Fentanyl hydrochloride - Generic Drug Details

What are the generic sources for fentanyl hydrochloride and what is the scope of patent protection?

Fentanyl hydrochloride is the generic ingredient in one branded drug marketed by The Medicines Co and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has eighty-six patent family members in eighteen countries.

There are two drug master file entries for fentanyl hydrochloride.

Summary for fentanyl hydrochloride

International Patents:	86
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	1,654
Patent Applications:	136
DailyMed Link:	fentanyl hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fentanyl hydrochloride

Dosage:

SYSTEM;IONTOPHORESIS, TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for fentanyl hydrochloride

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 hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl hydrochloride

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for fentanyl hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y

Expired US Patents for fentanyl hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006

International Patents for fentanyl hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	6246795
World Intellectual Property Organization (WIPO)	2012134767
Russian Federation	2557690	СПОСОБ И СХЕМА ПРОВЕРКИ ИСПРАВНОСТИ ВЫКЛЮЧАТЕЛЯ (METHOD AND CIRCUIT FOR TESTING SWITCH SERVICEABILITY)

Supplementary Protection Certificates for fentanyl hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006

Market Dynamics and Financial Trajectory of Fentanyl Hydrochloride

Overview of Fentanyl Hydrochloride

Fentanyl hydrochloride is a highly potent synthetic opioid, significantly more powerful than heroin and morphine. It is primarily used as an analgesic but has also become a major component in the illicit drug trade, contributing to a global opioid crisis[2].

Global Market Size and Growth

The broader opioids market, which includes fentanyl, is projected to grow from $22.74 billion in 2023 to around $26.78 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 1.5%. While this growth is modest, it indicates a steady demand for opioids, including fentanyl, in both medical and illicit contexts[1].

Regional Market Dynamics

• North America: This region holds the highest market share of the global opioids market, with 45.13% in 2023. The presence of fentanyl in the illicit drug market in North America is particularly significant, contributing to the opioid epidemic and high overdose rates[1].
• Asia-Pacific: This region is expected to expand at the fastest CAGR during the forecast period. Countries like China and India are emerging as key players in the production and trafficking of fentanyl and its precursors[1].

Application and Usage

• Pain Relief: The pain relief segment holds a major market share of 24% in the opioids market. Fentanyl, due to its potency, is often used for severe pain management, both in medical settings and illicitly[1].
• Anesthesia: The anesthesia segment is anticipated to grow at the fastest CAGR over the projected period. Fentanyl's use in anesthesia highlights its medical utility, but it also underscores the potential for diversion into the illicit market[1].

Route of Administration

• Injectable Segment: This segment holds the highest revenue share of 44% in the opioids market. Fentanyl's injectable form is particularly potent and is often misused in illicit contexts[1].
• Oral Segment: The oral segment is expected to expand at a CAGR of 2.5% over the predicted period. Oral fentanyl products, such as lozenges and tablets, are used both medically and illicitly[1].

Distribution Channels

• Retail Pharmacy: The retail pharmacy segment leads the market with the maximum market share of 38% in 2023. However, the illicit distribution of fentanyl often bypasses traditional retail channels, using darknet markets and other clandestine methods[1].

Illicit Market Dynamics

Trafficking and Production

• Fentanyl is widely trafficked by organized crime groups, who use various methods to produce and distribute the drug. This includes the use of precursor chemicals, which are often sourced from China and India[3][5].
• The drug is frequently mixed with other substances like heroin, cocaine, and benzodiazepines, increasing its potency and the risk of overdose[2].

Financial Aspects

• The illicit production and trafficking of fentanyl generate revenues worth tens of billions of dollars annually. Organized crime groups use complex money laundering techniques, including bulk cash smuggling, trade-based money laundering, and the use of virtual assets to move and hide their proceeds[3].
• A kilogram of fentanyl can be produced at a relatively low cost but can generate significant revenue when sold illicitly. For example, a kilogram of fentanyl can produce approximately 1 million counterfeit pills, potentially generating $10-20 million in revenue[4].

Darknet Markets

• Fentanyl and its analogues are widely available on darknet markets. These platforms use encrypted messaging, escrow services, and cryptocurrencies to facilitate transactions. Vendors on these markets often provide detailed product descriptions and use postal services for distribution[4].

Regulatory and Law Enforcement Efforts

• Governments and law enforcement agencies are increasingly targeting the illicit fentanyl supply chain. For instance, the U.S. Treasury has imposed financial sanctions on Chinese and Mexican entities involved in the production and distribution of fentanyl and other illicit substances[5].
• Initiatives such as the Biden-Harris Administration's $50 million program to support opioid treatment and recovery services in rural communities aim to address the public health crisis caused by fentanyl and other opioids[1].

Money Laundering and Financial Disruption

• Organized crime groups use various financial methods to launder the proceeds from fentanyl trafficking. This includes the use of shell and front companies, virtual assets, and unauthorized money or value transfer services. Disrupting these financial flows is a key strategy in combating the illicit fentanyl trade[3].

Key Players and Networks

• Entities like Hanhong Pharmaceutical Technology Co., LTD, Hebei Guanlang Biotechnology Co., LTD, and Qingdao Cemo Technology Develop Co., LTD have been identified as key players in the illicit production and distribution of fentanyl precursors. These networks operate globally, involving countries such as China, Mexico, and the United States[5].

Public Health Impact

• The spread of fentanyl has led to a significant increase in overdose deaths. In Canada and the United States alone, the trafficking of fentanyl is estimated to claim around 80,000 lives annually. The drug's potency and widespread contamination of other illicit substances have exacerbated the opioid epidemic[3].

Future Outlook

• The market dynamics of fentanyl are expected to remain complex, with ongoing challenges in regulating its medical use while combating its illicit distribution. The Asia-Pacific region's growing role in the production and trafficking of fentanyl precursors will likely continue to influence global market trends[1].

Key Takeaways

• Fentanyl hydrochloride is a highly potent opioid with significant medical and illicit market presence.
• The global opioids market, including fentanyl, is projected to grow modestly.
• North America and the Asia-Pacific region are critical in the fentanyl market dynamics.
• Illicit trafficking of fentanyl generates substantial revenues and involves complex money laundering techniques.
• Regulatory efforts are increasingly focused on disrupting the financial flows and production networks of illicit fentanyl.

FAQs

Q: What is the current market size of the global opioids market, and how is it expected to grow? A: The global opioids market was valued at $22.74 billion in 2023 and is expected to reach around $26.78 billion by 2034, growing at a CAGR of 1.5%[1].

Q: Which region is expected to expand the fastest in the opioids market? A: The Asia-Pacific region is estimated to expand at the fastest CAGR during the forecast period[1].

Q: How is fentanyl typically distributed in the illicit market? A: Fentanyl is often distributed through darknet markets, using postal services and cryptocurrencies, and is frequently mixed with other illicit substances[4].

Q: What are the primary methods used by organized crime groups to launder the proceeds from fentanyl trafficking? A: Organized crime groups use methods such as bulk cash smuggling, trade-based money laundering, and the use of virtual assets to launder their proceeds[3].

Q: What are some of the key regulatory efforts to combat the illicit fentanyl trade? A: Regulatory efforts include financial sanctions, targeting precursor supply chains, and disrupting financial flows. For example, the U.S. Treasury has imposed sanctions on entities involved in the production and distribution of fentanyl[5].

Sources

1. Biospace: Opioids Market Size to Worth Around USD 26.78 Billion by 2034
2. Wikipedia: Fentanyl
3. FATF/OECD: Money Laundering from Fentanyl and Synthetic Opioids
4. Australian Criminal Intelligence Commission: Fentanyl availability on darknet markets
5. U.S. Department of the Treasury: Treasury Targets Large Chinese Network of Illicit Drug Producers

Last updated: 2024-12-17