FENTANYL-100 Drug Patent Profile

Which patents cover Fentanyl-100, and what generic alternatives are available?

Fentanyl-100 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-100 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-100

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,654
Patent Applications:	3,633
DailyMed Link:	FENTANYL-100 at DailyMed

Recent Clinical Trials for FENTANYL-100

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-100 clinical trials

Pharmacology for FENTANYL-100

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-100

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-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-004	Aug 20, 2007		DISCN	No	No
Noven	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077775-004	Oct 16, 2009		DISCN	No	No
Lavipharm Labs	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077051-004	Aug 4, 2006		DISCN	No	No
Specgx Llc	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-004	Feb 9, 2011	AB	RX	No	No
Difgen Pharms	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-004	Oct 20, 2008	AB	RX	No	No
Kindeva	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	202097-005	Nov 4, 2016	AB	RX	No	No
Mylan Technologies	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-004	Jan 28, 2005	AB	RX	No	No

EU/EMA Drug Approvals for FENTANYL-100

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

FENTANYL-100 Market Analysis and Financial Projection Experimental

The Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a synthetic opioid 30 to 100 times more potent than morphine, has dramatically altered the landscape of the illicit drug market. This article delves into the market dynamics and financial trajectory of fentanyl, highlighting its impact, distribution channels, and the economic factors driving its proliferation.

Fentanyl's Rise in the Illicit Drug Market

Fentanyl has saturated many U.S. drug markets, serving as a cheaper and more potent replacement for heroin and infiltrating markets where heroin was previously rare or absent[3].

Replacement for Heroin

Fentanyl's lower production costs and higher potency make it an attractive alternative to heroin. It is often mixed with other substances like cocaine and methamphetamine, contributing to a significant rise in fatal overdoses[3].

Geographic Spread

The drug has spread across various U.S. regions, with the Northeast, Midwest, and South experiencing high and stable percentages of overdose deaths involving fentanyl from 2021 to 2024. The West has seen a recent surge, with overdose deaths involving fentanyl increasing by 33.9% from 2022 to 2023[1].

Distribution Channels

Darknet Markets

Fentanyl and its analogues are widely available on darknet markets, where online vendors use postal services to distribute small quantities. These markets operate with escrow services and commissions, facilitating the global supply of synthetic opioids[2].

Traditional Trafficking Routes

Fentanyl often enters the U.S. through the U.S.-Mexico border, while fentanyl analogues are frequently purchased directly over the internet or dark web, often from China, and shipped via international mail or express package services[4].

Financial Aspects of Fentanyl Trafficking

Profit Margins

The financial gains from fentanyl trafficking are substantial. One kilogram of fentanyl, purchased for $3,000 to $5,200, can be pressed into pills containing 1.5 milligrams of fentanyl and sold for $10 each, generating approximately $6.6 million in revenue[4].

Production Costs

The tools needed to manufacture counterfeit pills, such as pill presses and molds, are relatively inexpensive and available online. This accessibility contributes to the high profit margins for traffickers[4].

Impact on the Illicit Drug Market

Market Saturation

In regions where fentanyl has saturated the drug supply, the percentage of overdose deaths involving fentanyl has stabilized at a high level. This saturation might lead to lower overdose risk as users develop tolerance and become more aware of the presence of fentanyl in their drugs[1].

Mixing with Other Substances

Fentanyl is often mixed with non-opioid drugs like xylazine, which can reduce fentanyl purity and potentially decrease overdose risk. However, this mixing also increases the complexity and danger of the drug supply[1].

The Role of Fentanyl Analogues

Carfentanil

Carfentanil, a fentanyl analogue 100 times more potent than fentanyl, has reemerged in the U.S. drug supply. Its presence is particularly concerning due to its high potency and the potential for it to be mixed into fentanyl products without the user's knowledge[1].

Other Analogues

Other fentanyl analogues, such as 3-methylfuranylfentanyl and cyclopropyl fentanyl, are also trafficked and contribute to the complexity and danger of the illicit opioid market. These analogues are often created by modifying fentanyl's chemical structure to evade legal classification as controlled substances[4].

Law Enforcement and Regulatory Challenges

Trafficking Patterns

Fentanyl and its analogues are frequently trafficked in illicit drug marketplaces on the dark web. Law enforcement faces challenges in tracking these transactions due to the use of cryptocurrencies and encrypted communication[4].

Seizures and Enforcement

Recent seizures, such as the 23,368-kilogram shipment of fentanyl seized in Mexico, highlight the scale of the illicit market. However, these efforts are often outpaced by the adaptability of traffickers and the global nature of the supply chain[2].

Economic Impact

Revenue for Traffickers

The illicit fentanyl market generates significant revenue for traffickers. For example, a single kilogram of fentanyl can produce millions of dollars in revenue, making it a lucrative business for organized crime groups[4].

Broader Economic Implications

The economic impact extends beyond the illicit market. The opioid epidemic, driven in part by fentanyl, imposes substantial costs on healthcare systems, law enforcement, and the broader economy through lost productivity and other indirect costs.

Public Health Implications

Overdose Deaths

The introduction of fentanyl and its analogues has led to a sharp rise in overdose deaths due to their high potency and rapid onset of effects. In 2023, approximately 72,000 drug overdose deaths in the U.S. involved fentanyl, highlighting the public health crisis[1].

Tolerance and Awareness

As fentanyl saturates the drug supply, users may develop tolerance, and awareness about the presence of fentanyl in drugs may increase. However, the mixing of fentanyl with other substances and the emergence of more potent analogues like carfentanil continue to pose significant risks[1].

Conclusion

Fentanyl's impact on the illicit drug market is profound, driven by its potency, lower production costs, and widespread distribution. The financial trajectory of fentanyl trafficking is marked by high profit margins and significant revenue for traffickers. However, this comes at a devastating cost in terms of public health, with thousands of overdose deaths annually.

Key Takeaways

• Market Saturation: Fentanyl has saturated many U.S. drug markets, leading to a stabilization of overdose deaths in some regions.
• Financial Gains: Traffickers generate substantial revenue from fentanyl, with high profit margins due to low production costs.
• Public Health Crisis: The introduction of fentanyl and its analogues has led to a significant increase in overdose deaths.
• Distribution Channels: Fentanyl is distributed through darknet markets and traditional trafficking routes.
• Regulatory Challenges: Law enforcement faces challenges in tracking and disrupting fentanyl trafficking due to its global nature and use of advanced technologies.

FAQs

Q: How potent is fentanyl compared to other opioids? A: Fentanyl is approximately 30 to 100 times more potent than morphine, and carfentanil, a fentanyl analogue, is 100 times more potent than fentanyl[1][4].

Q: What are the primary distribution channels for fentanyl? A: Fentanyl is distributed through darknet markets and traditional trafficking routes, including the U.S.-Mexico border and international mail services[2][4].

Q: How has the emergence of fentanyl affected overdose deaths? A: The introduction of fentanyl has led to a sharp rise in overdose deaths due to its high potency and rapid onset of effects. In 2023, approximately 72,000 drug overdose deaths in the U.S. involved fentanyl[1].

Q: What are the financial gains from fentanyl trafficking? A: Traffickers can generate approximately $6.6 million in revenue from one kilogram of fentanyl, highlighting the high profit margins involved[4].

Q: How do law enforcement and regulatory efforts impact fentanyl trafficking? A: Law enforcement faces challenges in tracking and disrupting fentanyl trafficking due to its global nature and the use of advanced technologies. Recent seizures and enforcement efforts have had limited impact on the overall supply chain[2][4].

Sources

1. CDC: Detection of Illegally Manufactured Fentanyls and Carfentanil... - CDC
2. Australian Institute of Criminology: Fentanyl availability on darknet markets
3. Brookings Institution: The dynamics of US drug markets
4. U.S. Sentencing Commission: Fentanyl Analogues - U.S. Sentencing Commission
5. RAND: Afghanistan in the Era of Fentanyl