FENTANYL-25 Drug Patent Profile

Which patents cover Fentanyl-25, and when can generic versions of Fentanyl-25 launch?

Fentanyl-25 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-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 FENTANYL-25

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	2,594
DailyMed Link:	FENTANYL-25 at DailyMed

Recent Clinical Trials for FENTANYL-25

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-25 clinical trials

Pharmacology for FENTANYL-25

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-25

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-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-001	Aug 20, 2007		DISCN	No	No
Noven	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-001	Oct 16, 2009		DISCN	No	No
Lavipharm Labs	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077051-001	Aug 4, 2006		DISCN	No	No

EU/EMA Drug Approvals for FENTANYL-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

FENTANYL-25 Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a highly potent synthetic opioid, has significantly altered the global illicit drug market landscape. Its impact is felt across various regions, from North America to Europe and Asia, and its financial trajectory is intertwined with the complexities of international crime and public health crises.

Global Availability and Distribution

Fentanyl is widely available on darknet markets, where online vendors utilize postal services to distribute small quantities of the drug. These markets, such as Dream, Empire, and Wall Street, have been instrumental in the global distribution of fentanyl and its analogues[1].

Economic Impact on Traditional Opiate Markets

The rise of fentanyl has led to a displacement of traditional heroin markets, particularly in North America. Fentanyl's low production costs and high potency make it an attractive alternative for drug producers and marketers. This shift has resulted in a drop in opium production and farm gate prices in Mexico, a primary source of heroin for the U.S.[3].

Financial Aspects of Fentanyl Trade

Production and Pricing

Fentanyl is produced at a fraction of the cost of heroin. For instance, the wholesale price of fentanyl, adjusted for potency, is estimated to be about 1% of that of heroin. This makes fentanyl a highly lucrative option for drug traffickers. Ten grams of fentanyl purchased on the darknet for approximately $1,000 can produce the equivalent of one kilogram of synthetic heroin, valued at between $160,000 and $195,000 in the Australian illicit market[1][3].

Revenue and Profit Margins

The synthetic opioid trade, including fentanyl, generates revenues worth tens of billions of dollars annually. The high profit margins are due to the drug's potency and the low cost of production. For example, a mere 16.8 milligrams of fentanyl can produce 5.5 grams of heroin equivalent, significantly amplifying the financial returns[1].

Role of Darknet Markets

Darknet markets play a crucial role in the distribution of fentanyl. These platforms provide anonymity and efficiency, allowing vendors to list products with detailed descriptions, quantities, and prices. Administrators of these markets typically receive a commission of between 3% and 8% from each sale and offer escrow services to facilitate transactions[1].

Transnational Organized Crime

Transnational organized crime groups, particularly those from China and South America, dominate the supply of fentanyl and other synthetic opioids. These groups have adapted to the opportunities offered by darknet markets and global shipping networks. The efficiency and anonymity of these digital markets have combined with a well-organized trans-Pacific contraband trade, facilitating the global supply of cheaper synthetic opioids[1].

Law Enforcement and Regulatory Efforts

Counter-Fentanyl Strike Force

The U.S. Department of the Treasury has launched a Counter-Fentanyl Strike Force to target the global illicit supply chain of fentanyl. This initiative leverages Treasury's expertise in identifying and countering financial crimes, including sanctions and joint investigations with international partners. The Strike Force aims to disrupt the financial networks of transnational criminal organizations involved in fentanyl trafficking[2].

Financial Intelligence and Sanctions

Efforts to combat fentanyl trafficking include using financial intelligence to map the financial networks of criminal organizations and imposing sanctions on individuals and entities involved in the illicit trade. Since 2021, the U.S. Treasury has imposed nearly 250 sanctions on those involved in the global illicit drug trade, with a focus on the fentanyl supply chain[2].

International Cooperation

International cooperation is crucial in addressing the fentanyl crisis. Organizations like the Financial Action Task Force (FATF) work to strengthen international standards to counter money laundering and help global partners identify typologies and trends related to synthetic opioid trafficking[5].

Public Health Implications

Overdose Mortality

The rapid spread of fentanyl in unregulated drug markets has significantly increased overdose mortality rates. Between 2014 and 2021, the overdose fatality rate involving synthetic opioids other than methadone increased by 1200% in the U.S.[4].

Geographic Spread

Fentanyl's spread across the U.S. has been uneven, with earlier changepoints observed in eastern states and a gradual westward spread over several years. This heterogenous spread complicates the assessment of interventions aimed at reducing overdose mortality[4].

Economic and Political Impacts

Impact on Afghanistan

The rise of fentanyl could potentially disrupt Afghanistan's opiate industry, which is a significant component of the country's economy. A collapse in demand for Afghan opiates could have profound implications for rural households, local powerbrokers, and the stability of the government in Kabul[3].

Global Market Segmentation

The global heroin market remains segmented, with different regions sourcing opiates from various suppliers. While fentanyl has displaced heroin in some North American markets, Europe and Asia have been less affected so far. However, the potential for fentanyl to gain traction in these regions is significant[3].

Key Takeaways

• Global Distribution: Fentanyl is widely available on darknet markets and distributed through postal services.
• Economic Displacement: Fentanyl has displaced traditional heroin markets, particularly in North America, due to its low production costs and high potency.
• Financial Aspects: The fentanyl trade generates tens of billions of dollars annually, with high profit margins due to its potency and low production costs.
• Law Enforcement: Efforts include the launch of a Counter-Fentanyl Strike Force, use of financial intelligence, and international cooperation to disrupt the illicit supply chain.
• Public Health: The spread of fentanyl has significantly increased overdose mortality rates, with a heterogenous spread across different regions.
• Economic and Political Impacts: The rise of fentanyl could disrupt Afghanistan's opiate industry and have broader economic and political implications globally.

FAQs

Q: How is fentanyl distributed globally?

Fentanyl is distributed globally through darknet markets, where vendors use postal services to ship small quantities of the drug.

Q: What is the economic impact of fentanyl on traditional heroin markets?

Fentanyl has displaced traditional heroin markets, particularly in North America, due to its low production costs and high potency, leading to a drop in opium production and farm gate prices in Mexico.

Q: How does the U.S. Treasury combat fentanyl trafficking?

The U.S. Treasury has launched a Counter-Fentanyl Strike Force to target the global illicit supply chain of fentanyl, using financial intelligence, sanctions, and international cooperation.

Q: What are the public health implications of fentanyl's spread?

The spread of fentanyl has significantly increased overdose mortality rates, with a 1200% increase in overdose fatalities involving synthetic opioids other than methadone between 2014 and 2021 in the U.S.

Q: How might the rise of fentanyl affect Afghanistan's economy?

The rise of fentanyl could potentially disrupt Afghanistan's opiate industry, leading to significant economic and political implications, including a humanitarian crisis that could threaten the stability of the government in Kabul.

Sources

1. Australian Institute of Criminology. Fentanyl availability on darknet markets. February 2020.
2. U.S. Department of the Treasury. U.S. Treasury Launches Counter-Fentanyl Strike Force. December 4, 2023.
3. RAND Corporation. Afghanistan in the Era of Fentanyl. July 2021.
4. JAMA Network Open. Drug Decriminalization, Fentanyl, and Fatal Overdoses in Oregon. September 5, 2024.
5. Financial Action Task Force (FATF). Money Laundering from Fentanyl and Synthetic Opioids. 2022.