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Last Updated: December 22, 2024

Fospropofol disodium - Generic Drug Details


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What are the generic sources for fospropofol disodium and what is the scope of patent protection?

Fospropofol disodium is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for fospropofol disodium
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 20
Patent Applications: 10
DailyMed Link:fospropofol disodium at DailyMed
Recent Clinical Trials for fospropofol disodium

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

SponsorPhase
Xiaobo Yang, MDPhase 2
Wuhan Union Hospital, ChinaPhase 2
Mayo ClinicPhase 4

See all fospropofol disodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fospropofol disodium

US Patents and Regulatory Information for fospropofol disodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc LUSEDRA fospropofol disodium SOLUTION;INTRAVENOUS 022244-001 Dec 12, 2008 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

Fospropofol disodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fospropofol Disodium

Introduction

Fospropofol disodium, a prodrug of propofol, has been gaining traction in the anesthesia drugs market due to its unique properties and clinical benefits. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The global anesthesia drugs market, which includes fospropofol disodium, is projected to grow significantly. The United States, in particular, is a prominent regional market driven by factors such as an increasing geriatric population, rising incidence of cardiovascular cases, and a higher number of urgent surgeries[3].

Growth Drivers

Several factors are driving the growth of the fospropofol disodium market:

Increasing Demand for Anesthesia Drugs

The demand for anesthesia drugs is rising due to the growing number of surgical procedures. Fospropofol disodium, with its efficacy in general anesthesia and monitored anesthesia care (MAC) sedation, is well-positioned to meet this demand[3].

Clinical Benefits

Fospropofol disodium offers several clinical benefits, including a reduced incidence of pain at the site of injection and a general anesthesia effect comparable to propofol. These advantages make it a preferred choice among anesthesiologists[2].

Regulatory Approval

The FDA approval of fospropofol disodium in 2008 marked a significant milestone. This approval under Section 505(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) has facilitated its commercial marketing and use in the United States[5].

Market Size and Forecast

The global fospropofol disodium market is expected to reach USD 450 million by 2026, growing at a Compound Annual Growth Rate (CAGR) of 7.2% during the forecast period. This growth is driven by the increasing adoption of fospropofol disodium in various medical procedures[4].

Competitive Landscape

The anesthesia drugs market is competitive, with several major players such as Baxter International Inc., Abbvie, Endo International plc, Draegerwerk AG, and Koninklijke Philips NV. Fospropofol disodium, marketed under the brand name LUSEDRA, competes with other general intravenous anesthesia drugs like propofol, benzodiazepines, ketamine, and fentanyl[3].

Segment Analysis

General Intravenous Anesthesia Drugs

Fospropofol disodium falls under the general intravenous anesthesia drugs segment, which is a leading segment in the United States anesthesia drugs market. This segment includes other drugs like propofol, benzodiazepines, ketamine, and fentanyl, but fospropofol disodium's unique properties, such as water solubility and reduced injection site pain, give it a competitive edge[3].

Financial Performance

The financial performance of fospropofol disodium is closely tied to the overall growth of the anesthesia drugs market. Here are some key financial indicators:

Revenue Growth

The revenue from fospropofol disodium is expected to increase as the drug gains more acceptance and usage in clinical settings. The projected market size of USD 450 million by 2026 indicates a robust financial trajectory[4].

Market Share

While fospropofol disodium is not the leading drug in the general intravenous anesthesia segment, it is gaining market share due to its clinical benefits and FDA approval. The market share is expected to increase as more healthcare providers adopt this drug[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the anesthesia drugs market, including fospropofol disodium. Supply chain disruptions, reduced demand due to fewer elective surgeries, and challenges in delivering products to end-users affected the market. However, as healthcare systems recover, the demand for anesthesia drugs, including fospropofol disodium, is expected to rebound[3].

Challenges

Despite the growth potential, the fospropofol disodium market faces several challenges:

Adverse Events

While fospropofol disodium is generally safe, it can cause adverse events such as abnormal feeling, blood pressure reduction, and injection site pain. These side effects need to be carefully managed by healthcare providers[2].

Competition

The market is highly competitive, with established drugs like propofol and benzodiazepines. Fospropofol disodium must continue to demonstrate its unique benefits to maintain and increase its market share[3].

Future Outlook

The future outlook for fospropofol disodium is positive, driven by its clinical efficacy, regulatory approval, and growing demand for anesthesia drugs. As the global healthcare landscape continues to evolve, fospropofol disodium is poised to play a significant role in the anesthesia drugs market.

"Fospropofol FD (20 mg/kg) is not inferior to propofol-MCT/LCT (2 mg/kg) in general anesthesia induction for American Society of Anesthesiologists (ASA) physical status I-II adult patients undergoing elective surgeries. It is safe and effective for clinical use under anesthesiologist monitoring."[2]

Key Takeaways

  • Market Growth: The global fospropofol disodium market is projected to reach USD 450 million by 2026, growing at a CAGR of 7.2%.
  • Clinical Benefits: Fospropofol disodium reduces pain at the site of injection and offers a general anesthesia effect comparable to propofol.
  • Regulatory Approval: FDA-approved under Section 505(b) of the FFDCA in 2008.
  • Competitive Landscape: Competes with other general intravenous anesthesia drugs in a highly competitive market.
  • Financial Performance: Expected to increase revenue as it gains more clinical acceptance.

FAQs

What is fospropofol disodium?

Fospropofol disodium is a prodrug of propofol, used for general anesthesia and monitored anesthesia care (MAC) sedation. It is metabolized into the active metabolite propofol by endogenous alkaline phosphatases[5].

What are the clinical benefits of fospropofol disodium?

Fospropofol disodium reduces the incidence of pain at the site of injection and provides a general anesthesia effect comparable to propofol. It is safe and effective for clinical use under anesthesiologist monitoring[2].

What is the market size and forecast for fospropofol disodium?

The global fospropofol disodium market is expected to reach USD 450 million by 2026, growing at a CAGR of 7.2% during the forecast period[4].

Who are the major players in the anesthesia drugs market?

Major players include Baxter International Inc., Abbvie, Endo International plc, Draegerwerk AG, and Koninklijke Philips NV[3].

How did the COVID-19 pandemic impact the fospropofol disodium market?

The COVID-19 pandemic caused supply chain disruptions, reduced demand due to fewer elective surgeries, and challenges in delivering products to end-users, affecting the market. However, the demand is expected to rebound as healthcare systems recover[3].

What are the common adverse events associated with fospropofol disodium?

Common adverse events include abnormal feeling, blood pressure reduction, and injection site pain[2].

Sources

  1. Market Research Reports: Global Fospropofol Disodium Market Growth 2024-2030.
  2. Frontiers in Pharmacology: Efficacy and Safety of Fospropofol Disodium for Injection in General Anesthesia.
  3. PR Newswire: United States Anesthesia Drugs Markets, 2022-2027.
  4. Data Horizzon Research: Fospropofol Disodium Market Size, Share, Growth, Statistics Report.
  5. Regulations.gov: Docket No. FDA-2009-E-0204-0001.

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