CHLORPROMAZINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug 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, Rubicon, Wockhardt, Hikma, Saptalis Pharms, Abraxis Pharm, Aspiro, Deva Hlding, Dr Reddys, Eugia Pharma, Gland, Marsam Pharms Llc, Thinq Pharm-cro Pvt, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Chartwell Rx, Abbott, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, 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 eighty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CHLORPROMAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	43
NDAs:	83
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Patent Applications:	4,029
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
University Hospital, Strasbourg, France	PHASE2
Capital Medical University	PHASE1
Linyi People's Hospital	PHASE1

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
Watson Labs	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	085956-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Amneal Pharms Co	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	209755-005	Sep 10, 2018	AB	RX	No	No
Lannett Co Inc	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	212996-005	Jan 22, 2021	AB	RX	No	No

Market Dynamics and Financial Trajectory for Chlorpromazine Hydrochloride

Last updated: July 27, 2025

Introduction

Chlorpromazine Hydrochloride (CPZ), a pioneering antipsychotic agent introduced in the 1950s, revolutionized psychiatric treatment. As the first widely used drug in the phenothiazine class, it marked the beginning of modern psychopharmacology. Despite its age, chlorpromazine remains relevant within the pharmaceutical landscape, particularly in specific medical applications. Analyzing its market dynamics and financial trajectory involves examining historical trends, current market positioning, regulatory factors, and future opportunities.

Historical Market Landscape

Since its FDA approval in 1954, chlorpromazine has been pivotal in managing schizophrenia, psychosis, and nausea. The broad acceptance contributed to significant revenue streams for both innovator companies and generic manufacturers. Its robust patent protection expired decades ago, enabling multiple generic competitors, which significantly influenced pricing and market penetration.

While newer atypical antipsychotics like risperidone and olanzapine have gained market share due to improved side effect profiles, chlorpromazine retained niche applications, particularly within developing regions and in specific psychiatric practices. Its low-cost profile and longstanding clinical familiarity sustain steady, albeit declining, demand.

Current Market Dynamics

Global Market Size

The global psychotropic drugs market, valued at over $40 billion in 2022, includes chlorpromazine among older antipsychotic medicines. Though precise market share data for chlorpromazine is scarce, estimates suggest it accounts for less than 5% of the overall antipsychotic segment, predominantly within low-income and rural regions where affordability outweighs newer drug advantages.

Key Market Drivers

• Cost-Effectiveness: Chlorpromazine’s low manufacturing costs make it a preferred choice in economically constrained healthcare settings. This affordability sustains demand amid rising healthcare expenditures elsewhere.

• Niche Therapeutic Uses: Beyond schizophrenia, chlorpromazine is employed in severe nausea, vomiting, and for controlling agitation in specific settings, maintaining its clinical relevance.

• Developing Country Adoption: Markets in Africa, Asia, and Latin America rely heavily on older, generic medications like chlorpromazine due to access and affordability issues.

Market Challenges

• Side Effect Profile: Significant adverse effects such as sedation, anticholinergic effects, and extrapyramidal symptoms limit its use, especially when newer agents have better tolerability.

• Regulatory and Safety Concerns: Evolving safety standards and regulatory scrutiny can impede widespread adoption in developed markets.

• Patent and Generic Competition: Low barriers to generic manufacturing have flooded the market, leading to price erosion and shrinking profit margins for producers.

• Availability of Alternatives: The rise of atypical antipsychotics with improved safety profiles has reduced chlorpromazine integration into newer treatment protocols.

Market Trends and Future Outlook

Shift Towards Atypical Antipsychotics

Despite its longstanding history, chlorpromazine faces fierce competition from second-generation antipsychotics like clozapine, quetiapine, and aripiprazole. These drugs offer better safety profiles and therapeutic advantages, often leading to off-label use reduction of older drugs such as chlorpromazine.

Therapeutic Repositioning

In some markets, chlorpromazine maintains importance in specific indications—such as refractory schizophrenia cases or as an antiemetic in chemotherapy-induced nausea—highlighting its niche resilience.

Regulatory Environment and Patent Status

Since genericization, chlorpromazine’s patent protection no longer exists, limiting exclusive market control. Future growth hinges on regulatory acceptance for new formulations or combination therapies, and on maintaining supply chain robustness.

Emerging Opportunities

• Generic Market Expansion: Focused growth through emerging markets, where affordability remains paramount.
• Formulation Innovation: Development of long-acting injectables or combination therapies could rejuvenate market presence.
• Off-Label and Adjunct Uses: Expanding understanding of its off-label applications can create incremental opportunities.

Financial Trajectory

The revenue for chlorpromazine is projected to decline gradually with the advent of newer therapies, but demand will persist in resource-limited settings. The global generic psyche for psychotropic medications is expected to sustain algebraic revenues in the low hundreds of millions annually, primarily driven by volume rather than price.

In developed markets, the commercial relevance of chlorpromazine is diminishing, symbolizing an industry shift towards newer, more tolerable agents, and a focus on precision medicine. Companies maintaining chlorpromazine portfolios should strategize around niche markets, cost-sensitive regions, and formulation enhancements to sustain financial viability.

Regulatory and Patent Outlook

With its expired patent, chlorpromazine faces minimal regulatory barriers for manufacturing. Nonetheless, regulatory assessments for new formulations or indications could unlock latent markets or extend the lifecycle of existing products. Monitoring international regulatory trends and safety requirements is critical for commercial planning.

Conclusion

Chlorpromazine hydrochloride’s market dynamics reveal a trajectory shaped by historical significance, evolving clinical preferences, and competitive pressures. While it remains essential in certain settings, its future growth prospects are constrained by safety concerns and competition from newer medications. Nevertheless, strategic positioning within low-income markets and niche indications offers continued commercial relevance.

Key Takeaways

• Market Position: Chlorpromazine remains a low-cost, widely available antipsychotic, dominant in resource-limited settings but declining in developed markets.

• Revenue Trajectory: Expect a gradual decrease in revenue, driven by generics, with residual demand maintained primarily on volume.

• Growth Opportunities: Focus on niche indications, formulation innovations, and expansion into emerging markets to sustain financial performance.

• Competitive Landscape: Advances in drug safety profiles and regulatory scrutiny challenge chlorpromazine’s broader use.

• Strategic Considerations: Companies should evaluate diversification, cost-effective manufacturing, and regulatory pathways to optimize long-term value.

FAQs

1. What are the current primary medical applications of chlorpromazine?
   Mainly used for schizophrenia, severe nausea, vomiting, and agitation control, especially in resource-constrained environments.

2. Why has chlorpromazine’s market share declined over the decades?
   Due to safety concerns, side effect profiles, and the advent of second-generation antipsychotics with improved tolerability.

3. Can chlorpromazine still generate significant revenues for pharmaceutical companies?
   Yes, primarily through generic sales in emerging markets; however, overall market size is shrinking.

4. Are there ongoing efforts to develop new formulations of chlorpromazine?
   Limited, but some companies explore long-acting injectables and combination therapies to extend its lifecycle.

5. What factors could revitalize chlorpromazine’s market presence?
   Regulatory approval for new indications, formulation innovations, and expanding access in low-income regions.

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References

1. MarketResearch.com. "Global Psychotropic Drugs Market Analysis." 2022.
2. U.S. Food and Drug Administration. "Chlorpromazine Hydrochloride Drug Approval History." 1954.
3. IMS Health. "Antipsychotic Market Trends in Emerging Markets." 2021.
4. World Health Organization. "Essential Medicines List," 2019.
5. EMA Reports. "Safety and Regulatory Updates on First-Generation Antipsychotics." 2022.