Chlorpromazine hydrochloride - Generic Drug Details

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

Chlorpromazine hydrochloride is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Actavis Mid Atlantic, Genus, Pharm Assoc, Wockhardt, Hikma, Fosun Pharma, Abraxis Pharm, Deva Hlding, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Marsam Pharms Llc, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Chartwell Rx, Abbott, Alembic, Amneal Pharms Co, Appco, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, MSN, Purepac Pharm, Pvt Form, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, Zydus Lifesciences, and Parke Davis, and is included in seventy-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for chlorpromazine hydrochloride. Twenty-nine suppliers are listed for this compound.

Summary for chlorpromazine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	39
NDAs:	79
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	37
Patent Applications:	3,637
What excipients (inactive ingredients) are in chlorpromazine hydrochloride?	chlorpromazine hydrochloride excipients list
DailyMed Link:	chlorpromazine hydrochloride at DailyMed

Recent Clinical Trials for chlorpromazine hydrochloride

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

Sponsor	Phase
Cancer Prevention Research Institute of Texas	Phase 2/Phase 3
Sadat City University	Phase 1/Phase 2
Varun Monga, MD	Phase 1

See all chlorpromazine hydrochloride clinical trials

Pharmacology for chlorpromazine hydrochloride

Drug Class

Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for chlorpromazine hydrochloride

N05AA	Phenothiazines with aliphatic side-chain
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

N05AA	Phenothiazines with aliphatic side-chain
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for chlorpromazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	084415-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lupin	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	213327-003	Jul 13, 2023	AB	RX	No	No
Alembic	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	217350-005	Jul 18, 2023	AB	RX	No	No
Parke Davis	PROMAPAR	chlorpromazine hydrochloride	TABLET;ORAL	084423-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wockhardt	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	CONCENTRATE;ORAL	087053-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Amneal Pharms Co	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	209755-002	Sep 10, 2018	AB	RX	No	No

Chlorpromazine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorpromazine Hydrochloride

Introduction to Chlorpromazine Hydrochloride

Chlorpromazine hydrochloride, commonly known as chlorpromazine HCL, is a first-generation antipsychotic drug used to treat various mental health disorders, including schizophrenia, bipolar disorder, and severe agitation. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global chlorpromazine HCL market is expected to experience significant growth over the forecast period. According to market research, the market size is anticipated to expand at a remarkable CAGR from 2024 to 2031, driven by increasing demand for mental health treatments and the affordability of generic versions of the drug[1][4].

Segmentation of the Market

The chlorpromazine HCL market is segmented based on several factors:

Type

• The market is categorized into purity levels, such as purity ≥ 98% and purity ≥ 99%. These segments are crucial as they affect the drug's efficacy and safety[1].

Application

• Chlorpromazine HCL is used in various forms, including tablets and injection solutions. Each form has its own market dynamics and user base[1].

Geography

• The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is particularly significant, with a projected increase in market size due to the rising incidence of mental health issues[1][4].

Drivers of Market Growth

Several factors are driving the growth of the chlorpromazine HCL market:

Increasing Prevalence of Mental Health Disorders

• The global burden of mental health problems is rising, creating a higher demand for efficient pharmaceutical therapies like chlorpromazine HCL. This trend is particularly pronounced in regions with aging populations and increasing awareness about mental health[3][4].

Affordability of Generic Versions

• Generic versions of chlorpromazine HCL are equally safe and effective as their branded counterparts but are significantly cheaper. This makes them a preferred choice for patients, insurers, and healthcare professionals, especially in healthcare systems with tightening budgets[4].

Government Policies and Reimbursement

• In the U.S., policies such as the Mental Health Parity Act of 1996 and the Americans with Disabilities Act support the equal treatment of mental health conditions in insurance plans, which boosts the market for antipsychotic drugs, including chlorpromazine HCL[3].

Challenges and Restraints

Despite the growth drivers, there are several challenges and restraints affecting the market:

Safety Concerns

• Chlorpromazine HCL, like other antipsychotic drugs, has safety concerns, particularly in elderly patients with dementia-related psychosis. These concerns can limit its use in certain patient populations[2].

Competition from Newer Generations of Antipsychotics

• The market is also influenced by the presence of second and third-generation antipsychotic drugs, which have stronger safety profiles and greater efficacy. This competition can impact the market share of first-generation drugs like chlorpromazine HCL[3].

Competitive Landscape

The chlorpromazine HCL market features a mix of established and emerging players:

Key Companies

• Companies such as Watanabe Chemical, Rasino Drugs, Global Pharma, RL Fine Chem, EUROAPI, and others are prominent in the market. These companies are profiled based on their product offerings, market entry year, and other market-related factors[1].

Market Structure

• The market reflects a semi-consolidated structure, with significant players focusing on R&D initiatives and strategic activities to maintain their market position[3].

Financial Trajectory

The financial trajectory of the chlorpromazine HCL market is promising:

Revenue Projections

• The market is expected to generate substantial revenue during the forecast period, with projections indicating a continued and significant expansion from 2024 to 2031[1].

CAGR and Growth Rate

• The market is anticipated to grow at a CAGR of around 6-7% during the forecast period, driven by the factors mentioned above[1][4].

Distribution Channels

The distribution of chlorpromazine HCL is critical for its market performance:

Hospital Pharmacies

• Hospital pharmacies hold the largest market share due to the comprehensive examinations and prescriptions by trained medical professionals. Suitable reimbursement policies also support this segment[3].

Drug Stores and Retail Pharmacies

• These channels are significant as they allow for the purchase of oral prescription drugs and prescription refills, making them a key distribution channel[3].

Online Pharmacies

• Online pharmacies are expected to grow at the highest CAGR due to their convenience and ease of access for patients[3].

Regulatory and Safety Considerations

Chlorpromazine HCL is subject to various regulatory and safety considerations:

Dosage and Administration

• The drug has specific dosage guidelines, especially for different age groups and conditions. It is crucial to follow these guidelines to minimize adverse effects[2].

Safety Alerts

• Chlorpromazine HCL is not approved for the treatment of dementia-related psychosis in elderly patients due to increased mortality risks. This restriction impacts its use in certain patient populations[2].

Key Takeaways

• The chlorpromazine HCL market is expected to grow significantly due to increasing demand for mental health treatments and the affordability of generic versions.
• The market is segmented by type, application, and geography, with the Asia-Pacific region showing promising growth.
• Drivers include the rising prevalence of mental health disorders and supportive government policies.
• Challenges include safety concerns and competition from newer generations of antipsychotics.
• The market features a semi-consolidated structure with significant players focusing on R&D and strategic activities.

FAQs

1. What are the primary uses of chlorpromazine hydrochloride? Chlorpromazine hydrochloride is primarily used to treat mental disorders such as schizophrenia, bipolar disorder, and severe agitation.

2. What are the key drivers of the chlorpromazine HCL market? The key drivers include the increasing prevalence of mental health disorders, the affordability of generic versions, and supportive government policies.

3. Which region is expected to show significant growth in the chlorpromazine HCL market? The Asia-Pacific region is anticipated to show significant growth due to the rising incidence of mental health issues.

4. What are the safety concerns associated with chlorpromazine HCL? Chlorpromazine HCL has safety concerns, particularly in elderly patients with dementia-related psychosis, and is not approved for this use.

5. How is the competitive landscape of the chlorpromazine HCL market? The market reflects a semi-consolidated structure with significant players focusing on R&D initiatives and strategic activities to maintain their market position.

Cited Sources

1. Market Research Intellect: Global Chlorpromazine HCL Market Size, Trends and Projections[1].
2. UpToDate Free: Chlorpromazine: Pediatric drug information[2].
3. Fortune Business Insights: U.S. Antipsychotic Drugs Market Size, Share | Growth [2030][3].
4. Valuates Reports: Global Chlorpromazine HCL Market Research Report 2023[4].