Fentanyl citrate - Generic Drug Details

What are the generic sources for fentanyl citrate and what is the scope of freedom to operate?

Fentanyl citrate is the generic ingredient in nine branded drugs marketed by Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Btcp Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-two NDAs. There are ten patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has one hundred and seventy-two patent family members in thirty-five countries.

There are fifteen drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fentanyl citrate

International Patents:	172
US Patents:	10
Tradenames:	9
Applicants:	16
NDAs:	22
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	106
Patent Applications:	6,430
Drug Prices:	Drug price trends for fentanyl citrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fentanyl citrate
What excipients (inactive ingredients) are in fentanyl citrate?	fentanyl citrate excipients list
DailyMed Link:	fentanyl citrate at DailyMed

See drug prices for fentanyl citrate

Recent Clinical Trials for fentanyl citrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stichting ZiektekostenVerzekering Krijgsmacht	Phase 3
Ambulance Amsterdam	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3

See all fentanyl citrate clinical trials

Generic filers with tentative approvals for FENTANYL CITRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.05MG BASE/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fentanyl citrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl citrate

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

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for FENTANYL CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19
FENTORA	Buccal Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	021947	1	2007-11-13
ACTIQ	Lozenges	fentanyl citrate	0.6 mg	020747		2004-12-20
ACTIQ	Lozenges	fentanyl citrate	0.8 mg, 1.2 mg and 1.6 mg	020747		2004-11-22
ACTIQ	Lozenges	fentanyl citrate	0.2 mg	020747		2004-10-29
ACTIQ	Lozenges	fentanyl citrate	0.4 mg	020747		2004-10-06

US Patents and Regulatory Information for fentanyl citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	072786-001	Sep 24, 1991	AP	RX	No	No
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-002	Oct 30, 2009		DISCN	No	No
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-004	Nov 17, 2017		DISCN	No	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-002	Nov 17, 2017		DISCN	No	No
Fresenius Kabi Usa	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	210762-001	May 3, 2019	AP	RX	No	No

Expired US Patents for fentanyl citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-006	Mar 2, 2007
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006

International Patents for fentanyl citrate

Country	Patent Number	Title	Estimated Expiration
China	100423709
Taiwan	201247491	Improved container
Brazil	PI0714712	dispositivos de distribuiÇço transmucosal com absorÇço intensificada
South Korea	20050103275	PHARMACEUTICAL COMPOSITIONS COMPRISING FENTANYL FOR INTRANASAL DELIVERY
Canada	2548915	FORME GALENIQUE DE FENTANYL GENERALEMENT LINEAIRE EFFERVESCENTE ET ORALE ET SES PROCEDES D'ADMINISTRATION (GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING)
Eurasian Patent Organization	008500	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for fentanyl citrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783	132014902242643	Italy		PRODUCT NAME: FENTANIL IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(PECFENT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/10/644/001-004, 20100831
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126

Fentanyl citrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fentanyl Citrate

Introduction to Fentanyl Citrate

Fentanyl citrate, a potent synthetic opioid, has been at the forefront of both medical and illicit drug markets. Its use spans from pain management and anesthesia to illicit drug trafficking, making it a complex and multifaceted market.

Market Size and Growth Projections

The global fentanyl market, including fentanyl citrate, has experienced significant growth in recent years. As of 2023, the market size was valued at $15.14 billion and is projected to grow to $16.22 billion in 2024, with a compound annual growth rate (CAGR) of 7.2%[4].

By 2028, the market is expected to reach $20.79 billion, driven by factors such as the rise in chronic pain cases, expanding oncology therapies, and increasing surgical procedures[4].

Segmentation of the Fentanyl Market

The fentanyl market is segmented based on several key factors:

Type

• Fentanyl injections
• Fentanyl TTS (Transdermal Therapeutic System)
• Other forms such as solutions and powders[4].

Application

• Induction and maintenance of anesthesia
• General analgesic use
• Postoperative analgesia
• Breakthrough cancer pain management[4].

End User

• Hospitals
• Clinics
• Ambulatory surgical centers
• Other healthcare facilities[4].

Geographical Analysis

The fentanyl market is spread across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region, particularly China and India, plays a significant role due to its large population and growing healthcare needs[1][4].

Drivers of the Market

Several factors drive the growth of the fentanyl market:

Pain Management Needs

The increasing prevalence of chronic pain and the need for effective pain management solutions are key drivers[4].

Medical Procedures and Surgeries

The rise in surgical procedures and medical interventions that require anesthesia and analgesia contributes to market growth[4].

Aging Population

An aging population with increased healthcare needs, including pain management, is another significant driver[4].

Restraints and Challenges

Despite the growth, the market faces several challenges:

Regulatory Scrutiny

Strict regulations and oversight, particularly in the context of the opioid epidemic, can limit market expansion[4].

Illicit Use and Trafficking

The illicit use and trafficking of fentanyl pose significant challenges, both in terms of public health and market dynamics[2].

Economic Impact

The opioid epidemic, including fentanyl, has a devastating economic impact, estimated to have cost the U.S. nearly $1.5 trillion in 2020[5].

Illicit Fentanyl Supply Chain

The illicit fentanyl supply chain is complex and involves several key actors:

Mexican Cartels and Chinese Money Laundering Organizations (CMLOs)

Mexican cartels, such as the Sinaloa Cartel and La Linea, work with CMLOs to manufacture and distribute fentanyl. CMLOs facilitate transactions through cryptocurrencies and informal banking systems, making it difficult for law enforcement to track[2].

Use of Cryptocurrencies

Cryptocurrencies like Bitcoin, Tron, and Ethereum are used to purchase precursor chemicals for fentanyl production. In 2023, cryptocurrency payments to Chinese precursor manufacturers surged significantly, highlighting the growing role of cryptocurrencies in illicit transactions[2].

Impact of Financial Sanctions

Financial sanctions have proven effective in disrupting the illicit fentanyl trade:

Reducing Crypto-Denominated Sales

Sanctions have driven down the growth rate of crypto-denominated fentanyl sales, from an average of 150% between 2019 and 2022 to about 60% in 2023[2].

Targeting Key Actors

The U.S. Department of the Treasury has sanctioned over 350 foreign entities and individuals involved in drug trafficking, including those responsible for manufacturing fentanyl precursors in China[2].

Public Health and Economic Impact

The fentanyl epidemic has severe public health and economic consequences:

Mortality Rates

Fentanyl is one of the leading causes of death among young and middle-aged Americans, with nearly 75,000 deaths in 2023 alone[2].

Economic Toll

The opioid epidemic, including fentanyl, costs the U.S. economy significantly, with estimates suggesting a cost of nearly $1.5 trillion in 2020[5].

Technological Advancements and Detection

Technological innovations are crucial in the fight against fentanyl:

Detection Technologies

Advancements in detection technologies help in identifying and tracking fentanyl, both in medical and illicit contexts[4].

Blockchain Intelligence

Companies like TRM Labs use blockchain intelligence to track cryptocurrency transactions related to fentanyl, aiding in the disruption of illicit networks[2].

Conclusion

The fentanyl citrate market is characterized by strong growth driven by medical needs, but it is also marred by the challenges of illicit use and trafficking. Financial sanctions and technological advancements are key tools in combating the illicit trade, while regulatory oversight and public health initiatives aim to balance the medical use of fentanyl with the need to mitigate its harmful effects.

Key Takeaways

• The global fentanyl market is projected to grow significantly, driven by medical needs.
• Illicit fentanyl trafficking poses a major public health and economic threat.
• Financial sanctions and technological advancements are crucial in disrupting the illicit fentanyl supply chain.
• Regulatory scrutiny and public health initiatives are essential in managing the dual nature of fentanyl.

Frequently Asked Questions

Q: What is the current market size of the fentanyl citrate market? A: As of 2023, the global fentanyl market size was valued at $15.14 billion[4].

Q: How is the illicit fentanyl supply chain facilitated? A: The illicit fentanyl supply chain involves Mexican cartels and Chinese money laundering organizations, with transactions often facilitated through cryptocurrencies and informal banking systems[2].

Q: What is the impact of financial sanctions on the illicit fentanyl trade? A: Financial sanctions have reduced the growth rate of crypto-denominated fentanyl sales and targeted key actors in the supply chain[2].

Q: What are the main drivers of the fentanyl market growth? A: Drivers include pain management needs, medical procedures and surgeries, and an aging population[4].

Q: How does the opioid epidemic, including fentanyl, affect the economy? A: The opioid epidemic has a significant economic impact, estimated to have cost the U.S. nearly $1.5 trillion in 2020[5].

Sources:

1. MarketResearchIntellect, Global Fentanyl Citrate Sales Market Size, Scope And Forecast Report, November 2024.
2. Atlantic Council, Financial sanctions can disrupt fentanyl flows to the United States, October 31, 2024.
3. Department of Homeland Security, Proceedings from the 2017 Fentanyl Working Meeting, September 7, 2017.
4. The Business Research Company, Global Fentanyl Market Report 2024.
5. U.S. Department of the Treasury, Remarks by Secretary of the Treasury Janet L. Yellen on New Treasury Actions to Counter Illicit Financing Tied to Fentanyl in Mexico City.