PROCHLORPERAZINE EDISYLATE - Generic Drug Details

What are the generic sources for prochlorperazine edisylate and what is the scope of freedom to operate?

Prochlorperazine edisylate is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Alpharma Us Pharms, Morton Grove, Baxter Hlthcare, Amneal, Avet Lifesciences, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Marsam Pharms Llc, Mylan Labs Ltd, Nexus, Sagent, Smith And Nephew, Somerset Theraps Llc, Teva Parenteral, Viwit Pharm, Watson Labs, and Wyeth Ayerst, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for prochlorperazine edisylate. Seventeen suppliers are listed for this compound.

Summary for PROCHLORPERAZINE EDISYLATE

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	29
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	40
What excipients (inactive ingredients) are in PROCHLORPERAZINE EDISYLATE?	PROCHLORPERAZINE EDISYLATE excipients list
DailyMed Link:	PROCHLORPERAZINE EDISYLATE at DailyMed

Pharmacology for PROCHLORPERAZINE EDISYLATE

Drug Class

Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for PROCHLORPERAZINE EDISYLATE

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for PROCHLORPERAZINE EDISYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Caplin	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	214379-001	Apr 22, 2021	AP	RX	No	No
Eugia Pharma	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	213873-001	Jul 14, 2022	AP	RX	No	No
Avet Lifesciences	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	204147-001	Oct 15, 2013	AP	RX	No	Yes
Amneal	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	214192-001	Nov 28, 2022	AP	RX	No	No

Market Dynamics and Financial Trajectory for Prochlorperazine Edisylate

Last updated: July 28, 2025

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Introduction

Prochlorperazine edisylate, a potent phenothiazine derivative, primarily functions as an antiemetic and antipsychotic medication. Initially approved decades ago, it remains in use for nausea, vertigo, and schizophrenia. Despite its longstanding presence, the drug’s market dynamics and financial trajectory are subject to evolving medical guidelines, regulatory landscapes, competitive pressures, and patent statuses. This report offers a comprehensive analysis for industry stakeholders seeking insight into prochlorperazine edisylate's current and projected market positioning.

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Pharmacological Profile and Clinical Applications

Prochlorperazine edisylate operates by antagonizing dopamine receptors, notably D2 receptors, in the central nervous system. Its efficacy spans multiple indications, including nausea and vomiting management, severe agitation, and psychosis. Key features include:

• Formulations: Oral tablets, suppositories, injectable forms.
• Typical Use Cases: Motion sickness, postoperative nausea, psychiatric disorders.
• Safety Profile: Risks include extrapyramidal symptoms, sedation, and QT interval prolongation, which influence prescribing behaviors.

The drug's versatility ensures ongoing relevance, but safety concerns and newer agents influence its clinical adoption.

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Market Dynamics Overview

1. Regulatory Environment

Historically, prochlorperazine has benefited from a broad regulatory approval spectrum, with widespread off-label use. However, safety signals concerning extrapyramidal side effects and cardiac risks have prompted increased regulatory scrutiny. Agencies like the FDA have issued warnings, potentially restraining aggressive marketing and influencing prescriber preferences.

2. Competitive Landscape

The antiemetic and antipsychotic markets are highly competitive, dominated by newer, targeted agents:

• Nausea & Vomiting: Ondansetron (5-HT3 antagonists), promethazine, and newer neurokinin receptor antagonists have encroached on traditional prochlorperazine indications.
• Psychosis: Second-generation antipsychotics like risperidone and olanzapine offer improved side effect profiles, reducing reliance on phenothiazines.

This increased competition impacts market share and pricing power for prochlorperazine edisylate.

3. Patent and Market Exclusivity

Prochlorperazine's patent expired decades ago, exposing it to generic manufacturing worldwide. Generic competition has driven down prices, especially in mature markets, diminishing profit margins and reducing incentive for continued R&D investment.

4. Prescriber Preferences and Clinical Guidelines

Guidelines increasingly favor agents with better safety profiles. For example, the American Society of Clinical Oncology recommends ondansetron as first-line for chemotherapy-induced nausea. This trend suppresses the growth potential of older drugs like prochlorperazine.

5. Manufacturing and Supply Chain Factors

Prochlorperazine’s manufacturing remains stable, but disruptions in raw materials or regulatory compliance costs can influence pricing and availability, especially with tightening quality control protocols.

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Financial Trajectory Analysis

Historical Performance

• Market Volume: The global antiemetic market was valued at approximately USD 2.4 billion in 2020, with phenothiazines accounting for a modest segment due to off-label and generic uses [1].
• Pricing Trends: Generic pricing dominance has resulted in substantial price erosion; in mature markets, unit prices decrease by approximately 10-15% annually, correlating with increased competition.

Projected Growth and Decline

• Short-term Outlook (1-3 Years): Demand remains steady in niche segments such as emergency medicine and niche psychiatric indications. However, growth is constrained by safety concerns and shifting guidelines.
• Medium to Long-term Outlook (3-10 Years): Market decline is anticipated, driven by replacement with safer, more targeted agents. The sluggish pipeline for phenothiazine derivatives implies limited reintroduction or reformulation prospects.

Emerging Trends Impacting Financial Trajectory

• Generic Market Saturation: Saturation limits revenue growth; price erosion continues.
• Regulatory Pressures: Potential restrictions on use may decrease market size further.
• New Indications and Formulations: Limited innovative attempts due to safety concerns and patent expiry.
• Geographical Variability: Emerging markets may maintain some demand due to cost advantages; however, safety and regulatory standards vary.

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Future Outlook and Investment Implications

Given the current landscape, investments in prochlorperazine edisylate are unlikely to yield significant growth. Revenue streams will primarily derive from existing generic sales, with minimal capacity for expansion absent major repositioning or new formulations. Industry players focusing on alternative antiemetics or antipsychotics with improved safety profiles are better positioned for long-term profitability.

In essence, the financial trajectory indicates a gradual decline in market relevance, amplified by regulatory, safety, and competitive factors. While stable in certain applications, prochlorperazine edisylate's future as a revenue-generating drug appears limited without innovative repositioning.

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Conclusion

Prochlorperazine edisylate's market dynamics are characterized by mature, saturated markets, robust generic competition, and a shift in clinical preference toward newer agents. Financial trends reflect declining revenues, constrained by safety concerns and regulatory scrutiny, with limited prospects for meaningful growth. Companies and investors should regard prochlorperazine as a legacy asset with diminishing strategic value, focusing instead on innovative drugs with more favorable safety profiles and market potential.

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Key Takeaways

• Market saturation and dispelling safety concerns suppress future revenue growth for prochlorperazine edisylate.
• The expiration of patents and aggressive generics competition drive prices downward, limiting profit margins.
• Clinical guidelines increasingly favor newer, safer antiemetics and antipsychotics, reducing prescription volumes.
• Regulatory and safety challenges hinder opportunities for reformulation or novel indications.
• Strategic focus should shift toward newer therapeutic agents with clearer growth trajectories and improved safety profiles.

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FAQs

1. Is prochlorperazine edisylate still a viable treatment option?
Yes, it remains in use for specific indications such as refractory nausea and certain psychiatric conditions, especially where newer agents are contraindicated or unavailable. However, its role is diminishing due to safety concerns and newer therapies.

2. How does patent expiry affect the financial prospects of prochlorperazine edisylate?
Patent expiry introduces generic competition, substantially lowering prices and revenue potential, thereby reducing profitability and investment incentives.

3. Are there ongoing efforts to reformulate or develop safer versions of prochlorperazine?
Currently, no significant pipeline exists for reformulating phenothiazine derivatives due to safety issues and the availability of better alternatives.

4. How do regulatory agencies impact the market for older psychiatric drugs like prochlorperazine?
Regulatory agencies influence market access by issuing safety warnings, restricting indications, or requiring additional labeling, which can limit prescribing and reduce sales.

5. What are the main competitors to prochlorperazine in its primary indications?
Ondansetron, promethazine, and newer neurokinin receptor antagonists dominate the antiemetic market, while second-generation antipsychotics have largely replaced phenothiazines in psychiatric care.

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References

[1] Research and Markets. "Global Anti-Emetics Market Analysis," 2021.