FENTANYL-87 Drug Patent Profile

Which patents cover Fentanyl-87, and what generic alternatives are available?

Fentanyl-87 is a drug marketed by Difgen Pharms, Mylan Technologies, and Zydus Pharms. and is included in three NDAs.

The generic ingredient in FENTANYL-87 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-87

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,654
Patent Applications:	2,209
DailyMed Link:	FENTANYL-87 at DailyMed

Recent Clinical Trials for FENTANYL-87

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-87 clinical trials

Pharmacology for FENTANYL-87

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for FENTANYL-87

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-87	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-008	Dec 6, 2017	AB	RX	No	No
Mylan Technologies	FENTANYL-87	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-008	Dec 29, 2014	AB	RX	No	No
Zydus Pharms	FENTANYL-87	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-007	Jan 24, 2023		DISCN	No	No

EU/EMA Drug Approvals for FENTANYL-87

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-87 Market Analysis and Financial Projection Experimental

The Fentanyl Crisis: Understanding Market Dynamics and Financial Trajectory

Introduction

Fentanyl, a synthetic opioid, has become a pivotal player in the global illicit drug market, wreaking havoc on public health and economies worldwide. This article delves into the market dynamics and financial trajectory of fentanyl, highlighting its production, distribution, and the economic implications of its trade.

Production and Supply Chain

Global Production Hubs

Fentanyl production is largely centered in China, particularly in the Hubei and Hebei provinces. These regions are known for supplying fentanyl precursors to cartels, which then manufacture the final product[2].

Impact of COVID-19 on Supply Chains

The COVID-19 pandemic temporarily disrupted fentanyl supply chains when China locked down key production areas. This led to a scarcity of fentanyl in the United States, causing prices to skyrocket. However, cartels quickly adapted, and supply chains returned to pre-pandemic levels once restrictions were lifted[2].

Market Availability and Distribution

Darknet Markets

Fentanyl is widely available on darknet markets, where it is sold in various forms, including powder, patches, and counterfeit pills. These markets operate globally, with vendors using postal services for distribution. For instance, between January and March 2019, over 1,100 listings for fentanyl and its analogues were identified on several popular darknet markets[1].

Physical Forms and Pricing

On darknet markets, fentanyl is often listed under colloquial names like "China White" and can be found in proprietary prescription forms. The average price of fentanyl on these markets was around A$99 per gram, while carfentanil, a more potent analogue, was priced at A$26.8 per gram[1].

Economic Implications

Revenue Generation

Criminal organizations reap significant profits from fentanyl. For example, one kilogram of fentanyl can produce approximately 1 million counterfeit pills, potentially generating $10-20 million in revenue. This lucrative trade has made PRC-tied Chinese organized criminal groups major players in global money laundering[1][2].

Subsidies and Tax Rebates

The Chinese government has been accused of subsidizing the manufacture and export of fentanyl through tax rebates, even though these substances are illegal under Chinese law. These subsidies have no legitimate rationale and contribute to the global fentanyl crisis[2].

Economic Impact on the United States

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

Consumer Demand and Preferences

User Preferences

Some heroin users prefer fentanyl due to its greater potency and the intense "rush" it provides, despite the higher risk of overdose and shorter duration of effect. This preference is evident in the demand for harm reduction products, such as methadone and naloxone, on darknet markets[1].

Harm Reduction and Self-Medication

The presence of opioid agonists like methadone and buprenorphine on darknet markets indicates user demand for harm reduction and self-medicated recovery. This highlights the complex nature of opioid addiction and the need for comprehensive treatment approaches[1].

Law Enforcement and Countermeasures

U.S. Treasury's Counter-Fentanyl Strike Force

The U.S. Department of the Treasury has launched a Counter-Fentanyl Strike Force to disrupt the global illicit fentanyl supply chain. This initiative involves using financial intelligence, imposing sanctions, and collaborating with international partners to identify and disrupt transnational criminal organizations[5].

Financial Intelligence and Sanctions

The Treasury Department has imposed nearly 250 sanctions on individuals and entities involved in the trafficking of illicit drugs, with a focus on the fentanyl supply chain. This includes leveraging financial intelligence to map TCO financial networks and strengthen international standards against money laundering[5].

Human Impact and Public Health

Mortality Rates

Fentanyl is a leading cause of death in the United States, particularly among Americans aged 18-45. On average, fentanyl kills over 200 Americans daily, contributing to a historic drop in American life expectancy[2].

Family and Community Impact

The fentanyl crisis has devastated families, with over 2.6 million children being raised by other relatives due to their parents’ addiction. It has also impacted communities across the country, affecting suburban, urban, and rural areas alike[2].

Global Trends and Challenges

COVID-19 and Economic Vulnerability

The COVID-19 pandemic has exacerbated economic vulnerabilities globally, pushing over 100 million people into extreme poverty and increasing susceptibility to drug use. This has created favorable conditions for drug traffickers to recover and operate at pre-pandemic levels[3].

Disparities in Access to Controlled Medicines

There are significant disparities in access to controlled pain medications worldwide. For instance, in West and Central Africa, only four standard doses of controlled pain medication are available per million inhabitants daily, compared to 32,000 doses in North America[3].

Key Takeaways

• Global Production: Fentanyl production is largely centered in China, with significant implications for global supply chains.
• Market Availability: Fentanyl is widely available on darknet markets, with vendors using postal services for distribution.
• Economic Impact: The fentanyl crisis has a substantial economic impact, costing the U.S. nearly $1.5 trillion in 2020.
• Consumer Demand: Users often prefer fentanyl for its potency, despite higher overdose risks.
• Law Enforcement: Efforts to disrupt the fentanyl supply chain include financial intelligence, sanctions, and international collaboration.
• Human Impact: Fentanyl is a leading cause of death in the U.S., with devastating effects on families and communities.

FAQs

Q: Where is fentanyl primarily produced?

A: Fentanyl is primarily produced in China, particularly in the Hubei and Hebei provinces.

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

A: The pandemic temporarily disrupted fentanyl supply chains due to lockdowns in key production areas, but supply chains quickly recovered once restrictions were lifted.

Q: What is the average price of fentanyl on darknet markets?

A: The average price of fentanyl on darknet markets was around A$99 per gram during the period studied.

Q: How does the Chinese government support the fentanyl trade?

A: The Chinese government has been accused of subsidizing the manufacture and export of fentanyl through tax rebates, despite these substances being illegal under Chinese law.

Q: What is the economic impact of the fentanyl crisis in the United States?

A: The fentanyl crisis cost the U.S. nearly $1.5 trillion in 2020, or about 7% of the GDP.

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Sources:

1. Australian Institute of Criminology - Fentanyl availability on darknet markets[1]
2. House.gov - The CCP's Role in the Fentanyl Crisis[2]
3. UNODC - Drug Market Trends: Cannabis Opioids[3]
4. CDC - Trends in Deaths Involving Heroin and Synthetic Opioids Excluding Methadone[4]
5. U.S. Treasury - U.S. Treasury Launches Counter-Fentanyl Strike Force[5]