FENTANYL-12 Drug Patent Profile

When do Fentanyl-12 patents expire, and what generic alternatives are available?

Fentanyl-12 is a drug marketed by Difgen Pharms, Kindeva, Mylan Technologies, Specgx Llc, and Zydus Pharms. and is included in five NDAs.

The generic ingredient in FENTANYL-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 FENTANYL-12

US Patents:	0
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	4,390
DailyMed Link:	FENTANYL-12 at DailyMed

Recent Clinical Trials for FENTANYL-12

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-12 clinical trials

Pharmacology for FENTANYL-12

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-12

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Difgen Pharms	FENTANYL-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-005	Sep 11, 2015	AB	RX	No	No
Specgx Llc	FENTANYL-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-005	Jun 11, 2015	AB	RX	No	No
Kindeva	FENTANYL-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	202097-001	Nov 4, 2016	AB	RX	No	No
Mylan Technologies	FENTANYL-12	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-005	Jan 23, 2007	AB	RX	No	No

EU/EMA Drug Approvals for FENTANYL-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
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-12 Market Analysis and Financial Projection Experimental

The Rise and Impact of Fentanyl: Understanding Market Dynamics and Financial Trajectories

Introduction

Fentanyl, a synthetic opioid significantly more potent than heroin, has revolutionized the illicit drug market globally, particularly in North America. This article delves into the market dynamics, financial aspects, and the broader implications of the fentanyl trade.

The Emergence of Fentanyl in Illicit Markets

Fentanyl has become a dominant force in the opioid crisis, replacing heroin in many markets due to its potency and cost-effectiveness. It is often mixed with other drugs like cocaine and methamphetamine, exacerbating the overdose risk[3].

Market Saturation and User Preferences

Fentanyl has saturated many U.S. drug markets, serving as a cheaper and more potent alternative to heroin. Users are drawn to its intense "rush" and its ability to overcome heroin tolerance, despite the heightened risk of overdose[1][3].

Global Supply Chains

The supply of fentanyl is heavily influenced by international networks. Precursor chemicals are often sourced from China and India, then shipped to Mexico, where they are used to manufacture fentanyl. This trans-Pacific contraband trade is dominated by Chinese and South American crime groups, who have adapted to the opportunities offered by darknet markets[1].

Darknet Markets and Online Distribution

Fentanyl and its analogues are widely available on darknet markets, where vendors use postal services to distribute small quantities. These markets provide a platform for the rapid adoption and distribution of new synthetic opioids, exploiting the anonymity and efficiency of the illicit digital economy[1][4].

Financial Aspects of Fentanyl Trafficking

Revenue Generation

A single kilogram of fentanyl can generate significant revenue. Purchased for $3,000 to $5,200, it can be pressed into pills containing 1.5 milligrams of fentanyl, sold for $10 each, resulting in approximately $6.6 million in revenue[4].

Money Laundering Mechanisms

Fentanyl traffickers use sophisticated money laundering techniques, including cross-border transactions, money brokers, and cash couriers. They often utilize Asian money laundering organizations and the "shadow banking" system to circumvent currency controls. Cryptocurrencies are also used, but primarily for converting to fiat currency or purchasing precursor chemicals[5].

Financial Networks and Sanctions

The U.S. Treasury has targeted the financial networks of fentanyl traffickers, including the Sinaloa Cartel, by imposing sanctions and disrupting their access to the U.S. financial system. This approach aims to cut off the drug cartels' ability to profit from their activities[2].

Impact on Traditional Drug Markets

The rise of fentanyl has significantly impacted traditional drug markets. Heroin production in Mexico has declined in value due to the increased availability of cheaper, fentanyl-laced heroin. Additionally, the decline in cocaine use in the U.S. is partly attributed to the falling price and increased potency of methamphetamine[3].

Regulatory Challenges

Regulating fentanyl is challenging due to its chemical versatility. Producers modify fentanyl's basic chemical structure to create new analogues, which can be sold before they are scheduled as controlled substances. This constant evolution makes it difficult for law enforcement to keep pace[4].

Public Health Crisis

The fentanyl epidemic has led to a significant increase in overdose deaths. Since 2015, fentanyl-related deaths have increased by almost 5,000 percent in the U.S. The potency of fentanyl, approximately 30 times that of heroin, amplifies the risk of death or serious injury[2][4].

User Demand and Harm Reduction

Despite the risks, there is a notable demand for fentanyl among users seeking a more potent opioid. There is also evidence of user demand for harm reduction measures, such as methadone, buprenorphine, and naloxone, indicating a need for self-medicated recovery options[1].

Law Enforcement and Policy Responses

Law enforcement agencies and regulatory bodies are working to disrupt fentanyl distribution networks. This includes targeting financial networks, imposing sanctions, and increasing international legal attention to precursor chemicals. The Financial Action Task Force (FATF) has issued recommendations to counter the financial flows from the illicit fentanyl trade[2][5].

Case Studies and Enforcement Actions

Case studies highlight the complexity of fentanyl trafficking. For example, a case involving Chinese nationals operating as money brokers in Mexico illustrates the transnational nature of these operations. Enforcement actions, such as the arrest of key figures and the disruption of financial transactions, are critical in combating these networks[5].

Recommendations for Counteracting Fentanyl Trade

The FATF report recommends several steps to counter the fentanyl trade, including increased scrutiny of financial transactions, enhanced international cooperation, and the use of professional money laundering networks to identify and disrupt illicit financial flows[5].

Conclusion

The fentanyl trade represents a complex and highly lucrative segment of the illicit drug market, driven by its potency, cost-effectiveness, and the adaptability of its producers and distributors. Understanding the market dynamics and financial trajectories of fentanyl is crucial for developing effective strategies to combat this public health crisis.

Key Takeaways

• Potency and Cost-Effectiveness: Fentanyl is significantly more potent and cheaper than heroin, making it a preferred choice for many users.
• Global Supply Chains: Fentanyl production involves international networks, with precursor chemicals sourced from China and India.
• Darknet Markets: These platforms play a critical role in the distribution of fentanyl and its analogues.
• Financial Mechanisms: Traffickers use sophisticated money laundering techniques, including cross-border transactions and cryptocurrencies.
• Public Health Impact: Fentanyl has led to a significant increase in overdose deaths and continues to pose a major public health risk.
• Regulatory Challenges: The constant evolution of fentanyl analogues makes regulation challenging.

FAQs

Q: How potent is fentanyl compared to heroin? A: Fentanyl is approximately 30 times more potent than heroin[4].

Q: What role do darknet markets play in the distribution of fentanyl? A: Darknet markets provide a platform for the rapid adoption and distribution of fentanyl and its analogues, exploiting the anonymity and efficiency of the illicit digital economy[1][4].

Q: How do fentanyl traffickers launder their money? A: Traffickers use cross-border transactions, money brokers, cash couriers, and professional money laundering networks, often involving Asian money laundering organizations and the "shadow banking" system[5].

Q: What are the public health implications of the fentanyl epidemic? A: The fentanyl epidemic has led to a significant increase in overdose deaths, with fentanyl-related deaths increasing by almost 5,000 percent since 2015 in the U.S.[2].

Q: How are regulatory bodies responding to the fentanyl crisis? A: Regulatory bodies are targeting financial networks, imposing sanctions, and increasing international legal attention to precursor chemicals to disrupt fentanyl distribution networks[2][5].

Sources

1. Australian Institute of Criminology - Fentanyl availability on darknet markets[1].
2. U.S. Department of the Treasury - Remarks by Deputy Secretary of the Treasury Wally Adeyemo[2].
3. Brookings Institution - The dynamics of US drug markets[3].
4. U.S. Sentencing Commission - Fentanyl Analogues[4].
5. Money Laundering News - Countering Financial Flows From the Illicit Trade in Fentanyl and Synthetic Opioids[5].