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 Pharma Ltd, 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:	35
Patent Applications:	521
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
Marsam Pharms Llc	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	089675-001	Dec 5, 1988		DISCN	No	No
Hospira	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	089703-001	Apr 7, 1988		DISCN	No	No
Glaxosmithkline	COMPAZINE	prochlorperazine edisylate	INJECTABLE;INJECTION	010742-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Parenteral	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	040505-001	May 30, 2003		DISCN	No	No
Hikma	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	213630-001	Nov 22, 2022		DISCN	No	No
Wyeth Ayerst	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	086348-001	Approved Prior to Jan 1, 1982		DISCN	No	No

PROCHLORPERAZINE EDISYLATE Market Analysis and Financial Projection Experimental

Prochlorperazine Maleate and Prochlorperazine Edisylate Market Dynamics and Financial Trajectory

Market Overview

The market for prochlorperazine, including its edisylate form, is poised for steady growth driven by its established efficacy and widespread use in managing nausea and vomiting. Here are the key dynamics and financial projections for this market.

Market Size and Growth

The global prochlorperazine maleate market is estimated to be valued at US$ 1.46 billion in 2023 and is expected to reach US$ 1.85 billion by 2030, growing at a compound annual growth rate (CAGR) of 3.4% from 2023 to 2030[1].

Market Trends

Increasing Demand in Medical Specialties

Prochlorperazine's versatility in treating multiple conditions, including those in oncology, gastroenterology, and neurology, contributes significantly to its demand. The drug is particularly valuable in managing nausea and vomiting associated with chemotherapy and radiation therapy, which is becoming more prevalent due to the increasing number of cancer survivors[2].

Expanding Therapeutic Indications

Ongoing research and development efforts aim to enhance the drug's formulation, improve patient compliance, and explore new therapeutic indications. This continuous innovation is expected to further expand the market potential for prochlorperazine[1].

Occupational Health Applications

Prochlorperazine is also used in occupational health programs to treat symptoms and preserve productivity in jobs where workers are subjected to situations that could cause nausea or vomiting, such as handling hazardous materials or working in excessive motion[2].

Distribution Channels and End Users

The market is segmented by dosage form, distribution channel, and end user. Key segments include:

• Dosage Forms: Oral tablets, rectal suppositories, and injectable formulations[3].
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies[3].
• End Users: Hospitals, clinics, ambulatory surgical centers, and homecare settings[3].

Regional Outlook

The prochlorperazine maleate market is evaluated region-wise, with different regions showing varying growth rates. The report provides insights into the market dynamics, trends, and opportunities in each region, helping market participants make informed decisions[3].

Financial Analysis

Capital Expenditure (CapEx) and Operational Expenditure (OpEx)

Setting up a prochlorperazine manufacturing plant involves significant capital and operational expenditures. The project report provides a detailed analysis of CapEx, OpEx, income projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, net present value (NPV), and sensitivity analysis. This comprehensive financial analysis is crucial for investors and manufacturers to understand the economic viability of the project[2].

Profitability Analysis

The profitability of prochlorperazine manufacturing is influenced by several factors, including raw material costs, machinery and technology requirements, manpower, packaging, transportation, and utility costs. The report provides a detailed profitability analysis, including fixed and variable costs, direct and indirect costs, and expected return on investment (ROI)[2].

Regulatory Framework

The market is also influenced by regulatory frameworks across different regions. The report covers regulatory procedures and approvals, financial assistance, and certifications required for setting up a prochlorperazine manufacturing plant. Compliance with these regulations is essential for market participants to ensure smooth operations and avoid legal complications[2].

Competitive Landscape

The prochlorperazine maleate market is competitive, with several key players such as Sandoz Inc., Mylan Pharmaceuticals Inc., and Amneal Pharmaceuticals LLC. Recent collaborations, mergers, acquisitions, and partnerships are shaping the market trajectory. Understanding the competitive landscape is crucial for market participants to increase their competitiveness and market share[3].

Technological Advances and Innovations

Recent technological advances and innovations are influencing the prochlorperazine maleate market. For instance, the launch of new formulations and delivery systems, such as the launch of Prochlorperazine Maleate Tablets USP by ANI Pharmaceuticals, Inc. in 2022, are enhancing patient compliance and expanding market potential[1].

Market Drivers and Restraints

Drivers

• Established Efficacy: Prochlorperazine's proven efficacy in managing nausea and vomiting drives its demand.
• Increasing Cancer Survivors: The growing number of cancer survivors and the need for effective antiemetic treatments during chemotherapy and radiation therapy are significant drivers[2].
• Occupational Health: The use of prochlorperazine in occupational health programs to maintain worker productivity is another driver[2].

Restraints

• Side Effects: Prochlorperazine can have side effects such as extrapyramidal signs, hyperreflexia, or hyporeflexia in newborn infants whose mothers received the drug during pregnancy. These risks can limit its use in certain patient populations[5].
• Regulatory Compliance: Strict regulatory requirements and the need for continuous compliance can be a restraint for new entrants in the market[2].

Key Takeaways

• The global prochlorperazine maleate market is expected to grow from US$ 1.46 billion in 2023 to US$ 1.85 billion by 2030.
• The market is driven by its established efficacy, increasing demand in medical specialties, and expanding therapeutic indications.
• Key segments include oral tablets, rectal suppositories, and injectable formulations, distributed through hospital pharmacies, retail pharmacies, and online pharmacies.
• Regulatory compliance and technological innovations are crucial for market growth.
• The market faces restraints such as side effects and regulatory challenges.

FAQs

Q1: What is the projected growth rate of the prochlorperazine maleate market from 2023 to 2030?

The prochlorperazine maleate market is expected to grow at a CAGR of 3.4% from 2023 to 2030[1].

Q2: Which medical specialties drive the demand for prochlorperazine?

The demand for prochlorperazine is driven by its use in oncology, gastroenterology, and neurology[1].

Q3: What are the key distribution channels for prochlorperazine maleate?

The key distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies[3].

Q4: What are the potential side effects of prochlorperazine edisylate?

Prochlorperazine edisylate can have side effects such as extrapyramidal signs, hyperreflexia, or hyporeflexia in newborn infants whose mothers received the drug during pregnancy[5].

Q5: How does the increasing number of cancer survivors impact the prochlorperazine maleate market?

The growing number of cancer survivors increases the demand for effective antiemetic treatments during chemotherapy and radiation therapy, driving the market for prochlorperazine maleate[2].

Sources

1. Coherent Market Insights - Prochlorperazine Maleate Market Size and Trends
2. IMARC Group - Prochlorperazine (Compazine) Manufacturing Plant Project Report
3. OpenPR - Prochlorperazine Maleate Market Overview, Analysis, Growth
4. Market Research Intellect - Global Prochlorperazine Maleate Market Size, Trends and Projections
5. FDA - Prochlorperazine Label