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Last Updated: June 14, 2025

Fentanyl citrate - Generic Drug Details


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

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 four 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 thirty-five patent family members in thirty-three countries.

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

Drug Prices for fentanyl citrate

See drug prices for fentanyl citrate

Recent Clinical Trials for fentanyl citrate

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

SponsorPhase
Ambulance AmsterdamPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 3
Stichting ZiektekostenVerzekering KrijgsmachtPhase 3

See all fentanyl citrate clinical trials

Generic filers with tentative approvals for FENTANYL CITRATE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for FreeEQ 0.05MG BASE/MLINJECTABLE;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 ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actavis Labs Fl Inc FENTANYL CITRATE fentanyl citrate TABLET;SUBLINGUAL 207338-004 Nov 17, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-004 Oct 30, 2009 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 079075-001 Jan 7, 2011 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fentanyl citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 ⤷  Try for Free ⤷  Try for Free
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 ⤷  Try for Free ⤷  Try for Free
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 ⤷  Try for Free ⤷  Try for Free
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-003 Dec 21, 2015 ⤷  Try for Free ⤷  Try for Free
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fentanyl citrate

Country Patent Number Title Estimated Expiration
Portugal 1708686 ⤷  Try for Free
South Korea 20060127944 GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2005065318 ⤷  Try for Free
Denmark 1708686 ⤷  Try for Free
Mexico 2009000745 DISPOSITIVOS DE SUMINISTRO TRANSMUCOSA CON ADMISION MEJORADA. (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE.) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 122014000024 Germany ⤷  Try for Free PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368 C300523 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785 C300521 Netherlands ⤷  Try for Free PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark ⤷  Try for Free PRODUCT NAME: FENTANYL HYDROCHLORID
0383579 C960030 Netherlands ⤷  Try for Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.
Last updated: 2024-12-16

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