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Last Updated: December 22, 2024

DROPERIDOL; FENTANYL CITRATE - Generic Drug Details


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

Droperidol; fentanyl citrate is the generic ingredient in two branded drugs marketed by Astrazeneca, Hospira, and Epic Pharma Llc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for DROPERIDOL; FENTANYL CITRATE
US Patents:0
Tradenames:2
Applicants:3
NDAs:5
DailyMed Link:DROPERIDOL; FENTANYL CITRATE at DailyMed

US Patents and Regulatory Information for DROPERIDOL; 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 AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 071982-001 May 4, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc INNOVAR droperidol; fentanyl citrate INJECTABLE;INJECTION 016049-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072026-001 Apr 13, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072028-001 Apr 13, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca FENTANYL CITRATE AND DROPERIDOL droperidol; fentanyl citrate INJECTABLE;INJECTION 072027-001 Apr 13, 1989 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

DROPERIDOL; FENTANYL CITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Droperidol and Fentanyl Citrate

Introduction

Droperidol and fentanyl citrate are potent pharmaceuticals used in various medical contexts, including surgery, pain management, and palliative care. Understanding their market dynamics and financial trajectories is crucial for pharmaceutical companies, healthcare providers, and investors.

Historical Context and Development

Discovery and Synthesis

Both droperidol and fentanyl citrate were synthesized in the research laboratories of Janssen Pharmaceutica in Belgium. Droperidol, a butyrophenone derivative, and fentanyl citrate, a highly potent analgesic, have been used since the mid-20th century for their rapid onset and short duration of action[4].

Medical Uses

Droperidol

Droperidol is primarily used for its antipsychotic and antiemetic properties, as well as in neuroleptanalgesia. It is often combined with fentanyl citrate for surgical procedures to induce sedation and analgesia. Droperidol's effectiveness in reducing vestibular function makes it useful in otorhinolaryngological surgeries[4].

Fentanyl Citrate

Fentanyl citrate is a highly potent opioid analgesic used to relieve severe pain during and after surgery. It is also used in palliative care for managing chronic pain, particularly through transdermal patches or continuous subcutaneous infusion (CSCI)[5].

Market Dynamics

Demand and Supply

The demand for both drugs is driven by their efficacy in pain management and sedation. However, the market is also influenced by regulatory and safety concerns. For instance, the use of fentanyl citrate has been scrutinized due to its role in the opioid crisis, leading to stricter prescribing guidelines and monitoring[2].

Competitive Landscape

The opioid market is highly competitive, with various opioids such as morphine, oxycodone, and methadone competing for market share. Fentanyl citrate, due to its potency and rapid onset, has a niche market in severe pain management. Droperidol, while less commonly used than fentanyl, maintains a presence in specific surgical and palliative care contexts[5].

Pricing and Accessibility

Fentanyl citrate, particularly in its transdermal form, is often more expensive than other opioids like morphine. However, its potency and the convenience of its delivery systems justify the higher cost. Droperidol, being less frequently prescribed, may have more variable pricing depending on the region and healthcare system[5].

Financial Trajectory

Revenue Trends

The revenue generated by fentanyl citrate has been significant due to its widespread use in surgical and palliative care settings. Despite the opioid crisis, fentanyl remains a crucial drug in pain management, contributing to stable revenue streams for pharmaceutical companies. Droperidol, while generating less revenue, maintains a steady market presence due to its specific medical applications[4].

Cost Considerations

The financial trajectory of these drugs is also influenced by the costs associated with their development, production, and distribution. The complexity of synthesizing fentanyl citrate and the stringent regulatory environment contribute to higher production costs. For droperidol, the costs are generally lower due to its longer market presence and established manufacturing processes.

Regulatory Environment

Safety Concerns and Warnings

Both drugs are subject to strict regulatory oversight due to their potential for serious side effects. Fentanyl citrate is known for its risk of respiratory depression, overdose, and contribution to the opioid epidemic. Droperidol has been associated with QT interval prolongation and serious arrhythmias, leading to black box warnings and cautious prescribing practices[1][2].

Impact on Market

Regulatory actions, such as the FDA's black box warnings for droperidol, can significantly impact the market dynamics. These warnings can reduce prescriptions and affect the financial performance of the drug. However, the critical need for these medications in specific medical contexts ensures they remain on the market, albeit with stricter guidelines.

Patient and Market Segmentation

Patient Profiles

Patients requiring droperidol and fentanyl citrate are typically those undergoing surgery, experiencing severe pain, or in palliative care. These patient segments are critical in driving demand, especially in hospitals and specialized care facilities.

Geographic Variations

The market for these drugs varies geographically, with different regions having different regulatory environments and healthcare systems. For example, the use of fentanyl citrate is more prevalent in the U.S. due to its high potency and the country's opioid crisis, while droperidol may be more commonly used in European countries with different prescribing practices.

Future Outlook

Innovations and Alternatives

The future market for droperidol and fentanyl citrate will be influenced by innovations in pain management and sedation. New drugs and delivery systems, such as extended-release formulations and alternative opioids, may challenge their market positions. However, their established roles in specific medical contexts ensure they will remain relevant.

Regulatory Changes

Future regulatory changes, particularly those aimed at mitigating the opioid crisis, will continue to shape the market. Stricter prescribing guidelines and increased monitoring are likely to impact the financial trajectory of these drugs.

Key Takeaways

  • Medical Use: Droperidol and fentanyl citrate are used in surgery, pain management, and palliative care due to their rapid onset and potent effects.
  • Market Dynamics: The market is influenced by regulatory concerns, safety warnings, and the competitive landscape of opioids.
  • Financial Trajectory: Revenue is stable for fentanyl citrate due to its widespread use, while droperidol generates less revenue but maintains a steady market presence.
  • Regulatory Environment: Strict oversight due to safety concerns impacts prescribing practices and market performance.
  • Future Outlook: Innovations in pain management and regulatory changes will continue to shape the market for these drugs.

FAQs

Q: What are the primary medical uses of droperidol and fentanyl citrate?

A: Droperidol is used for its antipsychotic and antiemetic properties, as well as in neuroleptanalgesia, while fentanyl citrate is used to relieve severe pain during and after surgery and in palliative care.

Q: What are the significant side effects associated with droperidol and fentanyl citrate?

A: Droperidol can cause QT interval prolongation and serious arrhythmias, while fentanyl citrate is associated with respiratory depression, overdose, and contribution to the opioid epidemic.

Q: How do regulatory changes impact the market for these drugs?

A: Regulatory changes, such as black box warnings and stricter prescribing guidelines, can reduce prescriptions and affect the financial performance of the drugs.

Q: What is the competitive landscape for droperidol and fentanyl citrate?

A: The opioid market is highly competitive, with various opioids competing for market share. Fentanyl citrate has a niche market in severe pain management, while droperidol maintains a presence in specific surgical and palliative care contexts.

Q: What is the future outlook for droperidol and fentanyl citrate in the market?

A: The future market will be influenced by innovations in pain management and regulatory changes aimed at mitigating the opioid crisis.

Sources

  1. Droperidol Injection USP - PDF.hres.ca
  2. Fentanyl (injection route) - Mayo Clinic
  3. The dynamics of US drug markets - Brookings Institution
  4. Droperidol-Fentanyl Citrate in Equilibratory Disturbances - JAMA Otolaryngology
  5. THE PALLIATIVE CARE HANDBOOK A Good Practice Guide - Ruh.nhs.uk

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