DURAGESIC-25 Drug Patent Profile

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 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-25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	4,384
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	4,060,084
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990	4,588,580*PED
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990	4,144,317

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/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
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
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

International Patents for DURAGESIC-25

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

Country	Patent Number	Title	Estimated Expiration
Spain	8707667
Spain	557179
Belgium	905568

Supplementary Protection Certificates for DURAGESIC-25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID

DURAGESIC-25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Duragesic-25 (Fentanyl Transdermal System)

Introduction

Duragesic-25, also known as the Fentanyl Transdermal System, is a potent opioid medication used for managing persistent severe pain in patients who are already tolerant to opioid therapy. This article delves into the market dynamics and financial trajectory of Duragesic-25, exploring its medical demand, regulatory environment, and the impact of illicit trafficking.

Medical Demand and Clinical Use

Duragesic-25 is part of a class of transdermal fentanyl patches that are equally efficacious in managing persistent pain as other potent opioids like buprenorphine[2].

• Clinical Efficacy: Studies have shown that fentanyl transdermal patches provide significant pain relief, with 50% of patients experiencing relief within the first three months, although sustained relief beyond six months is less common[2].
• Patient Demographics: The patient population typically includes those with chronic back pain and other long-term pain conditions, with a mean age of around 49 years and a significant proportion being female[2].

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of Duragesic-25.

• FDA Approval and Guidelines: The FDA has approved various strengths of fentanyl transdermal systems, including Duragesic-25, 50, 75, and 100 mcg/hour. These approvals come with stringent testing and quality control requirements to ensure bioequivalence and therapeutic equivalence to the reference listed drug[5].
• Risk Evaluation and Mitigation Strategy (REMS): Given the potential for abuse and overdose, the FDA often requires a REMS for fentanyl products, including generic versions. This adds a layer of complexity to the marketing and distribution of these drugs[5].

Market Competition and Generic Equivalents

The market for fentanyl transdermal systems is competitive, with multiple generic equivalents available.

• Generic Equivalents: Companies like Teva have developed generic versions of Duragesic, which must undergo rigorous testing to demonstrate bioequivalence. This competition can impact the pricing and market share of the original branded product[5].
• Patent Landscape: The patent landscape for fentanyl is complex, with numerous international and US patents, as well as ongoing patent litigation. This can influence the entry of new generic competitors and the overall market dynamics[3].

Illicit Trafficking and Its Impact

Illicit trafficking of fentanyl and its analogues significantly affects the legitimate market for Duragesic-25.

• Darknet Markets: Fentanyl and its analogues are widely available on darknet markets, where they are often distributed in small quantities via postal services. This illicit market can disrupt the legitimate supply chain and impact public health[1].
• Overdose Deaths: The rise in overdose deaths involving illicitly manufactured fentanyls (IMFs) is a major public health concern. This has led to increased regulatory scrutiny and public awareness campaigns, which can indirectly affect the prescription and use of legitimate fentanyl products[4].

Financial Trajectory

The financial trajectory of Duragesic-25 is influenced by several factors, including medical demand, competition from generics, and regulatory costs.

• Revenue and Market Share: The original branded product, Duragesic, has seen a decline in market share with the introduction of generic equivalents. However, the overall market for fentanyl transdermal systems remains substantial due to ongoing medical demand[3].
• Pricing Dynamics: The prices of fentanyl transdermal systems can vary significantly depending on the region and the presence of generic competitors. In the illicit market, the potency and low mass of fentanyl make it highly valuable, with significant price differentials compared to the legitimate market[1].

Impact of Regulatory Efforts

Regulatory efforts to control the opioid epidemic can have both direct and indirect impacts on the market for Duragesic-25.

• Supply Chain Monitoring: Increased monitoring of the supply chain to prevent diversion and misuse can add costs to the legitimate market. This includes enhanced tracking and reporting requirements[5].
• Public Health Campaigns: Public health campaigns aimed at reducing opioid misuse can affect prescribing patterns and patient demand for fentanyl products, potentially impacting sales and revenue[4].

User Demand for Harm Reduction

There is a notable user demand for harm reduction and self-medicated recovery among opioid users.

• Harm Reduction Products: The presence of opioid agonists like methadone, buprenorphine, and naloxone on darknet markets indicates a user demand for harm reduction strategies. This demand can influence the development and marketing of legitimate fentanyl products with built-in harm reduction features[1].

Regional Variations

The market dynamics and financial trajectory of Duragesic-25 can vary significantly across different regions.

• Global Market: The global market for fentanyl is influenced by regional regulatory environments, medical demand, and the presence of illicit trafficking. For example, the Australian market is particularly expensive due to stringent regulations and high demand[1].
• US Market: In the US, the market is heavily influenced by FDA regulations, patent litigation, and the ongoing opioid epidemic. The rise in IMF-involved deaths has led to increased scrutiny and regulatory actions[4].

Future Outlook

The future outlook for Duragesic-25 is complex and multifaceted.

• Medical Innovations: Ongoing medical research and innovations in pain management could lead to new products and therapies that might compete with or complement fentanyl transdermal systems[2].
• Regulatory Changes: Changes in regulatory policies, especially those aimed at controlling the opioid epidemic, will continue to shape the market dynamics and financial trajectory of Duragesic-25[5].

Key Takeaways

• Medical Demand: Duragesic-25 remains a crucial medication for managing persistent severe pain, with ongoing medical demand.
• Regulatory Environment: The regulatory landscape, including FDA approvals and REMS requirements, significantly influences the market.
• Illicit Trafficking: The illicit market for fentanyl impacts the legitimate market and public health.
• Financial Trajectory: The financial trajectory is influenced by competition from generics, regulatory costs, and regional variations.
• Future Outlook: The future is shaped by medical innovations, regulatory changes, and ongoing public health concerns.

FAQs

What is Duragesic-25 used for?

Duragesic-25, or the Fentanyl Transdermal System, is used for managing persistent severe pain in patients who are already tolerant to opioid therapy.

How does the FDA regulate Duragesic-25?

The FDA regulates Duragesic-25 through stringent testing and quality control requirements, including bioequivalence testing and REMS programs to mitigate the risk of abuse and overdose.

What is the impact of illicit trafficking on the market for Duragesic-25?

Illicit trafficking of fentanyl and its analogues disrupts the legitimate supply chain, affects public health, and can indirectly influence the prescription and use of legitimate fentanyl products.

How does competition from generic equivalents affect Duragesic-25?

Generic equivalents of Duragesic-25 compete for market share, potentially reducing the revenue and market share of the original branded product.

What are the regional variations in the market for Duragesic-25?

The market dynamics and financial trajectory of Duragesic-25 vary across regions due to differences in regulatory environments, medical demand, and the presence of illicit trafficking.

Sources

1. Australian Institute of Criminology: "Fentanyl availability on darknet markets"[1]
2. Pain Medicine: "Feasibility Study of Transdermal Buprenorphine Versus Fentanyl in Managing Persistent Pain"[2]
3. Drug Patent Watch: "Generic FENTANYL INN equivalents, drug patent expiry and more"[3]
4. CDC: "Trends in and Characteristics of Drug Overdose Deaths Involving Illicitly Manufactured Fentanyls"[4]
5. FDA: "Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour"[5]