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 is one drug master file entry 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:	4,608
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

International Patents for DURAGESIC-50

See the table below for patents covering DURAGESIC-50 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	4452785
Australia	565177
Belgium	902884

Supplementary Protection Certificates for DURAGESIC-50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

Last updated: July 2, 2026

Duragesic-50 (fentanyl transdermal system) market dynamics and financial trajectory

Executive summary: DURAGESIC-50 (fentanyl transdermal system, 50 mcg/hr) is a long-established, high-cost-to-healthcare but low-volume-per-prescription opioid analgesic. The market is shaped by (1) opioid prescribing controls and payer utilization management, (2) safety-focused education and REMS-adjacent risk management, (3) rapid substitution among branded and generic fentanyl patches, and (4) acquisition and supply-chain dynamics across North America and EU markets. Commercial performance tracks overall fentanyl patch demand for “opioid-tolerant” chronic pain, with revenue sensitivity to formulary access, gross-to-net pressure, and competitive product mix (authorized generics and multiple supplier SKUs).

What drives demand for DURAGESIC-50 fentanyl 50 mcg/hr transdermal patches?

Core demand drivers

• Chronic severe pain requiring continuous opioid analgesia, where fentanyl patches are used for sustained delivery (opioid-tolerant populations).
• Formularies that prefer transdermal fentanyl over short-acting opioids for selected patient segments.
• Prescriber comfort with transdermal dosing when titration is stable.

Key market constraints

• Opioid risk controls: prescriber monitoring, prior authorization, quantity limits, and tighter rules around opioid initiation.
• Safety scrutiny: overdose risk, misuse and diversion monitoring, and education requirements.
• Patent and exclusivity erosion for legacy branded fentanyl products, pushing net pricing down even when units persist.

Payer and channel mechanics

• High gross-to-net typical of specialty analgesics under coverage constraints.
• Preferred status often determined by rebate structure and manufacturer contracting, not by therapeutic differentiation.

How does opioid policy and payer utilization management affect DURAGESIC-50 sales?

Utilization management levers

• Prior authorization for dose escalation and opioid-tolerant confirmation.
• Step edits that route certain patients to less restrictive alternatives before DURAGESIC-50.
• Quantity limits based on days supply and early refill denial policies.

Prescribing environment

• Increased adherence to opioid stewardship guidelines tends to reduce initiation volumes.
• Continuing therapy in stable opioid-tolerant patients remains the revenue anchor; the “new starts” pipeline is more volatile.

Net pricing and margin pressure

• Broader generic penetration in fentanyl patch categories increases plan leverage.
• Rebates and chargebacks intensify as competitors compete for formulary position.

When does DURAGESIC-50 lose exclusivity or face generic substitution risk?

Market-level reality

• DURAGESIC is a legacy fentanyl patch brand. In most jurisdictions, generic fentanyl patches and authorized generics already exist, so exclusivity today is driven less by headline brand patent life and more by:
  • residual patent coverage on specific strengths, formulations, or manufacturing processes
  • lifecycle management (device/adhesive changes, stability improvements, labeling changes)
  • regulatory exclusivity (where applicable) and settlement-derived launch calendars

Generic launch dynamics that matter for revenue

• Pricing compression accelerates after entry into major formularies.
• Switch timing often lags FDA approval by 1 to 3 quarters due to contracting cycles and pharmacy switching protocols.
• SSAs and wholesalers influence order patterns; supply availability can shape quarterly units.

What is the Orange Book status of DURAGESIC-50 fentanyl transdermal system?

Featured snippet answer: DURAGESIC-50’s Orange Book footprint includes the reference listed drug (RLD) for fentanyl transdermal system and corresponding strengths; competing ANDA products for fentanyl patches typically appear as multiple applicants across strengths and dosage forms.

How to interpret Orange Book signals for financial modeling

• Number of ANDA applicants in the same dosage strength category is a leading indicator of expected pricing pressure.
• Litigation or “no launch” commitments can delay substitution and support temporary pricing stability.
• If multiple ANDAs list “same as” strengths with rapid approval dates, market share churn tends to be fast once contracting is complete.

Which patents protect fentanyl transdermal products like DURAGESIC-50?

Patent estate typical for fentanyl patch families

• Formulation and composition of the drug-in-adhesive matrix (rate-controlling components, stability and permeation tuning).
• Manufacturing methods (adhesive coating processes, patch assembly, solvent handling, quality controls).
• Device-related claims (backing layer, release liner, membrane structure, heat sealing or lamination approach).
• Method-of-use claims can appear for dosing regimens or patient selection, but for opioid analgesics the most enforceable claims often sit in formulation/device rather than in broad prescribing indications.

Practical impact on DURAGESIC-50 economics

• If enforceable patents cover manufacturing/device features unique to the brand patch, generic entry may be limited or segmented to certain strengths.
• If patents have largely expired for core fentanyl patch constructs, the market behaves like a commoditized transdermal opioid category with pricing driven by rebate competition.

What formulations are protected in the fentanyl patch market and how do they affect competition?

Formulation competition

• Many fentanyl patch ANDAs must demonstrate “bioequivalence” and comparable drug release. When formulation changes are required, applicants often tailor adhesive composition or membrane structure.
• If the reference product uses specific excipient combinations with long-standing know-how, generic entrants may face additional process validation constraints, creating temporary supply lags.

Financial linkage

• Process complexity and scale-up success affect fill rates and contracting leverage.
• Supply disruptions can temporarily raise prices even in a generic-heavy landscape, but they rarely extend long.

What patent litigation has affected fentanyl patch brands like DURAGESIC?

Typical litigation patterns in this category

• Paragraph IV certifications tied to formulation/device patents.
• Distribution of cases across strengths rather than the entire brand: one strength can be blocked while others launch.
• Settlement agreements often include delayed launch dates, limited-scope stipulations, or shared supply arrangements.

Financial effects to model

• Court or settlement timing shifts forecasted share loss from “on day 1 of approval” to “after contracting and court-enforced delay.”
• Even absent a full brand shutdown, litigation can suppress the most aggressive price erosion.

How does DURAGESIC-50 compare with other fentanyl patches commercially?

Competitive set

• Branded legacy fentanyl patches (historically multiple manufacturers) versus generic fentanyl patch equivalents across 12, 25, 50, 75, 100 mcg/hr strengths.
• Authorized generic offerings in US channel.

How “50 mcg/hr” typically behaves

• Mid-dose strengths often serve as a step-up segment from lower doses for stable opioid-tolerant patients.
• Revenue sensitivity is high to substitution among adjacent strengths (25 and 75 mcg/hr) because prescribers adjust dose within small increments.

Mix effect

• A shift from 50 mcg/hr to adjacent strengths can move dollars without reducing total fentanyl patch volume.
• Manufacturers compete not only on price but on package configuration, availability, and wholesaler contracting.

What is the biosimilar risk for DURAGESIC-50?

Featured snippet answer: Biosimilar risk is not the primary threat category for DURAGESIC-50. DURAGESIC-50 is a small-molecule fentanyl transdermal system; the primary competitive risk is generic substitution (ANDAs), not biosimilars.

What FDA regulatory status and approvals shape DURAGESIC-50 market access?

Regulatory determinants

• Labeling for “opioid-tolerant” patients and continuous pain management is central to safe use restrictions and payer coverage decisions.
• Updates to risk communication, dosing instructions, and safety monitoring can affect utilization.

ANDAs and market entry

• FDA approval of additional ANDAs for fentanyl patch strengths increases choice for payers and pharmacies.
• When new entrants demonstrate bioequivalence and compliant manufacturing, they typically gain formulary access through aggressive contracting.

What are the main manufacturing and supply-chain barriers for competitors entering fentanyl patches?

Manufacturing constraints

• Consistent adhesive coating, uniform drug loading, and reliable drug release profile.
• Quality system compliance under GMP for transdermal delivery, where small process deviations can change release kinetics.
• Packaging and cold chain handling are usually less critical than for biologics but still require robust stability and shelf-life controls.

Supply-chain factors that affect quarterly revenue

• Shortages can delay substitution and protect the incumbent.
• Overproduction by entrants can accelerate discounting to clear inventory.

How do revenue, pricing, and unit dynamics typically evolve after generic entry for fentanyl patches?

Market behavior in generic-heavy categories

• Units often hold up longer than revenue because clinicians remain comfortable with stable dosing and pharmacies maintain on-hand inventory.
• Gross-to-net increases as incumbents add contracting pressure to defend shelf share.
• Net price declines lead the financial trajectory, not necessarily volume decline.

Where DURAGESIC-50 sits

• If the brand remains the RLD reference and has residual differentiators (availability, contracting strength, or limited blocking), revenue can decline gradually.
• If multiple ANDAs have already launched and are interchangeable at the pharmacy counter, revenue typically follows a faster net pricing compression curve.

Regional market dynamics: US vs EU vs other jurisdictions

United States

• Highest intensity of generic penetration and formulary competition.
• Payer controls and opioid stewardship drive utilization management.
• Litigation can affect specific strengths and delay some price declines temporarily.

Europe

• Reimbursement structures and substitution rules differ by country.
• Transdermal fentanyl access and use guidelines vary by national opioid policy and monitoring systems.
• Multi-country contracting and tendering can smooth or accelerate brand-to-generic transitions.

Other markets

• Regulatory harmonization and import channels govern availability.
• Pricing is influenced by local reimbursement frameworks and the maturity of generic competition.

Financial trajectory model for DURAGESIC-50: what to watch each quarter

Quarterly KPIs

• Net sales vs unit sales: net sales are expected to decline faster post-substitution.
• Gross-to-net ratio: rising rebates signal defensive contracting or increased plan pressure.
• Mix across strengths: watch shifts between 25, 50, 75 mcg/hr.
• Trade inventory: wholesaler pull-through affects reported sell-in.

Share defense levers

• Contracting and formulary inclusion timing (NA channels).
• Supply reliability and packaging configurations.
• Targeted payer managed entry agreements where allowed.

Key Takeaways

• DURAGESIC-50’s commercial performance is mainly driven by chronic severe pain demand in opioid-tolerant patients, then shaped by opioid stewardship and payer utilization management.
• The primary competitive threat is generic substitution across fentanyl patch strengths, with revenue sensitivity driven by gross-to-net compression and mix shifts rather than by biosimilar competition.
• Patent and litigation effects, when present, tend to be strength-specific and influence launch timing and contracting windows, which can materially change the revenue curve quarter-to-quarter.
• For forecasting, model net sales first through pricing and contracting changes, then overlay unit stability and strength-mix dynamics.

FAQs

1. Does DURAGESIC-50 have more generic competition than other fentanyl patch strengths?
   Competition intensity depends on how many ANDAs are approved and positioned for the 50 mcg/hr strength and how quickly payers contract, not on strength alone.

2. How quickly do payers switch fentanyl patch prescriptions after ANDA launches?
   Switching typically follows FDA approval with delays driven by rebate negotiations, formulary committee cycles, and pharmacy substitution workflows.

3. Do opioid stewardship programs reduce fentanyl patch units or mainly affect new starts?
   Programs more directly impact new starts and opioid initiation; established opioid-tolerant use can remain steadier.

4. What claims are most likely to drive fentanyl patch litigation outcomes?
   Formulation and manufacturing/device process claims tend to be most litigated and most determinative for generic design-around feasibility.

5. Is supply reliability a meaningful driver of brand fentanyl patch revenue during generic ramp-up?
   Yes. During early generic ramp-up or shortages, incumbents with reliable supply can defend market access and fill rates, delaying share loss.

References

(No sources were provided in the prompt, and no citationable data (Orange Book entries, specific patent numbers, litigation docket outcomes, or financial statement figures) can be supplied without external inputs.)