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:	5,294
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

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
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-100

See the table below for patents covering DURAGESIC-100 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)
Switzerland	665351	TRANSDERMALES ABGABESYSTEM ZUR VERABREICHUNG VON FENTANYL.

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
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
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906

Last updated: July 2, 2026

Duragesic-100 market dynamics and financial trajectory: sales trends, payer behavior, exclusivity, and generic erosion

Executive summary: DURAGESIC-100 (fentanyl transdermal system, 100 mcg/hr) is a mature, high-volume chronic-pain product with pricing and volume driven by (1) substitution patterns across fentanyl patch strengths and branded-to-generic switches, (2) payer formulary tiers for opioid analgesics, (3) safety-driven utilization controls, and (4) geography-specific generic availability once patent and exclusivity protections end. The financial trajectory is typically characterized by late-lifecycle revenue plateau followed by margin compression from generic entry and ongoing risk-management and REMS-influenced prescribing limits.

What matters for financial modeling: (i) the timing of generic and AB-rating conversions by strength, (ii) segment mix of opioid-naïve vs opioid-tolerant patients, (iii) utilization constraints from payer edits and prior authorization, and (iv) net price pressure from wholesale and pharmacy benefit manager (PBM) contracting.

---

What is DURAGESIC-100 and how does it sell in the opioid analgesic market?

Quick answer: DURAGESIC-100 is the 100 mcg/hr strength of fentanyl transdermal patch, a long-acting opioid analgesic used for persistent, severe pain requiring daily, around-the-clock treatment.

Key commercial drivers of patch fentanyl

• Strength-level dosing needs: Demand tracks with patient titration across patch strengths (25/50/75/100 mcg/hr). Strength 100 mcg/hr is a dose band for opioid-tolerant patients who have not stabilized on lower strengths.
• Switching friction: Unlike oral opioids where pill-strength substitution is straightforward, patch switching often involves conversion guidance, titration schedules, and payer approvals.
• Safety and monitoring: Utilization is affected by opioid safety policies, including dose optimization, risk mitigation messaging, and payer controls for high-risk cohorts.

Where DURAGESIC-100 sits in the product portfolio

• Within-category competition: Other fentanyl transdermal strengths and competitor formulations (different delivery technologies or generics) compete at the same therapeutic intent.
• Health-system influence: Managed-care formularies often align long-acting opioid selection with coverage restrictions and preferred product lists.

---

How have fentanyl patch formularies and payer restrictions affected DURAGESIC-100 demand?

Quick answer: Payer controls for opioid analgesics generally reduce inappropriate or high-risk utilization and push prescribers toward preferred products, typically accelerating generic uptake once available.

Common payer levers impacting market dynamics

• Prior authorization (PA): Often requires documentation of opioid tolerance and diagnosis appropriateness.
• Quantity limits: Caps initial and/or monthly patch supplies.
• Step therapy: Encourages trial of preferred long-acting opioids before access to a non-preferred brand.
• Exclusion edits and edit bursts: Claims adjudication edits can delay fills if dosing patterns or early refill behavior deviates from plan rules.

What those levers do to a 100 mcg/hr strength

• Stability bias: 100 mcg/hr is less frequently used as a first-line choice, which can support baseline demand but also limits addressable patient pools.
• Conversion responsiveness: Once generics are preferred, patients and prescribers convert as titration allows, causing relatively rapid post-entry share shift.

---

When do generics typically erode DURAGESIC-100 revenue and what timeline matters for forecasting?

Quick answer: Revenue erosion accelerates once (1) fentanyl patch generics at the relevant strength are AB-rated and widely covered, and (2) payer contracts set lower net prices for the preferred generic. The “cliff” effect is strength-specific and geography-specific.

Generic erosion mechanics to model

• AB-rating and interchangeability: If multiple generic fentanyl patches become substitutable, PBMs can mandate substitution at the pharmacy counter.
• Contracting cycles: Net price drops often lag regulatory approval by one or two contracting cycles.
• Switching lag for stable patients: Some patients remain on the same strength until the next scheduled titration interval.

Practical forecasting structure

• Pre-generic period: Price support from brand protection and limited formulary access.
• Launch-and-adoption period: Rapid channel movement driven by coverage updates and PBM preferred lists.
• Mature-generic phase: Ongoing unit volume loss for the brand and margin compression through further price competition among generics.

---

What patents protect DURAGESIC-100 and when do they expire?

No complete, citation-backed patent estate can be produced here. The provided prompt contains no patent publication numbers, Orange Book entries, NDA/ANDA identifiers, or jurisdictional filing details. Without those, any attempt to state patent expiration dates, coverage scope, or enforceability would be incomplete.

---

What is the Orange Book status of DURAGESIC-100 and does it list patents by formulation or method of use?

No complete, citation-backed Orange Book status can be produced here. The prompt does not provide the specific NDA number, application holder name(s), or Orange Book listing identifiers needed to enumerate patents, expiration dates, and listed exclusivities for DURAGESIC-100.

---

How strong is the patent estate for fentanyl patches like DURAGESIC-100?

No complete, citation-backed patent strength assessment can be produced here. Patent strength requires a dossier of claims-by-technology (composition, delivery system, manufacturing, dosage form, and method-of-use) and their legal posture.

---

Which generic entry risks exist for DURAGESIC-100 and what Paragraph IV patterns occur in this class?

No complete, citation-backed generic entry or Paragraph IV risk mapping can be produced here. Paragraph IV risk depends on ANDA filers, litigation records, Orange Book patent numbers, and settlement terms.

---

What DURAGESIC-100 patent litigation affects market access and generic launch timing?

No complete, citation-backed litigation timeline can be produced here. Litigation requires case captions, district courts, and docket outcomes tied to specific Orange Book patents.

---

How does DURAGESIC-100 compare with competing fentanyl patches in price, coverage, and switching rates?

Quick answer: In mature fentanyl patch markets, branded strength-level demand generally declines after generic preference, while remaining volume concentrates among patients who are stable on existing doses and prescribers who follow titration protocols rather than switching mid-cycle.

Competitive comparison dimensions

• Net price and rebate structure: Determines payer preference once generics exist.
• Formulary tier position: Drives patient access and retail pharmacy behavior.
• Strength coverage: Plans cover multiple strengths; market share shifts to the strength that best matches dosing and plan preferences.
• Safety controls: If one product has different REMS-like handling or package requirements, utilization can be affected, though for patches this is usually class-driven rather than product-specific.

---

What financial trajectory should be expected for DURAGESIC-100 under typical managed-care and generic pricing dynamics?

Quick answer: The financial trajectory generally moves from brand-stable revenue to net price compression after generic coverage, followed by unit share loss and margin decline. The magnitude depends on the timing of strength-specific generic penetration and the speed of PBM/plan contracting.

Scenario-based trajectory framework (for board-level modeling)

• Scenario 1: Delayed generic adoption

  • Brand revenue holds longer.
  • Price pressure is moderate, driven mainly by rebate renegotiation.
  • Margin erosion occurs later, with incremental unit loss after contracting.

• Scenario 2: Rapid strength-specific generic penetration

  • Net price falls quickly as preferred generic expands.
  • Brand unit volume declines as substitution occurs at the point of sale.
  • Margin compresses earlier due to higher rebate intensity required to maintain tier placement.

• Scenario 3: Narrow payer coverage and high PA burden

  • Brand may keep residual volume for patients requiring specific dosing support.
  • Generic entry may still erode share, but switching friction slows the decline.

Line items to tie to revenue and margin

• Gross-to-net: rebates, incentive fees, chargebacks, and payer-specific discounts.
• Channel mix: retail vs mail order; long-term care/health systems.
• Contracting: PBM formulary updates and national account coverage shifts.

---

What regulatory factors shape DURAGESIC-100 demand and reimbursement?

Quick answer: Regulatory influences are mostly class-level: opioid prescribing controls and safety communications affect prescribing rates and payer coverage criteria, limiting growth and reinforcing conservative dose titration.

Regulatory-driven market constraints to model

• Label and safety messaging adherence: Prescribers align prescribing to label dose conversion and opioid tolerance criteria.
• Risk management practices: Education requirements and monitoring guidelines can slow uptake in new patients.
• State-level prescribing policies: PDMP, opioid prescribing limits, and payer policies compound utilization friction.

---

How does geographic coverage affect DURAGESIC-100 sales and financial outcomes?

Quick answer: Geography determines the pace of patent expiry, generic approvals, and PBM contracting structures. Strength-level share shifts often happen earlier in markets with faster generic adoption and aggressive preferred contracting.

Geographic factors

• Approval and interchange rules: Determines whether generics are treated as interchangeable at the pharmacy counter.
• Reimbursement systems: Influences how quickly net pricing converges to generic reference pricing.
• Formulary governance: Centralized national formularies can cause step-change conversions; fragmented systems produce slower, channel-by-channel shifts.

---

Key Takeaways

1. DURAGESIC-100 is a mature fentanyl patch strength with demand largely driven by opioid tolerance, titration patterns, and managed-care access rules rather than new-patient category growth.
2. The financial trajectory is shaped by payer controls (PA, quantity limits, tiering) and opioid-safety policies that constrain initiation and drive conservative prescribing.
3. Revenue typically plateaus late in lifecycle, then declines as AB-rated fentanyl patch generics gain preferred status and pharmacy substitution accelerates.
4. Forecasting requires strength-specific generic adoption timing, PBM contracting cadence, and net-price deterioration from brand-to-generic switching.
5. Patent and Orange Book timelines, litigation effects, and generic entry risks cannot be stated here without application- and listing-level identifiers for DURAGESIC-100.

---

FAQs

1) How quickly do fentanyl patch brands lose share after generic entry?

Share loss depends on PBM preferred contracting and strength-level substitutability, but erosion typically accelerates after coverage changes that enable substitution at the point of sale.

2) Do payer prior authorizations reduce initiation or dose escalation for 100 mcg/hr fentanyl patches?

PA and quantity controls more often limit initiation and constrain rapid dose escalation, shifting utilization toward documented opioid-tolerant patients.

3) Does mail order pharmacy increase generic adoption for long-acting opioid patches?

Mail order often increases generic throughput because it adheres to PBM formulary logic and can standardize preferred product substitution.

4) Are fentanyl patch revenues more sensitive to net price or unit volume?

In mature markets, net price compression and rebate renegotiation usually drive margin deterioration; unit volume loss follows as substitution and formulary tiering shift.

5) How do opioid safety policies affect long-term revenue growth for fentanyl patch strengths?

Policies that reduce inappropriate prescribing and require monitoring typically cap growth and can shift mix away from higher utilization cohorts.

---

References

1. (No citations provided because no Orange Book, NDA application identifiers, patent listings, litigation dockets, or financial disclosures were supplied in the prompt.)