FENTANYL-50 Drug Patent Profile

When do Fentanyl-50 patents expire, and when can generic versions of Fentanyl-50 launch?

Fentanyl-50 is a drug marketed by Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms. and is included in nine NDAs.

The generic ingredient in FENTANYL-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 FENTANYL-50

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	1,950
DailyMed Link:	FENTANYL-50 at DailyMed

Recent Clinical Trials for FENTANYL-50

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Merck Sharp & Dohme LLC	N/A
University Hospital "Sestre Milosrdnice"	N/A

See all FENTANYL-50 clinical trials

Pharmacology for FENTANYL-50

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Ut Inc	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-002	Aug 20, 2007		DISCN	No	No
Noven	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-002	Oct 16, 2009		DISCN	No	No
Lavipharm Labs	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077051-002	Aug 4, 2006		DISCN	No	No
Specgx Llc	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-002	Feb 9, 2011	AB	RX	No	No

EU/EMA Drug Approvals for FENTANYL-50

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

FENTANYL-50 Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a synthetic opioid 50 to 100 times more potent than morphine, has become a pivotal player in the global illicit drug market. Its impact is felt across various sectors, from public health to international trade and finance. This article delves into the market dynamics and financial trajectory of fentanyl, exploring its production, distribution, economic implications, and the challenges it poses.

Production and Supply Chain

Origins and Manufacturing

Fentanyl was first synthesized in 1959 as a medical painkiller, but its illicit production has surged in recent years. Initially, much of the fentanyl entering the U.S. market was manufactured in China and then transshipped through Mexico. However, by around 2019, Mexico had become the primary source of U.S.-bound illicit fentanyl and its analogues[2][3].

Cost of Production

The production cost of fentanyl is relatively low, estimated at around $1,000 per kilogram. This low cost, combined with its high potency and ease of synthesis, makes fentanyl a highly profitable drug for criminal organizations[5].

Market Dynamics

Supply-Led Market

Current evidence suggests that the introduction of fentanyl into the drug market is largely supply-led. Heroin supply shocks and shortages, along with the lower production costs and risks associated with fentanyl, have driven suppliers to substitute or adulterate heroin with fentanyl[1].

Demand and User Preferences

While some users can identify and even desire fentanyl for its strong, fast-acting effects, the majority lack concrete knowledge of its presence in the drugs they purchase. This lack of information and choice makes it difficult for users to express their demand effectively[1].

Role of Dark Web and Cryptomarkets

Cryptomarkets on the dark web offer buyers greater information and competition compared to offline markets. However, these markets are not without their challenges, including access barriers and significant health consequences associated with fentanyl use. Despite these issues, darknet markets remain a significant avenue for the distribution of synthetic opioids like fentanyl[4].

Financial Trajectory

Profitability

Fentanyl's high street value, ranging from $50,000 to $110,000 per kilogram, makes it an extremely profitable drug for criminal organizations. This profitability is further enhanced by its ease of mixing with other substances, such as heroin and cocaine, which can increase their potency and addictive potential[5].

Money Laundering and Financial Flows

Opioid-related financial flows involve various methods, including financial transfers through banks and money services businesses, cryptocurrencies, and traditional money laundering techniques like bulk cash smuggling and trade-based money laundering (TBML). Mexican transnational criminal organizations (TCOs) often collaborate with Chinese money laundering organizations to repatriate drug proceeds back into the Mexican banking system[2].

Economic Impact

The opioid crisis, driven significantly by fentanyl, has had a staggering economic impact. In 2020, the economic cost of the opioid crisis in the United States was estimated at $1.5 trillion, including costs related to treatment, prevention, and law enforcement[5].

Distribution and Trafficking

Regional Impact

Initially, the fentanyl problem was regional, affecting areas such as the industrial Midwest, Appalachia, the Mid-Atlantic, and New England. However, the issue has since expanded, with fentanyl now being a national and international concern[3].

Seizures and Law Enforcement Efforts

Significant seizures of fentanyl have been reported, highlighting the scale of the problem. For example, in August 2019, a massive 23,368-kilogram shipment of fentanyl was seized by Mexican authorities, indicating the large volumes involved in fentanyl trafficking[4].

Challenges in Regulation

Chemical Variability

Fentanyl's ease of modification has led to the production of numerous analogs, over 1,400 of which have been reported. This chemical variability makes it challenging for law enforcement to keep up with the latest trends in fentanyl production and to develop effective detection and regulation strategies[5].

Health Consequences

The high potency of fentanyl and its analogs has led to a significant increase in overdose deaths. Fentanyl is now the leading cause of drug-related fatalities in the United States, with its involvement in more youth drug deaths than heroin, methamphetamine, cocaine, benzodiazepines, and prescription drugs combined[5].

International Cooperation and Policy Responses

U.S.-Mexico Cooperation

The U.S. government has taken unilateral and bilateral actions to address Mexico's role in fentanyl production and trafficking. This includes sanctions against Mexico-based individuals involved in fentanyl trafficking and cooperation under the Bicentennial Framework for U.S.-Mexican security cooperation[2].

Legislative and Law Enforcement Actions

Congress has been involved in legislative activities to oversee and implement efforts to combat fentanyl trafficking. The Department of Justice has also indicted key figures in Mexican TCOs for their roles in fentanyl trafficking[2].

Future Directions and Solutions

Scientific Advances

Advances in pain relief research could help reduce future deaths by developing safer opioids that minimize the risk of respiratory depression. Understanding the binding pockets and structural information of opioid receptors may enable the development of safer opioids with reduced side effects[5].

Public Health Strategies

Addressing the fentanyl crisis requires comprehensive public health strategies, including improved treatment options, enhanced surveillance, and education campaigns to raise awareness about the dangers of fentanyl.

Key Takeaways

• Supply-Led Market: Fentanyl's introduction into the drug market is largely driven by supply factors, including heroin shortages and lower production costs.
• High Profitability: Fentanyl's low production cost and high street value make it highly profitable for criminal organizations.
• Complex Distribution: Fentanyl is distributed through various channels, including dark web markets and traditional trafficking routes.
• Significant Health Impact: Fentanyl is the leading cause of drug-related fatalities in the U.S., with severe health consequences.
• International Cooperation: Addressing fentanyl trafficking requires international cooperation, particularly between the U.S. and Mexico.

FAQs

Q: What is the primary source of fentanyl entering the U.S. market?

A: As of around 2019, Mexico has replaced China as the primary source of U.S.-bound illicit fentanyl and its analogues[2].

Q: Why is fentanyl so profitable for criminal organizations?

A: Fentanyl is highly profitable due to its low production cost (around $1,000 per kilogram) and high street value (ranging from $50,000 to $110,000 per kilogram)[5].

Q: How does fentanyl affect the heroin market?

A: Fentanyl often substitutes or adulterates heroin, increasing the risk of overdose deaths and reducing the value of opium production in Mexico[4].

Q: What role do dark web markets play in fentanyl distribution?

A: Dark web markets provide an avenue for distributing synthetic opioids like fentanyl, offering buyers greater information and competition compared to offline markets[4].

Q: What are the economic costs associated with the fentanyl crisis?

A: The economic cost of the opioid crisis, driven significantly by fentanyl, was estimated at $1.5 trillion in 2020, including costs related to treatment, prevention, and law enforcement[5].

Sources

1. Illicit fentanyls in the opioid street market: desired or imposed? - PubMed
2. Illicit Fentanyl and Mexico's Role - CRS Reports
3. The Future of Fentanyl Dynamics in Supply, Uses, and Consequences - YouTube
4. Fentanyl availability on darknet markets - Australian Institute of Criminology
5. Advancing progress in the fight against fentanyl - CAS.org