DURAGESIC-12 Drug Patent Profile

Which patents cover Duragesic-12, and what generic alternatives are available?

Duragesic-12 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-12 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-12

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	4,418
DailyMed Link:	DURAGESIC-12 at DailyMed

Recent Clinical Trials for DURAGESIC-12

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-12 clinical trials

US Patents and Regulatory Information for DURAGESIC-12

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-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-005	Feb 4, 2005		DISCN	Yes	No

EU/EMA Drug Approvals for DURAGESIC-12

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-12

See the table below for patents covering DURAGESIC-12 around the world.

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

Supplementary Protection Certificates for DURAGESIC-12

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-12 Market Analysis and Financial Projection Experimental

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

Introduction

DURAGESIC, a transdermal fentanyl patch, is a potent opioid analgesic used for managing severe, chronic pain in opioid-tolerant patients. This article delves into the market dynamics and financial trajectory of DURAGESIC, highlighting its usage, regulatory environment, and the broader impact of opioid market trends.

Indications and Usage

DURAGESIC is indicated for the management of pain in opioid-tolerant patients who require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. It is available in various strengths, ranging from 12 mcg/hour to 100 mcg/hour[4].

Market Demand and Patient Profile

The demand for DURAGESIC is driven by the need for effective pain management in patients with severe chronic pain. These patients are typically those who have been taking high doses of opioids for an extended period, such as at least 60 mg oral morphine per day or equivalent doses of other opioids[4].

Regulatory Environment

The regulatory environment for opioids, including DURAGESIC, has become increasingly stringent due to concerns about addiction, abuse, and overdose. The FDA has implemented a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of opioid analgesics outweigh the risks. This includes assessing patients' risk before prescribing and monitoring them regularly for signs of addiction or misuse[4].

Financial Trajectory

Historical Context

In the early 2000s, the opioid market, including prescription opioids like OxyContin, experienced significant growth. However, this growth was often driven by aggressive marketing strategies that downplayed the risks of addiction and overdose. For instance, Purdue Pharma, with the help of McKinsey, implemented strategies like "Project Turbocharge" to boost sales of OxyContin, despite knowing the high risks associated with these drugs[3].

Current Market

The financial trajectory of DURAGESIC has been influenced by the broader opioid crisis. While DURAGESIC itself is not as widely abused as some other opioids, its sales have been impacted by the overall decline in prescription opioid use due to increased regulatory scrutiny and public awareness of opioid risks.

Revenue and Sales

Despite the challenges, DURAGESIC remains a significant player in the opioid market. The revenue generated from DURAGESIC is substantial, although exact figures are not publicly disclosed. The cost-effectiveness of DURAGESIC, particularly for patients who require long-term pain management, contributes to its continued use.

Cost and Pricing

The cost of DURAGESIC can vary based on the strength of the patch and the patient's insurance coverage. For example, a single patch can range from several dollars to over $100, depending on the dosage and the pharmacy. The high cost is partly due to the potency and the controlled nature of the drug[4].

Illicit Market Impact

The illicit fentanyl market has also had an indirect impact on the prescription opioid market, including DURAGESIC. Illicitly manufactured fentanyl and its analogues have led to a significant increase in overdose deaths and have further heightened regulatory and public scrutiny of all opioids. This increased scrutiny has led to stricter prescribing guidelines and monitoring, which can affect the sales and revenue of prescription opioids like DURAGESIC[1].

Competitive Landscape

The competitive landscape for opioid analgesics is complex, with various prescription and non-prescription alternatives available. DURAGESIC competes with other transdermal patches, oral opioids, and non-opioid analgesics. The market is highly regulated, and any new entrants must navigate stringent FDA approval processes and REMS requirements[4].

Future Outlook

The future outlook for DURAGESIC is influenced by several factors:

• Regulatory Changes: Continued regulatory scrutiny and potential changes in prescribing guidelines could impact sales.
• Public Health Initiatives: Efforts to combat the opioid epidemic may lead to reduced prescription rates.
• Alternative Treatments: The development of non-opioid pain management options could reduce demand for opioids like DURAGESIC.
• Safer Supply Programs: Initiatives aimed at reducing overdose risks, such as safer supply programs for fentanyl patches, may also influence the market dynamics[5].

Key Takeaways

• DURAGESIC is a potent opioid analgesic used for severe, chronic pain management in opioid-tolerant patients.
• The market is heavily regulated due to concerns about addiction, abuse, and overdose.
• The financial trajectory is influenced by broader opioid market trends and regulatory changes.
• The illicit fentanyl market has indirectly impacted the prescription opioid market.
• The future outlook is uncertain due to ongoing regulatory and public health initiatives.

FAQs

What is DURAGESIC used for?

DURAGESIC is used for the management of severe, chronic pain in opioid-tolerant patients who require daily, around-the-clock, long-term opioid treatment.

What are the risks associated with DURAGESIC?

DURAGESIC carries risks of addiction, abuse, and misuse, which can lead to overdose and death. It also poses risks of respiratory depression, especially in children and individuals with certain medical conditions.

How is DURAGESIC regulated?

DURAGESIC is regulated under the FDA's Risk Evaluation and Mitigation Strategy (REMS) to ensure that its benefits outweigh the risks. This includes strict prescribing guidelines and patient monitoring.

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

The illicit fentanyl market has increased regulatory scrutiny and public awareness of opioid risks, indirectly affecting the sales and revenue of prescription opioids like DURAGESIC.

What are the future prospects for DURAGESIC?

The future prospects for DURAGESIC are influenced by regulatory changes, public health initiatives, and the development of alternative pain management treatments.

Sources

1. U.S. Sentencing Commission: Fentanyl Analogues - U.S. Sentencing Commission.
2. JAMA Network Open: Buprenorphine Dose and Time to Discontinuation Among Patients with Opioid Use Disorder.
3. City of Seattle: Complaint against McKinsey & Company.
4. FDA: Duragesic - Full Prescribing Information.
5. ScienceDirect: A qualitative evaluation of a fentanyl patch safer supply program in reducing risk of overdose.