FENTANYL-75 Drug Patent Profile

Which patents cover Fentanyl-75, and when can generic versions of Fentanyl-75 launch?

Fentanyl-75 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-75 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-75

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	2,596
DailyMed Link:	FENTANYL-75 at DailyMed

Recent Clinical Trials for FENTANYL-75

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-75 clinical trials

Pharmacology for FENTANYL-75

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-75

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-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-003	Aug 20, 2007		DISCN	No	No
Noven	FENTANYL-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-003	Oct 16, 2009		DISCN	No	No
Lavipharm Labs	FENTANYL-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077051-003	Aug 4, 2006		DISCN	No	No

EU/EMA Drug Approvals for FENTANYL-75

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-75 Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a highly potent synthetic opioid, has significantly impacted global drug markets, particularly in North America. This article delves into the market dynamics and financial aspects of fentanyl, highlighting its availability, distribution, and the economic implications of its presence in the illicit drug market.

Fentanyl's Entry into Illicit Drug Markets

Fentanyl has become a dominant force in the opioid epidemic, particularly since its introduction into the heroin market in the early 2010s. Initially used as an adulterant in or replacement for white powder heroin, fentanyl and its analogs have spread rapidly across the United States and other regions[3][4].

Availability and Distribution

Fentanyl is widely available on darknet markets, where online vendors use postal services to distribute small quantities. This method of distribution leverages the efficiency and anonymity of the illicit digital economy, making it challenging to regulate[1].

Darknet Markets

Darknet markets such as Berlusconi, Dream, and Empire have been identified as significant avenues for fentanyl distribution. Although the number of fentanyl listings is relatively small compared to other drugs, the potency of fentanyl amplifies its impact. For instance, 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].

Trans-Pacific Contraband Trade

The supply chain of fentanyl involves precursor chemicals diverted or clandestinely manufactured in China and India, then shipped into North America via Mexico. Chinese and South American crime groups dominate this lucrative trade, adapting to the opportunities offered by darknet markets[1].

Economic Implications

The financial trajectory of fentanyl is marked by its high profitability and the significant economic impact on the drug market.

Revenue Generation

Criminal organizations can generate substantial revenue from fentanyl. For example, one kilogram of fentanyl can produce approximately 1 million counterfeit pills, resulting in potentially $10-20 million in revenue. This makes fentanyl a highly lucrative option compared to traditional opioids[1].

Market Value

In Australia, a mere 16.8 milligrams of fentanyl extracted from a 100-microgram transdermal patch can produce 5.5 grams of heroin equivalent, valued between A$1,100 and A$3,850. This highlights the high value and potency of fentanyl in the illicit market[1].

Impact on Traditional Opioids

The introduction of fentanyl has reduced the value of opium production in Mexico and increased the risk of overdose deaths. Consumers in some areas are seeking fentanyl over heroin due to its greater "rush" and potency in overcoming heroin tolerance[1].

Public Health Implications

The proliferation of fentanyl has severe public health implications, particularly in terms of overdose deaths.

Overdose Deaths

According to the CDC, more than 107,000 Americans died from drug overdoses in the 12 months ending in January 2022, with 71,450 of these deaths involving synthetic opioids, primarily fentanyl and its analogs[3].

Enhanced Surveillance

The rapid expansion of the heroin and fentanyl market necessitates enhanced, timely surveillance of the illicit drug supply and opioid overdoses. Comprehensive testing of opioid overdose deaths is critical to track and respond to changes in the illicit opioid market, including the introduction of fentanyl analogs[4].

User Demand and Harm Reduction

Despite the risks, there is a notable demand for fentanyl among some users due to its potency and the "rush" it provides.

User Perspectives

Heroin users have expressed mixed views about fentanyl, including concerns about its overdose risk and short duration but also its potency in overcoming heroin tolerance. This dual perspective highlights the complex nature of fentanyl use[1].

Harm Reduction

The presence of opioid agonists such as methadone, buprenorphine, and naloxone in darknet markets suggests user demand for harm reduction and self-medicated recovery. This indicates a need for comprehensive harm reduction strategies to address the opioid epidemic[1].

Global Reach and Adaptation

Fentanyl's impact is not limited to North America; it has a global reach, particularly through the adaptation of crime groups to new market opportunities.

Transnational Crime

Chinese and South American crime groups have adapted to the opportunities offered by darknet markets, dominating the supply of illicit products. This transnational contraband trade has significant implications for global drug policy and law enforcement[1].

Regulatory Challenges

Regulating the manufacture and distribution of fentanyl is challenging due to its clandestine production and distribution methods.

Anonymity and Efficiency

The efficiency and anonymity of the illicit digital economy make it difficult to track and regulate fentanyl production and distribution. Precursor chemicals are often diverted or clandestinely manufactured, further complicating regulatory efforts[1].

Financial Impact on Law Enforcement and Public Health

The financial burden of addressing the fentanyl crisis is substantial, impacting both law enforcement and public health resources.

Budgetary Allocations

Significant budgetary allocations are required to combat the fentanyl epidemic. For instance, the U.S. government allocates substantial funds for diplomatic engagement, foreign assistance, and domestic programs aimed at addressing drug trafficking and public health crises[2].

Key Takeaways

• High Potency and Profitability: Fentanyl is highly potent and lucrative, making it a significant player in the illicit drug market.
• Global Distribution: Fentanyl is distributed globally through darknet markets and trans-Pacific contraband trade.
• Public Health Crisis: The proliferation of fentanyl has led to a significant increase in overdose deaths and public health challenges.
• Regulatory Challenges: The clandestine nature of fentanyl production and distribution poses significant regulatory challenges.
• Economic Impact: Fentanyl has disrupted traditional opioid markets and generated substantial revenue for criminal organizations.

FAQs

Q: How is fentanyl distributed in the illicit market?

A: Fentanyl is distributed through darknet markets, where online vendors use postal services to deliver small quantities. It is also part of a trans-Pacific contraband trade involving precursor chemicals from China and India.

Q: What is the economic impact of fentanyl on the drug market?

A: Fentanyl has significantly impacted the drug market by reducing the value of opium production and generating substantial revenue for criminal organizations. One kilogram of fentanyl can produce approximately 1 million counterfeit pills, resulting in potentially $10-20 million in revenue.

Q: Why is fentanyl attractive to some drug users?

A: Fentanyl is attractive due to its greater "rush" and potency in overcoming heroin tolerance. However, it also comes with a high risk of overdose and short duration of effect.

Q: What are the public health implications of fentanyl?

A: The proliferation of fentanyl has led to a significant increase in overdose deaths, with over 71,000 deaths involving synthetic opioids in the U.S. in 2022. Enhanced surveillance and comprehensive testing are critical to addressing this crisis.

Q: How challenging is it to regulate fentanyl?

A: Regulating fentanyl is highly challenging due to its clandestine production and distribution methods, which leverage the efficiency and anonymity of the illicit digital economy.

Sources:

1. Australian Institute of Criminology - Fentanyl availability on darknet markets[1].
2. U.S. Department of State - FY 2024 Congressional Budget Justification[2].
3. Centers for Disease Control and Prevention - Fighting Fentanyl: The Federal Response to a Growing Crisis[3].
4. Centers for Disease Control and Prevention - Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone[4].