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 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-50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	2,844
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
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990

EU/EMA Drug Approvals for DURAGESIC-50

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Ionsys	fentanyl	EMEA/H/C/000612 Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25
Teva B.V.	Effentora	fentanyl	EMEA/H/C/000833 Effentora 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
Takeda Pharma A/S	Instanyl	fentanyl	EMEA/H/C/000959 Instanyl 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
Kyowa Kirin Holdings B.V.	PecFent	fentanyl	EMEA/H/C/001164 PecFent 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
Incline Therapeutics Europe Ltd	Ionsys	fentanyl	EMEA/H/C/002715 Ionsys 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/002239 For the control of pain associated with orthopaedic and soft tissue surgery in dogs.	Withdrawn	no	no	no	2011-10-06

International Patents for DURAGESIC-50

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

Country	Patent Number	Title	Estimated Expiration
Germany	3546830	Transdermales Abgabesystem zur Verabreichung von Fentanyl (Device for delivering fentanyl across the skin)
Germany	3546869	Transdermales Abgabesystem zur Verabreichung von Fentanyl
Hong Kong	8191	TRANSDERMAL ADMINISTRATION OF FENTANYL AND DEVICE THEREFOR
Spain	557179
Switzerland	665351	TRANSDERMALES ABGABESYSTEM ZUR VERABREICHUNG VON FENTANYL.
United Kingdom	8514445

Supplementary Protection Certificates for DURAGESIC-50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION 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
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124

Market Dynamics and Financial Trajectory of DURAGESIC (Fentanyl Transdermal System)

Introduction

DURAGESIC, also known as the fentanyl transdermal system, is a potent opioid medication used for managing moderate to severe chronic pain in patients who are tolerant to opioid therapy. This article delves into the market dynamics and financial trajectory of DURAGESIC, exploring its clinical use, market presence, and economic implications.

Clinical Use and Indications

DURAGESIC is indicated for the management of persistent, moderate to severe chronic pain that cannot be managed by other means. It is particularly useful for patients who have developed tolerance to opioid therapy and require continuous pain relief[5].

Market Presence

Prescription Drug Market

DURAGESIC is a significant player in the prescription opioid market. It competes with other controlled-release opioids such as morphine and oxycodone. The market share of DURAGESIC is influenced by its efficacy, safety profile, and the specific needs of chronic pain patients.

Economic Evaluation

Studies have shown that DURAGESIC has a favorable cost-utility ratio compared to other opioids. For instance, the incremental cost-utility ratio of DURAGESIC versus morphine is approximately $20,709 per quality-adjusted life year (QALY), and versus oxycodone, it is around $5,273 per QALY[2].

Financial Trajectory

Costs Associated with Treatment

The total cost of treatment with DURAGESIC includes several components:

• Cost of Pain Medications: This is the most significant expense, with an average annual cost of $1,445.67[2].
• Cost of Rescue Medications: Patients may require additional medications for breakthrough pain, adding to the overall cost.
• Cost of Toxicity Management: Adverse events such as respiratory depression, nausea, and constipation incur additional costs for management and treatment[2].

Titration and Stabilization Costs

The initial titration phase involves adjusting the dose to achieve adequate pain relief. This phase incurs costs related to medical supervision and potential side effects. The expected total cost of titration is around $12.62, which is lower compared to morphine and oxycodone[2].

Long-term Use Costs

Long-term use of DURAGESIC involves ongoing costs for the medication itself, as well as costs associated with potential side effects and the need for dose adjustments. The total long-term use costs are approximately $40.51, which is comparable to other opioids[2].

Market Dynamics

Competition in the Opioid Market

DURAGESIC competes in a market dominated by other opioids such as morphine and oxycodone. The competition is driven by factors such as efficacy, safety, and cost. The market dynamics are also influenced by regulatory changes and the emergence of illicit opioids like fentanyl, which has significantly impacted the opioid market landscape[3].

Impact of Illicit Fentanyl

The rise of illicit fentanyl has disrupted traditional opioid markets, leading to increased overdose deaths and changes in user behavior. While DURAGESIC is a prescription medication, the broader opioid market dynamics are affected by the availability and potency of illicit fentanyl[1][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of DURAGESIC. Strict regulations on opioid prescriptions and distribution have been implemented to combat the opioid epidemic. These regulations can affect the availability and prescribing patterns of DURAGESIC, influencing its market share and financial trajectory[4].

Patient Demand and Adherence

Patient demand for DURAGESIC is driven by its effectiveness in managing chronic pain. However, adherence can be affected by side effects and the need for continuous medical supervision. Studies have shown that a significant number of patients discontinue treatment due to adverse events, which can impact the long-term financial performance of the drug[5].

Adverse Events and Safety Profile

DURAGESIC is associated with several adverse events, including nausea, vomiting, constipation, and respiratory depression. These side effects can lead to additional medical costs and impact patient adherence. The safety profile of DURAGESIC is a critical factor in its market dynamics, as it influences both prescribing decisions and patient outcomes[5].

Conclusion

DURAGESIC operates within a complex market influenced by clinical efficacy, safety profiles, regulatory environments, and the broader dynamics of the opioid market. Its financial trajectory is shaped by the costs associated with treatment, long-term use, and the management of adverse events. As the opioid market continues to evolve, understanding these factors is crucial for predicting the future market presence and financial performance of DURAGESIC.

Key Takeaways

• Clinical Use: DURAGESIC is indicated for managing moderate to severe chronic pain in opioid-tolerant patients.
• Market Presence: Competes with other controlled-release opioids like morphine and oxycodone.
• Economic Evaluation: Favorable cost-utility ratio compared to other opioids.
• Financial Trajectory: Influenced by costs of pain medications, rescue medications, and toxicity management.
• Regulatory Environment: Strict regulations on opioid prescriptions affect market dynamics.
• Patient Demand and Adherence: Driven by effectiveness but impacted by side effects.

FAQs

What is DURAGESIC used for?

DURAGESIC is used for the management of persistent, moderate to severe chronic pain in patients who are tolerant to opioid therapy.

How does DURAGESIC compare to other opioids in terms of cost?

DURAGESIC has a favorable cost-utility ratio compared to morphine and oxycodone, with incremental cost-utility ratios of $20,709 and $5,273 per QALY, respectively.

What are the common adverse events associated with DURAGESIC?

Common adverse events include nausea, vomiting, constipation, and respiratory depression.

How does the regulatory environment impact DURAGESIC?

Strict regulations on opioid prescriptions and distribution can affect the availability and prescribing patterns of DURAGESIC, influencing its market share and financial trajectory.

What is the impact of illicit fentanyl on the market dynamics of DURAGESIC?

The rise of illicit fentanyl has disrupted traditional opioid markets, leading to changes in user behavior and increased overdose deaths, which can indirectly affect the market dynamics of prescription opioids like DURAGESIC.

Sources

1. Australian Institute of Criminology - Fentanyl availability on darknet markets
2. Journal of Pain and Symptom Management - Economic Evaluation of the Fentanyl Transdermal System
3. Brookings Institution - The dynamics of US drug markets
4. CDC - Trends in and Characteristics of Drug Overdose Deaths Involving Illicitly Manufactured Fentanyls
5. Product Monograph - DURAGESIC (fentanyl transdermal system)