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Last Updated: December 22, 2024

COMPAZINE Drug Patent Profile


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When do Compazine patents expire, and what generic alternatives are available?

Compazine is a drug marketed by Glaxosmithkline and is included in seven NDAs.

The generic ingredient in COMPAZINE is prochlorperazine. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the prochlorperazine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Compazine

A generic version of COMPAZINE was approved as prochlorperazine by COSETTE on November 24th, 1993.

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Summary for COMPAZINE
US Patents:0
Applicants:1
NDAs:7
Raw Ingredient (Bulk) Api Vendors: 57
Clinical Trials: 21
DailyMed Link:COMPAZINE at DailyMed
Drug patent expirations by year for COMPAZINE
Recent Clinical Trials for COMPAZINE

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

SponsorPhase
Assertio Holdings, IncPhase 2
Washington University School of MedicinePhase 2
Dayton Children's HospitalN/A

See all COMPAZINE clinical trials

US Patents and Regulatory Information for COMPAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline COMPAZINE prochlorperazine maleate CAPSULE, EXTENDED RELEASE;ORAL 011000-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline COMPAZINE prochlorperazine edisylate CONCENTRATE;ORAL 011276-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline COMPAZINE prochlorperazine maleate CAPSULE, EXTENDED RELEASE;ORAL 021019-002 Oct 6, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline COMPAZINE prochlorperazine edisylate SYRUP;ORAL 011188-001 Approved Prior to Jan 1, 1982 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

COMPAZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prochlorperazine (Compazine)

Introduction

Prochlorperazine, commonly known by the brand name Compazine, is a medication belonging to the phenothiazine class of antipsychotic drugs. It is widely used for managing severe nausea and vomiting, vertigo, and various mental health disorders. Here, we delve into the market dynamics and financial trajectory of prochlorperazine, highlighting key drivers, challenges, and future projections.

Market Size and Growth

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

Key Drivers

Increasing Prevalence of Mental Health Disorders

The rising prevalence of mental health disorders such as schizophrenia, anxiety, and other psychiatric conditions is a significant driver for the market. According to the World Health Organization (WHO), schizophrenia affects approximately 24 million people worldwide, with a higher prevalence among adults[4].

Growing Demand for Antiemetic Treatments

Prochlorperazine is highly effective in controlling nausea and vomiting associated with chemotherapy, postoperative procedures, and other medical conditions. The increasing number of cancer survivors, projected to rise by 24.4% to 22.5 million by 2032, will further drive the demand for prochlorperazine to manage symptoms of cancer therapy[4].

Flexibility in Administration

The drug is available in various forms, including oral tablets, rectal suppositories, and injectable formulations, which provides flexibility in administration and caters to different patient needs[1].

Market Segments

By Formulation

The market is segmented based on the formulation of prochlorperazine, with oral tablets being the most common form. However, the demand for injectable and rectal suppository forms is also significant, particularly in clinical settings where rapid administration is necessary[1].

By Application

Prochlorperazine is used in various applications, including the management of severe nausea and vomiting, vertigo, and mental health disorders such as schizophrenia. The increasing awareness about mental health and the availability of effective treatments are contributing to market growth[1].

Geographical Analysis

The global prochlorperazine maleate market is geographically diverse, with significant markets in North America, Europe, Asia-Pacific, and other regions. The market growth in these regions is driven by the increasing prevalence of mental health disorders and the growing need for effective antiemetic treatments[1].

Key Players

The market is dominated by several key players, including Sandoz Inc., Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Glenmark Pharmaceuticals Inc., and Teva Pharmaceutical Industries Ltd. These companies are investing in research and development to enhance the efficacy and safety of prochlorperazine formulations[1].

Financial Performance

Revenue Projections

The projected growth of the prochlorperazine maleate market from US$ 1.46 billion in 2023 to US$ 1.85 billion by 2030 indicates a stable financial trajectory. This growth is driven by the increasing demand for the drug across various therapeutic applications[1].

Capital Investments and Funding

Companies involved in the production and distribution of prochlorperazine are making significant capital investments to expand their manufacturing capacities and improve their product portfolios. For instance, investments in new formulations and delivery systems, such as precision timed release technologies, are expected to enhance market competitiveness[4].

Challenges and Restraints

Regulatory Environment

The pharmaceutical industry, including the prochlorperazine market, is heavily regulated. Changes in regulatory policies, such as those related to pricing and approval processes, can impact market dynamics. For example, the Inflation Reduction Act in the U.S. allows Medicare to set prices for certain drugs, which could affect the profitability of pharmaceutical companies[3].

Generic and Biosimilar Competition

The entry of generic and biosimilar versions of prochlorperazine can reduce the market share of branded products. This competition can lead to price reductions and affect the revenue of key players in the market[3].

Future Outlook

Increasing Investments in Research and Development

Companies are focusing on research and development to improve the efficacy and safety of prochlorperazine. Innovations in drug delivery systems, such as the Precision Timed Release™ (PTR™) technology by Cingulate Inc., are expected to enhance patient compliance and treatment outcomes[2].

Growing Awareness and Demand

The rising awareness about mental health and the increasing prevalence of conditions requiring antiemetic treatments will continue to drive the demand for prochlorperazine. This trend is expected to sustain the market growth over the forecast period[1].

Key Takeaways

  • The global prochlorperazine maleate market is projected to grow from US$ 1.46 billion in 2023 to US$ 1.85 billion by 2030.
  • Key drivers include the increasing prevalence of mental health disorders and the growing demand for antiemetic treatments.
  • The market is segmented by formulation and application, with oral tablets being the most common form.
  • Major players are investing in research and development to enhance product efficacy and safety.
  • Regulatory changes and generic competition are significant challenges for the market.

FAQs

What is the primary use of prochlorperazine maleate?

Prochlorperazine maleate is primarily used for the management of severe nausea and vomiting, vertigo, and certain mental health disorders such as schizophrenia.

Which regions are significant for the prochlorperazine maleate market?

The market is geographically diverse, with significant markets in North America, Europe, Asia-Pacific, and other regions.

What are the key drivers for the prochlorperazine maleate market?

The key drivers include the increasing prevalence of mental health disorders and the growing demand for antiemetic treatments associated with chemotherapy and other medical conditions.

Who are the major players in the prochlorperazine maleate market?

Major players include Sandoz Inc., Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Glenmark Pharmaceuticals Inc., and Teva Pharmaceutical Industries Ltd.

What are the challenges faced by the prochlorperazine maleate market?

Challenges include regulatory changes, generic and biosimilar competition, and the need for continuous innovation in drug delivery systems.

Sources

  1. Coherent Market Insights: Prochlorperazine Maleate Market Size and Forecast to 2030.
  2. Cingulate Inc.: Cingulate Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update.
  3. Genetic Engineering and Biotechnology News: Top 10 Best Selling Drugs.
  4. IMARC Group: Prochlorperazine (Compazine) Manufacturing Plant Project Report.

More… ↓

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