CHLORPROMAZINE - Generic Drug Details

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

Chlorpromazine 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, MSN, Thinq Pharm-cro Pvt, Watson Labs, Wyeth Ayerst, Zydus Pharms, Alpharma Us Pharms, Chartwell Rx, Abbott, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Cycle, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Lederle, Lupin, Purepac Pharm, Pvt Form, Somerset Theraps Llc, Sun Pharm, Teva Pharms, Upsher Smith Labs, Vangard, West Ward, Zameer Pharms, Zydus Lifesciences, and Parke Davis, and is included in eighty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-four drug master file entries for chlorpromazine.

Summary for CHLORPROMAZINE

US Patents:	0
Tradenames:	5
Applicants:	44
NDAs:	84
Drug Master File Entries:	24
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	40
Drug Prices:	Drug price trends for CHLORPROMAZINE
What excipients (inactive ingredients) are in CHLORPROMAZINE?	CHLORPROMAZINE excipients list
DailyMed Link:	CHLORPROMAZINE at DailyMed

See drug prices for CHLORPROMAZINE

Recent Clinical Trials for CHLORPROMAZINE

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

Sponsor	Phase
Ji Xunming,MD,PhD	NA
University Hospital, Strasbourg, France	PHASE2
Capital Medical University	PHASE1

See all CHLORPROMAZINE clinical trials

Medical Subject Heading (MeSH) Categories for CHLORPROMAZINE

Antiemetics

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CHLORPROMAZINE

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

US Patents and Regulatory Information for CHLORPROMAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	084803-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	INJECTABLE;INJECTION	080370-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Somerset Theraps Llc	CHLORPROMAZINE HYDROCHLORIDE	chlorpromazine hydrochloride	TABLET;ORAL	213590-001	Aug 31, 2020	AB	RX	No	No

Market Dynamics and Financial Trajectory for Chlorpromazine

Last updated: February 14, 2026

Overview

Chlorpromazine, an antipsychotic medication first marketed in the 1950s, remains a significant drug in the treatment of schizophrenia, psychotic disorders, and to some extent, nausea and vomiting. Despite advancements in psychopharmacology, its market presence persists due to its low cost and efficacy for certain patient populations.

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Market Size and Penetration

The global antipsychotic market was valued at approximately USD 15-17 billion in 2022, with chlorpromazine accounting for a small but stable segment. Its usage has declined relative to atypical antipsychotics (e.g., risperidone, olanzapine), which dominate due to improved side effect profiles.

Market Segmentation

• Psychiatric indications: Schizophrenia, bipolar disorder, psychosis. Chlorpromazine’s use declines with newer drugs but remains in use in developing regions.
• Nausea and vomiting: Prescribed in specific cases but not a primary indication.
• Off-label uses: Rare, but documented.

Regional Market Trends

• North America & Western Europe: Rationales include preference for newer atypical drugs; chlorpromazine's use is limited to specific cases or cost-sensitive settings.
• Emerging Markets: Continued relevance due to lower costs, backed by government procurement policies and lesser regulatory barriers.

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Market Dynamics

Competitive Landscape

• Generic Dominance: Chlorpromazine has been off patent since the 1980s, existing predominantly as generic versions.
• Traditional vs. Newer Therapeutics: The rise of atypical antipsychotics (e.g., aripiprazole, quetiapine) has provided alternatives with fewer extrapyramidal side effects.
• Price Sensitivity: Lower manufacturing costs favor use in developing nations.

Regulatory and Policy Factors

• Regulatory approvals: Remaining approved in multiple jurisdictions; some regions restrict use based on safety.
• Reimbursement policies: Favor generics or newer drugs; chlorpromazine’s reimbursement is limited where newer drugs are preferred.

Supply Chain and Manufacturing

• Manufacturing complexity: Low, due to long-established synthesis processes.
• Supply stability: High, with multiple manufacturers indicating robust supply chains.

Prescriber Trends and Clinical Guidelines

• Clinical guidelines favor atypical antipsychotics, reducing chlorpromazine’s prescription rates.
• Prescriptions mainly in cases where cost or drug tolerability is critical.

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Financial Trajectory and Revenue Outlook

Historical Revenue Data

• Revenue for chlorpromazine has declined steadily since the 1990s, with most sales from generic manufacturers.
• In 2021, U.S. sales were estimated around USD 50-100 million, primarily in low-income regions.

Forecasted Revenue

Year	Estimated Market Share	Predicted Revenue (USD million)	Notes
2023	Stable at 2-3% of antipsychotics	USD 25-50	Declines expected amid competition
2025	Slight decrease to 1-2%	USD 10-30	Competition from newer drugs continues

Key Revenue Drivers

• Cost-related prescriptions in developing countries.
• Use in specific patient populations where newer drugs are contraindicated or unavailable.

Risks

• Regulatory restrictions based on safety profiles.
• Clinical guideline shifts favoring atypicals.
• Market share erosion by branded generics and patent cliffs of newer molecules.

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Regulatory and Patent Landscape

• Patent status: Long expired, no exclusivity periods.
• Regulatory environment: Approvals maintained in most jurisdictions; some regions see restrictions due to safety concerns.
• Reformulation or repositioning potential: Limited; primary use remains in traditional indications.

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Key Takeaways

• Chlorpromazine’s market is shrinking globally but remains vital in cost-sensitive markets.
• The shift toward atypical antipsychotics reduces its overall market share.
• Continued manufacturing presence supports supply stability.
• Revenue projections show a declining trend, with a small but persistent role in the global pharmacopeia.
• Regulatory restrictions and clinical guidelines favor newer options, intensifying market contraction for chlorpromazine.

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FAQs

1. Why has chlorpromazine's market share declined?
The advent of atypical antipsychotics with fewer side effects has shifted prescribing trends away from chlorpromazine.

2. Who are the main competitors to chlorpromazine?
Atypical antipsychotics such as risperidone, olanzapine, and aripiprazole.

3. Can chlorpromazine gain renewed market interest?
Limited potential exists; primarily in low-income markets or specific clinical scenarios where cost outweighs side effects.

4. Are there new formulations or repositioning strategies for chlorpromazine?
No significant development efforts are underway for reformulation or new indications.

5. What regulatory challenges does chlorpromazine face?
Potential restrictions due to safety profiles, especially Parkinsonian side effects, influence regulatory decisions in some jurisdictions.

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References

1. Statista. Global antipsychotic drugs market overview, 2022.
2. IQVIA. Prescription trends for antipsychotics, 2022–2023.
3. US FDA. Drug Approvals and Safety Notices — Chlorpromazine, 2021–2022.
4. MarketWatch. Antipsychotic market forecast, 2023–2025.
5. WHO. Essential medicines list, 2019.