PROCHLORPERAZINE MALEATE - Generic Drug Details

What are the generic sources for prochlorperazine maleate and what is the scope of patent protection?

Prochlorperazine maleate is the generic ingredient in four branded drugs marketed by Glaxosmithkline, Watson Labs, Ajanta Pharma Ltd, Amneal, Bionpharma, Chartwell Rx, Duramed Pharms Barr, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Leading, Norvium Bioscience, Novitium Pharma, Teva Pharms, Zydus Lifesciences, and Jubilant Cadista, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for prochlorperazine maleate. Twenty-eight suppliers are listed for this compound.

Summary for PROCHLORPERAZINE MALEATE

US Patents:	0
Tradenames:	4
Applicants:	15
NDAs:	22
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	125
Patent Applications:	6,811
Drug Prices:	Drug price trends for PROCHLORPERAZINE MALEATE
Drug Sales Revenues:	Drug sales revenues for PROCHLORPERAZINE MALEATE
What excipients (inactive ingredients) are in PROCHLORPERAZINE MALEATE?	PROCHLORPERAZINE MALEATE excipients list
DailyMed Link:	PROCHLORPERAZINE MALEATE at DailyMed

See drug prices for PROCHLORPERAZINE MALEATE

See drug sales revenues for PROCHLORPERAZINE MALEATE

Pharmacology for PROCHLORPERAZINE MALEATE

Drug Class

Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for PROCHLORPERAZINE MALEATE

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 MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	216598-001	Apr 17, 2023	AB	RX	No	No
Ajanta Pharma Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218515-002	May 9, 2024	AB	RX	No	No
Glaxosmithkline	COMPAZINE	prochlorperazine maleate	CAPSULE, EXTENDED RELEASE;ORAL	021019-002	Oct 6, 1999		DISCN	No	No
Chartwell Rx	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	040101-003	Jul 19, 1996		DISCN	No	No
Ajanta Pharma Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218515-001	May 9, 2024	AB	RX	No	No
Jubilant Cadista	PROCOMP	prochlorperazine maleate	TABLET;ORAL	040268-002	Feb 27, 1998	AB	RX	No	Yes

PROCHLORPERAZINE MALEATE Market Analysis and Financial Projection Experimental

Prochlorperazine Maleate Market Dynamics and Financial Trajectory

Market Size and Forecast

The global Prochlorperazine Maleate Market has been experiencing significant growth and is projected to continue this trend in the coming years. As of 2023, the market size was valued at approximately USD 1.46 billion and is expected to reach USD 1.85 billion by 2030, growing at a compound annual growth rate (CAGR) of 3.4% from 2023 to 2030[3][5].

Segmentation and Key Contributors

The Prochlorperazine Maleate Market is segmented based on several key factors:

By Indication

The market is primarily driven by the management of severe nausea and vomiting, particularly in cases such as chemotherapy-induced nausea and vomiting (CINV). Other significant indications include vertigo and mental health disorders like schizophrenia[2][3][5].

By Dosage Form

Prochlorperazine maleate is available in various forms, including oral tablets, rectal suppositories, and injectable formulations, which cater to different patient needs and preferences[2][5].

By Distribution Channel

The distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, each playing a crucial role in the market's growth[2].

By End-User

The end-users of prochlorperazine maleate include hospitals, clinics, ambulatory surgical centers, and homecare settings. The clinics segment is expected to grow rapidly due to the increasing focus on patient-centered care[2].

Geographical Insights

The North American region holds a significant revenue share in the global Prochlorperazine Maleate Market, driven by a sophisticated healthcare infrastructure, a well-established pharmaceutical sector, and a high prevalence of antiemetic disorders. Europe is also a major market for prochlorperazine maleate[2][5].

Market Drivers

Several factors are driving the growth of the Prochlorperazine Maleate Market:

Established Efficacy

Prochlorperazine maleate's proven efficacy in controlling nausea and vomiting, especially in chemotherapy and postoperative procedures, is a major driver. Its versatility in treating multiple conditions across various medical specialties, such as oncology, gastroenterology, and neurology, further contributes to its demand[2][3][5].

Rising Chronic Disease Prevalence

The increasing prevalence of chronic diseases and an aging population are leading to a higher demand for antiemetic therapies, thereby fueling market growth[3][5].

Patient Awareness and Preferences

Growing patient awareness and the desire for effective treatment options are driving the market. Patients are more proactive in seeking appropriate therapies and discussing their issues with healthcare providers, which is leading to increased adoption of prochlorperazine maleate[3][5].

Research and Development

Ongoing R&D efforts to enhance the drug's formulation, improve patient compliance, and explore new therapeutic indications are expanding the market potential for prochlorperazine maleate[2][5].

Market Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Safety Issues and Side Effects

Safety concerns and negative side effects associated with prochlorperazine maleate are expected to hamper market growth. These side effects can include serious health issues, which may deter some patients from using the drug[3].

Supply Chain Disruptions

Historical disruptions in the pharmaceutical supply chain, such as those experienced during the pandemic, can impact the availability of prochlorperazine maleate and affect market dynamics[2].

Anti-Competitive Practices

There have been instances of anti-competitive agreements in the market, such as the Market Exclusion Agreement between Alliance and Lexon, which led to significant price increases and cost burdens on healthcare systems[4].

Competitive Landscape

The Prochlorperazine Maleate Market is highly competitive, with several major players:

• GlaxoSmithKline plc
• Teva Pharmaceutical Industries Ltd.
• Pfizer Inc.
• Novartis AG
• AstraZeneca plc
• Mylan N.V.
• Sanofi S.A.
• Johnson & Johnson
• AbbVie Inc.
• Eli Lilly and Company
• Merck & Co., Inc.
• Bristol-Myers Squibb Company
• Boehringer Ingelheim International GmbH
• Sun Pharmaceutical Industries Ltd.
• Lupin Limited[2]

These companies are profiled based on their product offerings, market entry year, and other market-related factors, providing a comprehensive overview of the competitive landscape[1][2].

Financial Impact and Projections

The financial trajectory of the Prochlorperazine Maleate Market is characterized by steady growth. Here are some key financial projections:

• Market Size in 2023: USD 1.46 billion
• Projected Market Size by 2030: USD 1.85 billion
• CAGR from 2023 to 2030: 3.4%[3][5].

Regional Revenue Share

North America is expected to maintain its significant revenue share due to its advanced healthcare infrastructure and high prevalence of conditions requiring antiemetic therapy. Europe also remains a crucial market, driven by similar factors[2][5].

Analysts’ Views

Industry analysts emphasize the importance of prochlorperazine maleate in managing severe nausea and vomiting, as well as its role in treating mental health disorders. The rising awareness about mental health and the availability of effective treatments are key factors driving market growth[5].

"Prochlorperazine maleate is an antiemetic and antipsychotic medication, primarily used to control severe nausea and vomiting, as well as to treat symptoms of schizophrenia. It works by blocking or lessening the effects of dopamine, a chemical in the brain that can become imbalanced in certain conditions."[5]

Key Takeaways

• The Prochlorperazine Maleate Market is projected to grow from USD 1.46 billion in 2023 to USD 1.85 billion by 2030 at a CAGR of 3.4%.
• The market is driven by the drug's efficacy in managing nausea and vomiting, particularly in chemotherapy and postoperative procedures.
• North America and Europe are significant regions contributing to the market's revenue.
• Safety issues and supply chain disruptions are potential restraints to market growth.
• Ongoing R&D and growing patient awareness are key drivers of the market.

FAQs

Q: What is the current market size of the Prochlorperazine Maleate Market? A: The current market size of the Prochlorperazine Maleate Market is valued at approximately USD 1.46 billion as of 2023[3][5].

Q: What is the projected growth rate of the Prochlorperazine Maleate Market from 2023 to 2030? A: The Prochlorperazine Maleate Market is expected to grow at a compound annual growth rate (CAGR) of 3.4% from 2023 to 2030[3][5].

Q: Which regions hold significant revenue shares in the Prochlorperazine Maleate Market? A: North America and Europe hold significant revenue shares in the global Prochlorperazine Maleate Market[2][5].

Q: What are the primary indications for the use of prochlorperazine maleate? A: The primary indications include severe nausea and vomiting, vertigo, and mental health disorders such as schizophrenia[2][3][5].

Q: What are some of the major challenges facing the Prochlorperazine Maleate Market? A: Safety issues, negative side effects, and historical supply chain disruptions are some of the major challenges facing the market[2][3][4].

Sources Cited:

1. Market Research Intellect - Prochlorperazine Maleate Market Size, Scope And Forecast Report[1]
2. InsightAce Analytic - Prochlorperazine Maleate Market Share, Size, Growth and Forecast[2]
3. Coherent Market Insights - Prochlorperazine Maleate Market, By Indication, By Dosage Form[3]
4. CATribunal - Prochlorperazine (1432;1434;1438-1439) - Judgment[4]
5. Coherent Market Insights - Prochlorperazine Maleate Market Size and Forecast to 2030[5]