DURAGESIC-25 Drug Patent Profile

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When do Duragesic-25 patents expire, and when can generic versions of Duragesic-25 launch?

Duragesic-25 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-25 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-25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,766
DailyMed Link:	DURAGESIC-25 at DailyMed

Recent Clinical Trials for DURAGESIC-25

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-25 clinical trials

US Patents and Regulatory Information for DURAGESIC-25

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-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990		DISCN	Yes	No

Expired US Patents for DURAGESIC-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990

EU/EMA Drug Approvals for DURAGESIC-25

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-25

See the table below for patents covering DURAGESIC-25 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	4452785
Australia	565177
Belgium	902884
Belgium	905568
Canada	1245983	ADMINISTRATION TRANSCUTANEE DE FENTANYL, ET DISPOSITIF POUR CE FAIRE (TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR)

Supplementary Protection Certificates for DURAGESIC-25

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
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006

Last updated: July 4, 2026

Duragesic-25 market dynamics and financial trajectory: revenue exposure, competitive pressure, and exclusivity risk

Duragesic-25 (fentanyl transdermal system, 25 mcg/hr) is an established opioid patch franchise with mature market dynamics dominated by payer access, channel inventory behavior, and ongoing generic/biosimilar-style competitive substitutes (generic transdermal fentanyl products). Public financial outcomes for the branded product are tightly linked to (1) patent and exclusivity status of the reference product and (2) uptake of therapeutically equivalent generics that compress net pricing over time. Where the remaining revenue is concentrated is primarily in the US retail and institutional payer segments that maintain limited formulary restrictions versus segments that already shifted to generic equivalents earlier in the lifecycle.

What is Duragesic-25 and how is it positioned in the fentanyl transdermal opioid market?

Duragesic-25 is the 25 mcg/hr strength of fentanyl transdermal delivery, a controlled-substance opioid indicated for management of severe chronic pain that requires continuous opioid treatment and for which alternative options are inadequate (labeling varies by jurisdiction). In practice, market positioning is shaped by:

• Dosage breadth within the transdermal fentanyl class: Duragesic’s strength ladder (including 25 mcg/hr) supports titration from initiation doses.
• Switching behavior: Patients and prescribers may remain on a branded patch due to perceived consistency, but payers drive switching to lower-cost equivalents.
• Supply chain constraints for controlled substances: small changes in allocation and inventory can influence quarterly sales swings.

H2O: How does Duragesic-25 compare with other transdermal fentanyl products on access and substitution?

Key competitive dynamics across the transdermal fentanyl class:

• Generic substitution for fentanyl transdermal systems is common once products are therapeutically equivalent.
• Formulary tiers are typically driven by net price and rebate contracts.
• State-level opioid policies influence prescribing and may shift volume to lower-cost options.

Where does Duragesic-25 revenue come from and what are the main market drivers?

Revenue drivers typically include:

1. Payer contracting and rebate structure: Net pricing moves more than gross list price.
2. Formulary placement: Brand patches lose margin if they are de-tiered or require prior authorization.
3. Utilization stability vs opioid demand: Opioid utilization is capacity-limited by safety policies and monitoring requirements, but chronic pain populations remain relatively stable.
4. Channel inventory: Retail and wholesaler inventory for controlled substances can lead to quarterly under/overhang dynamics.

How do wholesalers and retail buying patterns affect quarterly Duragesic-25 sales?

For controlled-substance patches, quarterly sales can show volatility due to:

• Order timing tied to distribution schedules.
• Inventory normalization after shortages or policy-driven demand spikes.
• Payer-driven switching that can start suddenly after contracting renegotiations.

What do payer dynamics and formulary restrictions do to Duragesic-25 net price?

Duragesic-25 net revenue is most sensitive to:

• Preferred vs non-preferred status on pharmacy benefit formularies.
• PA/step-therapy adoption for opioid patches.
• Contracting with PBMs where multiple fentanyl patches compete at different tiers.

Operational pattern in mature opioid patch categories:

• After generic entry, branded net price declines even when volume remains partly resilient.
• Over time, branded share often erodes as formularies standardize on low-cost equivalents.

When does Duragesic-25 lose exclusivity, and what does that mean for revenue trajectory?

For a generic-heavy category, “exclusivity” has two layers:

• Patent-driven exclusivity (including Orange Book-listed protection).
• Regulatory exclusivity (ex: NCE/505(b)(1)/(2) exclusivities where applicable) and any pediatric exclusivity impacts.

Net effect for an older opioid patch:

• After patent cliffs, branded patch revenues typically transition from growth to steady decline (or flat to modest erosion) as generics capture incremental volume.

How strong is the patent estate for fentanyl transdermal systems like Duragesic-25?

Patent estates for transdermal fentanyl products commonly cover:

• Drug substance and dosage form compositions
• Manufacturing methods
• Specific patch formulations and design improvements
• Method-of-use claims (less common for established indications but appears in some estates)
• Process and control-related claims that can delay or shape generic launch strategies

Which patents protect Duragesic-25 in the US, and how do they influence generic entry risk?

US protection and generic entry risk are determined by:

• FDA Orange Book listings for the reference product (Duragesic) and protected patents.
• Litigation history tied to Paragraph IV or other challenges.

What is the Orange Book status of Duragesic-25?

Orange Book status determines whether a generic applicant must be blocked until:

• expiration of the latest expiring patent, or
• a litigation outcome allowing launch despite unexpired listed patents (through settlement, court rulings, or non-infringement determinations).

For precise listing-level analysis (patent numbers, assignees, and listed expiration dates), the required Orange Book records must be matched to the specific strength “Duragesic-25” and the current label/application family. Without those records in the available input, a definitive patent-by-patent exclusivity map cannot be produced here.

What generic entry risks exist for Duragesic-25?

Generic entry risk in mature transdermal fentanyl categories typically manifests through:

• Therapeutic equivalence adoption by prescribers once market confidence forms.
• Formulary switching after PBM contracts refresh.
• Price compression where multiple ANDA-generic products compete.

Do settlement agreements reduce or accelerate Duragesic-25 erosion?

In Hatch-Waxman disputes, settlements can:

• set a delayed launch date,
• allow “at-risk” supply earlier for certain challengers,
• or remove barriers if the settlement permits immediate launch.

The financial trajectory depends less on headline court outcomes and more on:

• net price after launch,
• brand retention under PA and clinical-use constraints,
• and the number of entrants (single entry vs multi-generic competition).

What patent litigation affects Duragesic-25, and how does it change the forecast?

In the fentanyl patch market, litigation generally shapes:

• timing of generic launches,
• design-around scope (whether a challenger uses different patch technology or formulation),
• and whether the brand gains time via injunctions or loses protection via invalidity findings.

A defensible litigation timeline requires docket-level case identification tied to the Duragesic reference product and the ANDA challengers. That case-specific dataset is not present in the available material, so a fact-anchored litigation forecast cannot be generated here.

What is the FDA regulatory status of Duragesic-25, and how does it affect commercialization?

For branded transdermal opioid products, FDA status impacts:

• manufacturing continuity,
• label changes that can alter PBM and provider comfort,
• and the permissibility of certain distribution strategies.

Regulatory considerations in commercialization:

• controlled substance handling requirements
• pharmacovigilance and REMS-like controls where applicable (opioid programs vary by era and agency approach)
• post-approval manufacturing changes that can impact supply reliability

How many players compete with Duragesic-25, and what is the competitive landscape?

Competitive set at the strength level is typically:

• brand reference product (Duragesic and its versions)
• multiple ANDA generics across strengths
• sometimes alternative fentanyl transdermal systems (different brand/generic patch technologies)

What pricing and share dynamics typically occur in fentanyl transdermal competition?

When several generics exist:

• net prices trend toward lowest-contract pricing,
• branded share becomes concentrated in non-preferred segments, and
• pharmacy-level substitutions become routine.

How does Duragesic-25 compare with competing fentanyl patch products in the US?

A full comparison requires:

• competitor product list at 25 mcg/hr,
• each product’s net pricing trajectory and formulary tier status,
• substitution rate evidence.

Without a product-by-product competitor dataset, a quantitative comparison table cannot be produced here without risking inaccuracies.

What is the financial trajectory for Duragesic-25: growth, decline, and revenue exposure?

For mature prescription brands in a generic-exposed opioid category, financial trajectory generally follows:

• declining branded net sales after key exclusivity sunsets
• possible stabilization if generic competition is limited or access is constrained
• ongoing erosion if multiple competitors enter and PBMs rebid aggressively

Revenue exposure framework for Duragesic-25

A practical exposure model includes:

• US share of branded patch revenue
• gross-to-net compression after generic entry
• mix shift across strengths (25 mcg/hr can be titration-linked and may be either a “bridge” strength or a stable chronic dose segment)
• payer channel mix (retail vs institutional)

A precise revenue forecast (numbers by year) requires financial statements for the brand owner and segment reporting tied to the patch franchise. No such brand-level financial dataset is provided in the input, so a quantified trajectory cannot be constructed.

Key timelines analysts should track for Duragesic-25 (what to model each quarter)

Because the market is exclusivity- and access-driven, the forecast should be recalculated around:

• Orange Book patent expirations (latest-expiring)
• launch dates of generic fentanyl transdermal equivalents
• PBM formulary rebids and tiering changes
• controlled-substance inventory shocks
• label updates that drive prescriber switching (or slow it)

Duragesic-25 forecast timeline checklist

• Patent latest-expiring date updates
• ANDA approval dates for 25 mcg/hr strength equivalents
• Launch timing and first-quarter market share capture
• PBM tier moves and PA expansion for non-preferred brands
• Any litigation outcomes that shift the effective launch calendar

What are the business implications for licensing, litigation, and market entry?

Licensing strategy

In mature transdermal opioid classes, licensing value typically concentrates on:

• formulation IP that supports differentiation,
• manufacturing process control and supply reliability,
• and any remaining “evergreen” improvements that can delay generic entry.

Litigation posture

For brand owners, litigation value comes from:

• maintaining exclusivity to protect gross-to-net during early generic entrants,
• preventing “at-risk” launch that accelerates price compression,
• and narrowing generic design-around.

For generics, litigation posture centers on:

• invalidity/non-infringement arguments tied to listed patents,
• settlement terms that provide launch certainty.

Key Takeaways

• Duragesic-25’s revenue trajectory is predominantly governed by generic competitive substitution and payer net pricing, not by incremental clinical differentiation.
• The market can show quarterly volatility due to channel inventory behavior in controlled-substance distribution.
• The most critical forecast levers are Orange Book latest-expiring protections, generic launch timing, and PBM formulary tier changes that drive switching.
• A quantified financial trajectory and patent-by-patent exclusivity map require Orange Book and litigation datasets tied to “Duragesic-25” and its reference NDA application family, which are not included in the available input.

FAQs

1. What Orange Book patents are listed for Duragesic 25 mcg/hr fentanyl transdermal systems?
2. How quickly do PBMs switch to generic fentanyl transdermal patches after the first launch?
3. What factors drive gross-to-net compression for opioid patch brands like Duragesic?
4. Do settlements in fentanyl patch Hatch-Waxman cases delay generic launches or accelerate at-risk entry?
5. Which payer policies most impact prescribing volume for fentanyl transdermal 25 mcg/hr dosing?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
2. FDA. Drug Approval Reports and Labeling for fentanyl transdermal systems. (Accessed via Drugs@FDA database).