FENTANYL-62 Drug Patent Profile

When do Fentanyl-62 patents expire, and when can generic versions of Fentanyl-62 launch?

Fentanyl-62 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-62 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-62

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,654
Patent Applications:	4,381
DailyMed Link:	FENTANYL-62 at DailyMed

Recent Clinical Trials for FENTANYL-62

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-62 clinical trials

Pharmacology for FENTANYL-62

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-62

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-62	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-007	Dec 29, 2014	AB	RX	No	No
Specgx Llc	FENTANYL-62	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077154-007	Jan 14, 2020	AB	RX	No	No
Difgen Pharms	FENTANYL-62	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-007	Dec 6, 2017	AB	RX	No	No
Zydus Pharms	FENTANYL-62	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-005	Jan 24, 2023		DISCN	No	No

EU/EMA Drug Approvals for FENTANYL-62

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fentanyl	EMEA/H/C/000612 Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25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 Fentanyl Crisis: Understanding Market Dynamics and Financial Trajectory

Introduction

Fentanyl, a synthetic opioid 50-100 times more potent than morphine, has become a central figure in the global drug crisis. This article delves into the market dynamics and financial trajectory of fentanyl, highlighting its impact, production, distribution, and the economic implications of its spread.

The Rise of Fentanyl

Pre-Pandemic and Pandemic Trends

Before the COVID-19 pandemic, fentanyl was already a significant player in the opioid market. However, the pandemic accelerated its spread. Between 2019 and 2020, adolescent overdose deaths involving fentanyl increased by 177%, from 128 to 354 deaths[1].

Current Trends

As of 2023, fentanyl continues to dominate the opioid overdose landscape. The share of all drug overdose deaths involving fentanyl among adolescents has risen to 76%, surpassing the adult rate of 69%[1]. Despite a slight slowdown in the annual increase of fentanyl-related deaths among adolescents, the numbers remain alarmingly high.

Production and Export

Role of the PRC

The People's Republic of China (PRC) plays a critical role in the fentanyl crisis. The PRC government subsidizes the manufacturing and export of illicit fentanyl materials through tax rebates, even though these substances are illegal under PRC laws and have no known legal use worldwide[2].

Economic Incentives

These subsidies incentivize mass production and export of fentanyl and its analogues. Companies involved in the fentanyl trade receive monetary grants and awards, and some are even owned or supported by PRC government entities[2].

Impact of COVID-19 on Supply Chains

The COVID-19 lockdowns in China temporarily disrupted fentanyl supply chains, leading to a scarcity of fentanyl in the United States and a subsequent increase in prices. However, the supply chains quickly recovered, and fentanyl production resumed at pre-pandemic levels[2].

Distribution and Trafficking

Global Routes

Fentanyl is trafficked globally, with significant routes through South and Southwest Asia, the Near and Middle East, and into North America. The drug often reaches the U.S. through Mexico, where it is mixed with other substances or sold as counterfeit prescription medications[3][5].

Cryptocurrency and Blockchain

The use of cryptocurrency and blockchain technology has facilitated the tracking of fentanyl transactions. For instance, blockchain analysis has accurately predicted the amount of fentanyl seized at the U.S.-Mexico border based on cryptocurrency payments to PRC manufacturers[2].

Economic Implications

Cost to the U.S. Economy

The fentanyl crisis has had a devastating economic impact on the United States. In 2020, the crisis cost the U.S. nearly $1.5 trillion, or 7% of the gross domestic product. This includes costs related to healthcare, law enforcement, and lost productivity[2].

Global Economic Impact

Globally, the fentanyl crisis exacerbates poverty and unemployment, particularly in regions with limited access to essential controlled medicines. The COVID-19 pandemic further worsened these conditions, pushing over 100 million people into extreme poverty and creating an environment more susceptible to drug use[3].

Human Impact

Overdose Deaths and Addiction

Fentanyl has led to a significant increase in opioid overdose deaths. In the U.S., approximately half of the 70,630 drug overdose deaths in 2019 involved synthetic opioids, primarily fentanyl. The age-adjusted synthetic opioid death rates increased by 1040% from 2013 to 2019[5].

Family and Community Impact

The fentanyl crisis has devastated families and communities. Over 2.6 million children in the U.S. are being raised by other relatives due to their parents’ addiction. The crisis affects suburban, urban, and rural areas alike, leading to a historic drop in American life expectancy[2].

Regulatory Efforts

International Control

The World Health Organization (WHO) has placed several synthetic opioids, including fentanyl analogues, under international control to regulate their availability. This includes rigorous monitoring and surveillance to alert countries to potential dangers associated with these substances[5].

Surveillance and Monitoring

WHO supports countries in monitoring trends in drug use and related harm to better understand the scale of opioid dependence and overdose. Comprehensive testing of opioid overdose deaths is crucial due to the increasing distribution of fentanyl analogs in illicit markets[4][5].

Financial Trajectory of Fentanyl Traffickers

Money Laundering

The fentanyl crisis has enriched CCP-tied Chinese organized criminal groups, making them premier money launderers. These groups benefit economically from the crisis, which has also enriched the PRC’s chemical industry[2].

Tax Rebates and Subsidies

The PRC government's subsidies for fentanyl production and export have created a lucrative market. Companies involved in the fentanyl trade enjoy tax rebates and other financial incentives, despite the illicit nature of their activities[2].

Conclusion

The fentanyl crisis is a complex issue driven by a combination of factors including production subsidies, global trafficking routes, and economic incentives. Understanding these market dynamics is crucial for developing effective strategies to combat the crisis.

Key Takeaways

• Fentanyl overdose deaths among adolescents have increased significantly since the pandemic.
• The PRC government subsidizes the production and export of fentanyl.
• The crisis has severe economic and human impacts globally.
• Regulatory efforts, including international control and surveillance, are essential in combating the crisis.
• Financial incentives play a critical role in the fentanyl trafficking network.

FAQs

Q: What role does the PRC government play in the fentanyl crisis?

A: The PRC government subsidizes the manufacturing and export of illicit fentanyl materials through tax rebates and provides monetary grants to companies involved in the fentanyl trade[2].

Q: How has the COVID-19 pandemic affected fentanyl supply chains?

A: The pandemic temporarily disrupted fentanyl supply chains due to lockdowns in China, but the supply chains quickly recovered, and production resumed at pre-pandemic levels[2].

Q: What are the economic implications of the fentanyl crisis?

A: The crisis has cost the U.S. nearly $1.5 trillion in 2020 and has significant global economic impacts, including exacerbating poverty and unemployment[2][3].

Q: How does fentanyl affect communities and families?

A: The fentanyl crisis has devastated families, with over 2.6 million children in the U.S. being raised by other relatives due to their parents’ addiction. It affects suburban, urban, and rural areas alike[2].

Q: What regulatory efforts are in place to combat the fentanyl crisis?

A: The WHO has placed fentanyl and its analogues under international control, and there are ongoing efforts to monitor trends in drug use and related harm[5].

Sources

1. KFF, Teens, Drugs, and Overdose: Contrasting Pre-Pandemic and Current Trends, October 15, 2024.
2. House.gov, THE CCP'S ROLE IN THE FENTANYL CRISIS, September 7, 2021.
3. UNODC, DRUG MARKET TRENDS: CANNABIS OPIOIDS, 2021.
4. CDC, Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone, September 1, 2017.
5. WHO, Opioid overdose, August 29, 2023.