FENTANYL-37 Drug Patent Profile

When do Fentanyl-37 patents expire, and what generic alternatives are available?

Fentanyl-37 is a drug marketed by Difgen Pharms, Mylan Technologies, Specgx Llc, and Zydus Pharms. and is included in four NDAs.

The generic ingredient in FENTANYL-37 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-37

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,654
Patent Applications:	4,383
DailyMed Link:	FENTANYL-37 at DailyMed

Recent Clinical Trials for FENTANYL-37

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-37 clinical trials

Pharmacology for FENTANYL-37

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-37

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Technologies	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-006	Dec 29, 2014	AB	RX	No	No
Specgx Llc	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-006	Jan 14, 2020	AB	RX	No	No
Difgen Pharms	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-006	Dec 6, 2017	AB	RX	No	No
Zydus Pharms	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-003	Jan 24, 2023		DISCN	No	No

EU/EMA Drug Approvals for FENTANYL-37

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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fentanyl	EMEA/H/C/000612 Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25
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
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
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
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

The Market Dynamics and Financial Trajectory of Fentanyl

Introduction

Fentanyl, a potent synthetic opioid, has significantly impacted global drug markets and public health. This article delves into the market dynamics, financial aspects, and the broader implications of fentanyl trafficking.

Global Spread and Impact

Fentanyl has entered illicit drug markets worldwide, particularly exacerbating the opioid epidemic in North America. Its high potency and ease of modification have led to the production of numerous derivatives, such as 3-methylfuranylfentanyl and carfentanil, further complicating the drug landscape[1][3][4].

Darknet Markets and Online Distribution

Fentanyl and its analogues are widely available on darknet markets, which operate as e-commerce platforms for illicit substances. These markets use postal services for distribution, often involving small quantities of highly potent opioids. Vendors provide detailed product descriptions, quantities, prices, and shipping services, while market administrators charge commissions and offer escrow services[1].

Market Structure

• Markets like Dream Market and Berlusconi have been significant players, though they have faced operational challenges such as distributed denial-of-service attacks and law enforcement actions.
• Despite these challenges, these markets continue to facilitate the sale of fentanyl and other opioids, albeit with occasional bans on certain products[1].

Financial Transactions

• Transactions on these platforms often involve cryptocurrencies like Bitcoin to maintain anonymity.
• Vendors may exchange these cryptocurrencies for traditional fiat currencies using unlicensed money transmitters, further complicating financial tracking[2].

Economic and Financial Aspects

Illicit Proceeds

• The fentanyl trade generates billions of dollars in illicit proceeds, which are often laundered through various methods, including bulk cash smuggling and trade-based money laundering (TBML).
• TBML involves using illicit proceeds to purchase goods for export, effectively laundering the money through legitimate trade channels[2].

Bulk Cash Smuggling

• Significant amounts of bulk cash are smuggled across borders, particularly from the U.S. to Mexico, to pay for drug shipments.
• This method is risky and has led to substantial seizures by law enforcement, but it remains a common practice[2].

Trade-Based Money Laundering

• TBML schemes convert bulk currency into goods with equivalent monetary value, such as smartphones or jewelry, to launder the proceeds.
• This method is less conspicuous than bulk cash smuggling and involves complex transactions often facilitated by external brokers[2].

Market Value and Potency

• A small quantity of fentanyl can produce a large amount of synthetic heroin. For example, 10 grams of fentanyl 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].

Comparative Value

• The potency of fentanyl amplifies its impact despite the relatively low number of listings compared to other drugs. For instance, a mere 16.8 milligrams of fentanyl can produce 5.5 grams of heroin equivalent, highlighting its high value and danger[1].

Public Health and Policy Implications

Opioid Epidemic

• The spread of fentanyl has dramatically 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].

Decriminalization and Overdose Rates

• Studies have shown that the rapid spread of fentanyl in unregulated drug markets significantly increases overdose mortality. However, the impact of drug decriminalization policies on overdose rates is complex and requires careful analysis to account for the heterogeneous spread of fentanyl[4].

Global Disparities

• The COVID-19 pandemic has exacerbated drug use and trafficking by creating economic instability and increasing susceptibility to drug use. Disparities in access to controlled pain medications also persist, with regions like West and Central Africa having significantly fewer doses available compared to North America[3].

Law Enforcement and Regulatory Efforts

Financial Monitoring

• Financial institutions play a crucial role in detecting and reporting suspicious activities related to fentanyl trafficking. Advisories from agencies like FinCEN help in identifying red flags and typologies associated with fentanyl sales and money laundering[2].

International Cooperation

• Collaboration between U.S. and foreign partners, including Mexico, is essential in combating the fentanyl epidemic. Efforts include sharing intelligence and coordinating law enforcement actions to disrupt trafficking networks[2].

User Demand and Harm Reduction

Opioid Agonists

• There is a notable demand for harm reduction and self-medicated recovery among opioid users. Listings for opioid agonists like methadone, buprenorphine, and naloxone on darknet markets indicate a need for safer alternatives and recovery tools[1].

Conclusion

The market dynamics of fentanyl are characterized by its high potency, ease of distribution through darknet markets, and complex financial transactions. The economic and public health impacts are severe, with significant increases in overdose mortality and illicit financial activities. Addressing the fentanyl epidemic requires coordinated law enforcement efforts, financial monitoring, and public health strategies to mitigate its effects.

Key Takeaways

• High Potency and Ease of Modification: Fentanyl's potency and ease of modification have led to a proliferation of dangerous derivatives.
• Darknet Markets: Fentanyl is widely available on darknet markets, which use cryptocurrencies and postal services for distribution.
• Financial Complexity: Illicit proceeds are laundered through bulk cash smuggling and trade-based money laundering.
• Public Health Impact: The spread of fentanyl has significantly increased overdose mortality rates.
• Global Disparities: Economic instability and disparities in access to pain medications exacerbate the drug problem.
• Law Enforcement Efforts: Financial monitoring and international cooperation are crucial in combating fentanyl trafficking.

FAQs

Q: How is fentanyl distributed on darknet markets?

A: Fentanyl is distributed on darknet markets through online vendors who use postal services for delivery. Transactions are often conducted using cryptocurrencies like Bitcoin.

Q: What are the financial implications of fentanyl trafficking?

A: Fentanyl trafficking generates significant illicit proceeds, which are laundered through methods such as bulk cash smuggling and trade-based money laundering.

Q: How has the COVID-19 pandemic affected drug use and trafficking?

A: The COVID-19 pandemic has exacerbated economic instability, increased susceptibility to drug use, and disrupted but not halted drug trafficking operations.

Q: What is the impact of fentanyl on overdose mortality rates?

A: The spread of fentanyl has dramatically increased overdose mortality rates, with a 1200% increase in the U.S. between 2014 and 2021.

Q: How do law enforcement and financial institutions combat fentanyl trafficking?

A: Law enforcement and financial institutions collaborate to detect and report suspicious activities, share intelligence, and disrupt trafficking networks through coordinated efforts.

Sources

1. Australian Institute of Criminology. (2020). Fentanyl availability on darknet markets. Retrieved from https://www.aic.gov.au/sites/default/files/2020-05/ti590_fentanyl_availability_on_darknet_markets.pdf
2. FinCEN. (2019). FinCEN Advisory FIN-2019-A006. Retrieved from https://www.fincen.gov/sites/default/files/advisory/2019-08-21/Fentanyl%20Advisory%20FINAL%20508.pdf
3. United Nations Office on Drugs and Crime. (2021). DRUG MARKET TRENDS: CANNABIS OPIOIDS. Retrieved from https://www.unodc.org/res/wdr2021/field/WDR21_Booklet_3.pdf
4. JAMA Network Open. (2024). Drug Decriminalization, Fentanyl, and Fatal Overdoses in Oregon. Retrieved from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2823254