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Last Updated: December 22, 2024

FENTANYL CITRATE Drug Patent Profile


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Which patents cover Fentanyl Citrate, and when can generic versions of Fentanyl Citrate launch?

Fentanyl Citrate is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys. and is included in nineteen NDAs.

The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.

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Drug patent expirations by year for FENTANYL CITRATE
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Recent Clinical Trials for FENTANYL CITRATE

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

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

See all FENTANYL CITRATE clinical trials

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
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072028-001 Apr 13, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-006 Oct 30, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 072786-001 Sep 24, 1991 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-002 Oct 30, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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