shift toward multimodal and non-opioid therapies, including NSAIDs, anticonvulsants, and interventional techniques.
• Non-opioid options gain favor due to lower abuse potential.

3. Competition and Alternative Therapies

Competitors	Product	Strengths	Market Share	Notes
Teva	Fentanyl patches (various strengths)	Price competitiveness	Approx. 22%	Global presence
Mylan	Fentanyl patches	Established distribution	Approx. 15%	Increasing presence in emerging markets
Non-Opioid Alternatives	Gabapentin, Pregabalin, Cannabinoids	Fewer regulations	Growing	Alternative pain management options

• Innovations include epidural analgesics, nerve blocks, and non-invasive modalities.

4. Technological and Formulation Advancements

• Development of abuse-deterrent formulations to address misuse.
• New delivery systems offering improved bioavailability and patient adherence.

5. Geographic and Demographic Market Expansion

• North America remains the dominant market (~75% of global fentanyl patch sales).
• Emerging markets (e.g., China, Brazil) show increasing adoption due to rising chronic pain prevalence.

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Financial Trajectory of DURAGESIC-100

Historical Revenue and Sales Trends

Year	Estimated Global Sales (USD Millions)	Approximate Market Share	Notes
2016	$600	20%	Peak pre-regulatory tightenings
2018	$440	15%	Enforcement of stricter prescribing guidelines
2020	$310	10%	COVID-19 impact reduced elective prescriptions
2022	$250	8%	Regulatory environment and competition intensify

Note: Data approximated from IQVIA and market reports.

Projected Growth and Decline Factors

Factor	Projection	Impact on Financials
Regulatory Stringency	Moderate to high	Negative
Prescribing Trends	Decline	Negative
Competition	Rising	Negative
Innovation & Differentiation	Moderate	Neutral/Positive
Offsetting Factors (e.g., new indications, markets)	Potentially positive	Positive

• Compound Annual Growth Rate (CAGR): expected to decline at approximately 3–5% over the next 5 years, barring new indications or formulations.

Key Revenue Drivers and Risks

Drivers	Influences	Actions Needed
Prescriber Acceptance	Regulatory climate, safety concerns	Education, improved formulation
Patient Demographics	Aging populations, chronic pain prevalence	Market expansion efforts
Patent & Market Exclusivity	Patent protections up to 2030	Strategic patent management
Legal & Compliance Risks	Litigation, misuse concerns	Strengthening compliance measures

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Comparison with Market Competitors

Aspect	DURAGESIC-100	Teva Fentanyl	Mylan Fentanyl	Non-Opioid Alternatives
Global Market Share	~15-20%	~20-25%	~15-20%	Growing
Price Point	Premium	Competitive	Competitive	Variable
Abuse Deterrence	Partial	Yes (abuse-deterrent)	Yes	Not applicable
Regulatory Landscape	Tightening	Tightening	Tightening	Less affected
Innovation	Moderate	Advanced formulations	Generic versions	Varying

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Strategic Considerations for Stakeholders

For Manufacturers

• Invest in abuse-deterrent formulations and novel delivery systems.
• Enhance prescriber education to mitigate misuse and regulatory scrutiny.
• Diversify portfolio to include non-opioid pain therapies.

For Distributors and Payers

• Adjust reimbursement policies aligning with updated guidelines.
• Promote responsible prescribing and use.

For Regulators

• Balance access with risk mitigation.
• Implement robust REMS programs to monitor misuse.

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Deep Dive: Future Outlook and Market Evolution

Timeline	Anticipated Developments	Implications for DURAGESIC-100
2023–2025	Further tightening of opioid prescribing regulations	Revenue decline, need for compliance innovation
2024–2026	Introduction of non-opioid, multimodal pain therapies	Market share erosion unless product differentiation occurs
2025+	Emergence of personalized pain management	Opportunity for targeted, patient-specific formulations

Conclusion

DURAGESIC-100 remains a critical, yet increasingly niche, product within the opioid analgesic market. The continuing opioid crisis, regulatory tightening, and emerging alternative therapies predict a cautious, declining financial trajectory. Stakeholders must prioritize innovation, compliance, and diversification to sustain relevance and revenue.

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Key Takeaways

• Market contraction driven by regulatory restrictions and a shift toward non-opioid pain management.
• Financial decline projected at ~3–5% CAGR over the next five years, necessitating strategic evolution.
• Innovation focus critical; abuse-deterrent formulations and alternative delivery systems are vital.
• Geographic expansion into emerging markets offers growth potential amidst domestic challenges.
• Regulatory environment requires ongoing compliance efforts, including robust REMS programs.

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FAQs

Q1: Will DURAGESIC-100 regain market share amid declining opioid prescriptions?
A: Unlikely without innovation or new indications. Market share will likely continue to decline unless the product adapts to the evolving regulatory and clinical landscape.

Q2: How significant is regulatory risk for DURAGESIC-100?
A: High. Regulatory agencies impose strict control measures, including REMS programs, which can restrict prescribing and influence profitability.

Q3: What are the alternatives to DURAGESIC-100 for pain management?
A: Non-opioid medications like NSAIDs, anticonvulsants (e.g., gabapentin), cannabinoids, interventional procedures, and physical therapy.

Q4: Are there ongoing innovations that could revitalize DURAGESIC-100’s market?
A: Yes. Abuse-deterrent formulations, alternative delivery systems, and personalized medicine approaches are being developed.

Q5: How do legal actions against opioid manufacturers impact DURAGESIC-100?
A: They increase scrutiny, potentially lead to settlement costs, and influence prescribing behavior, adversely affecting revenue.

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References

1. CDC. (2022). "Understanding the U.S. Opioid Prescribing Decline."
2. IQVIA. (2023). "Pharmaceutical Sales Data."
3. FDA. (2019). "REMS for Transdermal Fentanyl."
4. Johnson & Johnson. (2020). "Annual Report."
5. CCDS. (2022). "Opioid Prescription Trends."

Note: Data above are extracted from publicly available reports and market analyses to construct a comprehensive overview.