DURAGESIC-37 Drug Patent Profile

Which patents cover Duragesic-37, and what generic alternatives are available?

Duragesic-37 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-37 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-37

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	26
Patent Applications:	4,386
DailyMed Link:	DURAGESIC-37 at DailyMed

Recent Clinical Trials for DURAGESIC-37

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-37 clinical trials

US Patents and Regulatory Information for DURAGESIC-37

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-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-006	Jan 24, 2018		DISCN	Yes	No

EU/EMA Drug Approvals for DURAGESIC-37

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
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
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

International Patents for DURAGESIC-37

See the table below for patents covering DURAGESIC-37 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8707667
Spain	557179
Belgium	905568
United Kingdom	8514445
Spain	545366
Japan	S6137725	SKIN ADMINISTRATION OF FENTANYL AND DEVICE

Supplementary Protection Certificates for DURAGESIC-37

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
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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

DURAGESIC-37 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of DURAGESIC and Similar Fentanyl Products

Introduction

DURAGESIC, a transdermal fentanyl patch, is a potent opioid medication used to manage severe chronic pain in patients who are already tolerant to opioid therapy. Understanding the market dynamics and financial trajectory of DURAGESIC and similar fentanyl products is crucial, especially given the complex and often illicit nature of the opioid market.

Market Overview of Fentanyl Products

Legitimate Market

In the legitimate pharmaceutical market, DURAGESIC and other fentanyl products are prescribed for severe pain management. These products are highly regulated and monitored due to their potency and potential for abuse. The legitimate market is characterized by strict prescribing guidelines, patient monitoring, and controlled distribution channels.

Illicit Market

The illicit market for fentanyl and its analogues is a significant concern. Fentanyl is often manufactured illegally and distributed through darknet markets, online vendors, and other clandestine channels. This market is driven by high demand, particularly in regions where opioid use is prevalent, such as North America[1][3].

Availability and Pricing

Legitimate Channels

In legitimate channels, the pricing of DURAGESIC is determined by pharmaceutical companies, insurance coverage, and government regulations. For instance, in 2019, pharmaceutical companies continued to invest in research and development, including innovations in pain management, which can influence the pricing and availability of such medications[2].

Illicit Channels

On the darknet and other illicit markets, fentanyl products, including those mimicking DURAGESIC, are sold at significantly lower costs compared to their legitimate counterparts. For example, ten grams of fentanyl purchased on the darknet can produce the equivalent of one kilogram of synthetic heroin, valued at between A$160,000 and A$195,000 in the Australian illicit market[1].

Demand Dynamics

Medical Demand

The demand for DURAGESIC and similar fentanyl products in the medical sector is driven by the need for effective pain management. Patients with severe chronic pain who are opioid-tolerant rely on these medications. However, access to these medications is often limited by strict prescribing guidelines and regulatory controls.

Illicit Demand

The illicit demand for fentanyl is fueled by the opioid crisis, particularly in regions like North America. The COVID-19 pandemic has exacerbated this issue, with more people turning to illicit substances due to increased poverty, unemployment, and social inequalities[3].

Financial Trajectory

Pharmaceutical Industry

For pharmaceutical companies, the financial trajectory of fentanyl products like DURAGESIC is influenced by several factors, including research and development costs, regulatory approvals, and market competition. Companies like Johnson & Johnson, which have a portfolio of pharmaceutical and medical devices, continue to invest in innovation and expansion, which can drive revenue growth[2].

Illicit Market Financials

The financials of the illicit fentanyl market are difficult to quantify due to its clandestine nature. However, it is estimated that major drug markets on the dark web are worth hundreds of millions of dollars annually. For instance, the global illicit drug trade, including fentanyl, continues to thrive despite regulatory efforts, with online sales and contactless transactions becoming more prevalent[3].

Regulatory Environment

Legitimate Market Regulations

The legitimate market for fentanyl products is heavily regulated. Governments and health organizations implement strict controls on prescribing, distribution, and patient monitoring to mitigate the risk of abuse and overdose. Regulatory enforcement can impact the financial trajectory by affecting production costs, distribution channels, and patient access[1][3].

Illicit Market Regulations

Regulatory efforts to combat the illicit fentanyl market include international cooperation, law enforcement actions, and public health initiatives. However, these efforts often face challenges due to the adaptability of illicit drug traffickers and the global reach of darknet markets[1][3].

Impact on Public Health

Overdose Risks

The presence of fentanyl in the illicit drug supply significantly increases the risk of overdose deaths. According to the CDC, overdose deaths involving illegally manufactured fentanyls (IMFs) have been stable at high levels in many regions, highlighting the need for robust public health measures to address this crisis[4].

Harm Reduction and Treatment

There is a growing need for harm reduction strategies and access to controlled medicines for pain management. The demand for opioid agonists like methadone and buprenorphine, as well as naloxone for overdose reversal, indicates a user demand for self-medicated recovery and harm reduction[1].

Economic and Social Implications

Economic Impact

The illicit drug trade, including fentanyl, hampers economic and social development, particularly in vulnerable communities. The COVID-19 pandemic has exacerbated these issues, pushing more people into poverty and increasing susceptibility to drug use[3].

Social Impact

The social impact of the fentanyl crisis is profound, with significant disparities in access to essential controlled medicines. In regions like West and Central Africa, access to pain medication is severely limited, while in North America, the opioid crisis continues to devastate communities[3].

Key Takeaways

• Legitimate vs. Illicit Markets: DURAGESIC and similar fentanyl products have distinct market dynamics in legitimate and illicit channels, with the latter driven by high demand and low costs.
• Regulatory Challenges: Strict regulations in the legitimate market contrast with the adaptive and clandestine nature of the illicit market.
• Public Health Impact: The presence of fentanyl in the illicit drug supply significantly increases overdose risks, necessitating robust public health measures.
• Economic and Social Implications: The fentanyl crisis affects economic and social development, particularly in vulnerable communities.

FAQs

What is the primary use of DURAGESIC in the medical field?

DURAGESIC is used to manage severe chronic pain in patients who are already tolerant to opioid therapy.

How does the illicit market affect the availability of fentanyl products?

The illicit market significantly increases the availability of fentanyl products, often at lower costs, through darknet markets and other clandestine channels.

What are the public health implications of the fentanyl crisis?

The fentanyl crisis significantly increases the risk of overdose deaths and necessitates robust public health measures, including harm reduction strategies and access to controlled medicines.

How has the COVID-19 pandemic impacted the opioid crisis?

The COVID-19 pandemic has exacerbated the opioid crisis by pushing more people into poverty, increasing unemployment, and making more people susceptible to drug use.

What are the economic implications of the illicit fentanyl market?

The illicit fentanyl market hampers economic and social development, particularly in vulnerable communities, by increasing poverty and social inequalities.

Sources

1. Australian Institute of Criminology - Fentanyl availability on darknet markets
2. Johnson & Johnson - 2019 Annual Report
3. UN Office on Drugs and Crime - World Drug Report 2021
4. CDC - Detection of Illegally Manufactured Fentanyls and Carfentanil