DROPERIDOL - Generic Drug Details

What are the generic drug sources for droperidol and what is the scope of freedom to operate?

Droperidol is the generic ingredient in four branded drugs marketed by Abraxis Pharm, Am Regent, Astrazeneca, Hikma, Hospira, Igi Labs Inc, Luitpold, Smith And Nephew, Solopak, Watson Labs, Rising, and Epic Pharma Llc, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for droperidol. Two suppliers are listed for this compound.

Summary for DROPERIDOL

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	24
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	43
Patent Applications:	6,673
What excipients (inactive ingredients) are in DROPERIDOL?	DROPERIDOL excipients list
DailyMed Link:	DROPERIDOL at DailyMed

Recent Clinical Trials for DROPERIDOL

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

Sponsor	Phase
RenJi Hospital	N/A
Lake Erie College of Osteopathic Medicine	Phase 3
Mercy Health Ohio	Phase 3

See all DROPERIDOL clinical trials

Pharmacology for DROPERIDOL

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for DROPERIDOL

Adjuvants, Anesthesia

Antiemetics

Antipsychotic Agents

Dopamine D2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DROPERIDOL

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for DROPERIDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Solopak	DROPERIDOL	droperidol	INJECTABLE;INJECTION	071755-001	Sep 6, 1988		DISCN	No	No
Solopak	DROPERIDOL	droperidol	INJECTABLE;INJECTION	071754-001	Sep 6, 1988		DISCN	No	No
Astrazeneca	DROPERIDOL	droperidol	INJECTABLE;INJECTION	072018-001	Oct 20, 1988		DISCN	No	No
Astrazeneca	FENTANYL CITRATE AND DROPERIDOL	droperidol; fentanyl citrate	INJECTABLE;INJECTION	072027-001	Apr 13, 1989		DISCN	No	No

DROPERIDOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Droperidol

Introduction

Droperidol, a butyrophenone derivative, has been a significant player in the pharmaceutical market, particularly in the emergency department and surgical settings, due to its efficacy in reducing nausea and vomiting and managing agitation. Here, we delve into the market dynamics and financial trajectory of droperidol, highlighting its current status, challenges, and future prospects.

Historical Context and Regulatory Environment

Droperidol has faced significant regulatory scrutiny, particularly with the FDA's black box warning issued due to concerns over adverse cardiac events. However, subsequent studies have shown that at low doses (less than 2.5 mg), the risk of these events is minimal, and the FDA has since conceded that the black box warning does not apply at these doses[3].

Market Size and Growth

The global droperidol market has experienced growth, although the exact figures vary. From 2014 to 2019, the market witnessed a compound annual growth rate (CAGR) that indicated a steady expansion. The market size is estimated to continue growing from 2019 to 2031, driven by increasing demand for effective antiemetic and antipsychotic treatments[1][4].

Clinical Applications and Efficacy

Droperidol is widely used in emergency departments for treating nausea, vomiting, headaches, and acute agitation. Studies have consistently shown its safety and efficacy at doses up to 10 mg IV or IM, with minimal adverse cardiac events when properly monitored[3].

• Nausea and Vomiting: Droperidol has been found to be more effective than metoclopramide or prochlorperazine in reducing symptoms of nausea and vomiting in ED patients[3].
• Headaches: It is superior to prochlorperazine for migraine control and benign headaches[3].
• Agitation: Droperidol is effective for sedation of acutely agitated patients, often used in combination with midazolam without inducing dysrhythmias or QTc changes[3].

Financial Performance of Key Players

Companies like Eagle Pharmaceuticals, which do not specifically focus on droperidol but operate in related therapeutic areas, provide insights into the broader pharmaceutical market dynamics.

• Eagle Pharmaceuticals: While not directly involved in the droperidol market, Eagle's financial performance indicates the overall health of the pharmaceutical sector. In Q2 2023, Eagle reported total revenue of $64.6 million, with a net income of $5.2 million and adjusted non-GAAP EBITDA of $20.7 million. The company's success in oncology and hospital business segments suggests a robust market environment for pharmaceuticals[2][5].

Market Challenges

Despite its clinical efficacy, droperidol faces several challenges:

• Regulatory Hurdles: The initial black box warning, although later mitigated, has had a lasting impact on its usage and perception.
• Competition: Other antiemetic and antipsychotic drugs, such as metoclopramide and prochlorperazine, compete with droperidol for market share.
• Monitoring Requirements: High-dose administration requires cardiac monitoring, which can be a logistical challenge in some settings[3].

Future Prospects

The future of droperidol looks promising due to several factors:

• Continued Clinical Validation: Ongoing studies and reviews continue to validate the safety and efficacy of droperidol, particularly at low doses.
• Market Demand: The increasing need for effective treatments in emergency and surgical settings drives demand for droperidol.
• Regulatory Clarifications: The FDA's acknowledgment that the black box warning does not apply at doses less than 2.5 mg has helped in reinstating confidence in the drug[3].

Financial Trajectory

The financial trajectory for droperidol is tied to the broader pharmaceutical market trends and the specific demand for antiemetic and antipsychotic treatments.

• Revenue Growth: The global droperidol market is expected to grow, driven by increasing demand and the expanding healthcare sector.
• Cost and Pricing: The cost of production and pricing strategies will play a crucial role in determining the financial performance of companies involved in the droperidol market.
• Research and Development: Continued investment in R&D to enhance the drug's profile and address any remaining safety concerns will be essential for long-term financial success[1][4].

Key Takeaways

• Droperidol remains a valuable drug in emergency and surgical settings due to its efficacy in treating nausea, vomiting, and agitation.
• Regulatory challenges have been largely mitigated, and the drug is considered safe at low doses.
• The market is expected to grow, driven by increasing demand and clinical validation.
• Companies operating in related therapeutic areas show robust financial performance, indicating a healthy market environment.

FAQs

Q: What is the primary indication for droperidol? A: The primary indication for droperidol is reducing the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

Q: Why did droperidol receive a black box warning from the FDA? A: Droperidol received a black box warning due to concerns over adverse cardiac events, but subsequent studies have shown that at low doses (less than 2.5 mg), the risk is minimal.

Q: How effective is droperidol compared to other antiemetic drugs? A: Droperidol has been found to be more effective than metoclopramide or prochlorperazine in reducing symptoms of nausea and vomiting in ED patients.

Q: What are the common doses of droperidol used in clinical settings? A: Common doses range from 1.25 mg IV to 10 mg IV or IM, depending on the condition being treated.

Q: What is the current market outlook for droperidol? A: The market is expected to grow, driven by increasing demand and the expanding healthcare sector, with a positive financial trajectory anticipated.

Sources

1. Global Droperidol Injection Market Report 2024 Edition - Cognitivemarketresearch.com
2. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Globenewswire.com
3. Use of Droperidol in the Emergency Department - ACEP.org
4. Global Droperidol Market Report 2019 - Kenresearch.com
5. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Investor.eagleus.com