PROCHLORPERAZINE - Generic Drug Details

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

Prochlorperazine is the generic ingredient in six branded drugs marketed by Glaxosmithkline, Padagis Us, Able, Cosette, 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, Wyeth Ayerst, Ajanta Pharma Ltd, 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 fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for prochlorperazine. Three suppliers are listed for this compound.

Summary for PROCHLORPERAZINE

US Patents:	0
Tradenames:	6
Applicants:	36
NDAs:	55
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	50
Patent Applications:	6,587
Drug Prices:	Drug price trends for PROCHLORPERAZINE
Drug Sales Revenues:	Drug sales revenues for PROCHLORPERAZINE
What excipients (inactive ingredients) are in PROCHLORPERAZINE?	PROCHLORPERAZINE excipients list
DailyMed Link:	PROCHLORPERAZINE at DailyMed

See drug prices for PROCHLORPERAZINE

See drug sales revenues for PROCHLORPERAZINE

Recent Clinical Trials for PROCHLORPERAZINE

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

Sponsor	Phase
Washington University School of Medicine	Phase 2
Assertio Holdings, Inc	Phase 2
Dayton Children's Hospital	N/A

See all PROCHLORPERAZINE clinical trials

Pharmacology for PROCHLORPERAZINE

Drug Class

Phenothiazine

Medical Subject Heading (MeSH) Categories for PROCHLORPERAZINE

Antiemetics

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PROCHLORPERAZINE

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

US Patents and Regulatory Information for PROCHLORPERAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avet Lifesciences	PROCHLORPERAZINE EDISYLATE	prochlorperazine edisylate	INJECTABLE;INJECTION	204147-001	Oct 15, 2013	AP	RX	No	Yes
Norvium Bioscience	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	040185-001	Oct 28, 1996		DISCN	No	No
Glenmark Pharms Ltd	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	216595-002	Mar 17, 2023	AB	RX	No	No
Leading	PROCHLORPERAZINE MALEATE	prochlorperazine maleate	TABLET;ORAL	218912-002	Sep 30, 2024	AB	RX	No	No

PROCHLORPERAZINE Market Analysis and Financial Projection Experimental

Prochlorperazine Maleate Market Dynamics and Financial Trajectory

Market Overview

The Prochlorperazine Maleate market is poised for steady and significant growth over the coming years, driven by its established efficacy and widespread use in managing various medical conditions.

Market Size and Growth

• The global Prochlorperazine Maleate market was valued at approximately 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].
• Another forecast suggests that the market could expand from $2.5 billion in 2023 to $4.3 billion by 2033, with a CAGR of approximately 5.8%[5].

Key Drivers of Growth

Established Efficacy

Prochlorperazine maleate is widely recognized for its effectiveness in managing nausea and vomiting, vertigo, and motion sickness. This established efficacy contributes significantly to its demand across various medical specialties, including oncology, gastroenterology, and neurology[1].

Versatility in Treatment

The drug's versatility in treating multiple conditions enhances its market appeal. It is used in different dosage forms such as oral tablets, rectal suppositories, and injectable formulations, catering to a broad range of patient needs[3].

Ongoing Research and Development

Continuous research and development efforts aim to enhance the drug's formulation, improve patient compliance, and explore new therapeutic indications. These initiatives further expand the market potential for prochlorperazine maleate[1].

Market Segmentation

By Indication

• The market is segmented by indication into nausea and vomiting management, vertigo, motion sickness, and other conditions. Nausea and vomiting management remains a significant segment due to the drug's primary use in these areas[3].

By Dosage Form

• Prochlorperazine maleate is available in various dosage forms, including oral tablets, rectal suppositories, and injectable formulations. Each form caters to different patient needs and preferences[3].

By Distribution Channel

• The drug is distributed through hospital pharmacies, retail pharmacies, and online pharmacies. The rise of online pharmacies is expected to contribute to the market's growth by increasing accessibility[3].

By End User

• The end users include hospitals, clinics, ambulatory surgical centers, and homecare settings. The demand from these sectors is driven by the drug's efficacy and the need for effective antiemetic and antipsychotic treatments[3].

Financial Performance of Key Players

ANI Pharmaceuticals

• ANI Pharmaceuticals, a significant player in the market, reported net revenues of $83.8 million in the third quarter of 2022, with a year-over-year net revenue growth of 61%. This growth was partly driven by the launch of new products, including Prochlorperazine Maleate Tablets USP[2].

Other Key Players

• Other major players in the market include Sandoz Inc., Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Glenmark Pharmaceuticals Inc., and Teva Pharmaceutical Industries Ltd. These companies are actively involved in market expansion through new product launches, acquisitions, and strategic partnerships[3].

Recent Developments and Launches

Product Launches

• On August 29, 2022, ANI Pharmaceuticals announced the launch of Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, which is expected to contribute to the market growth[1].

Business Development

• Companies are actively engaging in business development activities such as acquiring new ANDAs (Abbreviated New Drug Applications) and consolidating manufacturing networks. For example, ANI Pharmaceuticals completed the acquisition of four limited-competition ANDAs from Oakrum Pharma LLC in July 2022[2].

Regional Outlook

The Prochlorperazine Maleate market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents unique market dynamics and growth opportunities driven by local healthcare needs and regulatory frameworks[4].

Challenges and Opportunities

Regulatory Frameworks

• The market is influenced by regulatory frameworks across different regions. Compliance with these regulations is crucial for market growth and product approval[3].

Technological Advances

• Recent technological advances and innovations in drug formulation and delivery systems are expected to influence the market positively. These advancements can improve patient compliance and enhance the drug's efficacy[4].

Competitive Landscape

• The competitive landscape is characterized by several key players. The report provides a SWOT analysis of these competitors, helping market participants make informed decisions[3].

Financial Projections and Guidance

• For 2022, ANI Pharmaceuticals reiterated its total company net revenue guidance of $295 million to $315 million, with adjusted non-GAAP EBITDA guidance of $54 million to $60 million and adjusted non-GAAP earnings per share between $1.34 and $1.62[2].

Key Takeaways

• The Prochlorperazine Maleate market is expected to grow steadily due to its established efficacy and versatility in treating multiple conditions.
• Ongoing research and development efforts are crucial for market expansion.
• Key players are actively involved in new product launches, acquisitions, and strategic partnerships.
• The market is segmented by indication, dosage form, distribution channel, and end user, each contributing to its growth.
• Regulatory frameworks and technological advances play significant roles in shaping the market.

FAQs

Q: What is the projected market size of Prochlorperazine Maleate by 2030?

• The global Prochlorperazine Maleate market is projected to reach approximately US$ 1.85 billion by 2030[1].

Q: What is the CAGR of the Prochlorperazine Maleate market from 2023 to 2030?

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

Q: Which companies are key players in the Prochlorperazine Maleate market?

• Key players include Sandoz Inc., Mylan Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Glenmark Pharmaceuticals Inc., and Teva Pharmaceutical Industries Ltd.[3].

Q: What are the primary indications for Prochlorperazine Maleate?

• The primary indications include nausea and vomiting management, vertigo, and motion sickness[3].

Q: How is the Prochlorperazine Maleate market segmented?

• The market is segmented by indication, dosage form, distribution channel, and end user[3].

Sources

1. Coherent Market Insights - Prochlorperazine Maleate Market Size and Trends
2. ANI Pharmaceuticals - Third Quarter 2022 Financial Results
3. OpenPR - Prochlorperazine Maleate Market Overview, Analysis, Growth
4. Market Research Intellect - Global Prochlorperazine Maleate Market Size, Trends and Projections
5. Global Insight Services - Prochlorperazine Maleate Market Size, Growth, Trends and Forecast