Haloperidol - Generic Drug Details

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

Haloperidol is the generic ingredient in six branded drugs marketed by Ortho Mcneil, Ortho Mcneil Pharm, Actavis Group, Aiping Pharm Inc, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, SCS, Strides Pharma, Watson Labs, Zydus Pharms Usa, Janssen Pharms, Caplin, Fresenius Kabi Usa, Gland, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, Zydus Pharms, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon Research, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Gland Pharma Ltd, Marsam Pharms Llc, Sagent Pharms, Smith And Nephew, Solopak, and Actavis Mid Atlantic, and is included in one hundred and thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for haloperidol. Twenty-one suppliers are listed for this compound.

Summary for haloperidol

US Patents:	0
Tradenames:	6
Applicants:	50
NDAs:	113
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	219
Patent Applications:	6,792
Drug Prices:	Drug price trends for haloperidol
What excipients (inactive ingredients) are in haloperidol?	haloperidol excipients list
DailyMed Link:	haloperidol at DailyMed

See drug prices for haloperidol

See drug sales revenues for haloperidol

Recent Clinical Trials for haloperidol

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

Sponsor	Phase
Assiut University	Phase 4
Christian Hassager	Phase 3
Qilu Pharmaceutical Co., Ltd.	Phase 3

See all haloperidol clinical trials

Pharmacology for haloperidol

Drug Class

Typical Antipsychotic

Medical Subject Heading (MeSH) Categories for haloperidol

Anti-Dyskinesia Agents

Antiemetics

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for haloperidol

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for haloperidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purepac Pharm	HALOPERIDOL	haloperidol	TABLET;ORAL	071076-001	Aug 4, 1987		DISCN	No	No
Epic Pharma Llc	HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	204849-001	Sep 6, 2017		DISCN	No	No
Mylan	HALOPERIDOL	haloperidol	TABLET;ORAL	070278-003	Jul 16, 2009	AB	RX	No	No
Appco	HALOPERIDOL	haloperidol	TABLET;ORAL	211061-006	Jan 8, 2020	AB	RX	No	No
Appco	HALOPERIDOL	haloperidol	TABLET;ORAL	211061-003	Jan 8, 2020	AB	RX	No	No
Pharm Assoc	HALOPERIDOL	haloperidol lactate	CONCENTRATE;ORAL	073037-001	Feb 26, 1993	AA	RX	No	Yes

Expired US Patents for haloperidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-001	Approved Prior to Jan 1, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-005	Approved Prior to Jan 1, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-006	Feb 2, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-002	Approved Prior to Jan 1, 1982	3,438,991

Market Dynamics and Financial Trajectory for Haloperidol

Last updated: July 27, 2025

Introduction

Haloperidol is a high-potency typical antipsychotic medication primarily indicated for schizophrenia, acute psychosis, and tourette’s syndrome. Since its approval in the 1960s, haloperidol has become a cornerstone in psychiatric pharmacology. Despite the advent of atypical antipsychotics, the drug maintains relevance due to its efficacy, cost-effectiveness, and widespread use. This analysis explores current market dynamics, emerging trends, competitive landscape, and financial projections informing haloperidol's future trajectory.

Historical Context and Regulatory Status

Initially approved in the United States in 1967 by Janssen Pharmaceutica, haloperidol established itself rapidly as a treatment of choice for psychotic disorders[1]. Its patent expired in the late 20th century, leading to generic availability, which significantly influenced its market positioning. Regulatory agencies globally continue to recognize haloperidol’s efficacy, but ongoing concerns about adverse effects, particularly extrapyramidal symptoms, have prompted shifts toward newer agents.

Market Dynamics

Global Demand and Epidemiological Trends

The global burden of mental health disorders has fueled sustained demand for antipsychotics. Approximately 1 in 100 people worldwide suffer from schizophrenia, with a lifetime prevalence of about 0.3-0.7%[2]. Even as newer drugs emerge, haloperidol’s affordability and familiarity keep its consumption steady in many regions, especially in low- and middle-income countries (LMICs).

In high-income markets, demand has plateaued, driven by prescriber preference for atypical antipsychotics like risperidone and olanzapine due to their improved side-effect profiles. Nonetheless, in resource-constrained settings, haloperidol remains the primary antipsychotic due to cost considerations and regulatory approvals.

Therapeutic Positioning and Prescriber Trends

While atypical antipsychotics dominate new prescriptions due to reduced extrapyramidal symptoms, haloperidol retains clinical utility, especially in emergency settings, such as acute psychotic episodes and agitation control. Its versatility is evidenced by off-label uses including delirium management in ICUs and as part of parenteral formulations.

Prescriber preference is influenced by clinical guidelines, patient tolerance, and side-effect management. The longstanding clinical experience with haloperidol sustains its market share, especially where clinicians prioritize cost-effectiveness.

Competitive Landscape

The pharmaceutical market for antipsychotics has become increasingly competitive. Key competitors include atypical agents like risperidone, quetiapine, aripiprazole, and newer compounds like lurasidone. These drugs offer better side-effect profiles but are often priced higher.

Generic manufacturers dominate the nascent segments of haloperidol's market. Industry players have also explored formulations such as long-acting injectables, although these are more prominent in atypical antipsychotics.

Pricing and Reimbursement Dynamics

Post-patent expiration, haloperidol’s pricing plummeted, making it highly competitive in price-sensitive settings. Reimbursement policies and formulary inclusions significantly influence market penetration.

In developed markets, insurance and government programs favor newer, branded products, which contribute to slower growth or decline for haloperidol. Conversely, in LMICs, cost considerations sustain its demand, with procurement often through government tenders or NGOs.

Emerging Trends Impacting Financial Trajectory

Shift Toward Atypical Antipsychotics

Clinicians prefer atypicals due to better patient adherence, lower extrapyramidal symptoms, and favorable side-effect profiles. As a result, some regions report declining haloperidol prescriptions. However, the cost differential sustains its use where affordability is critical.

Off-Label Uses and New Formulations

Off-label sinusoidal applications—such as use in delirium and agitation—maintain demand. Development of novel formulations, including depot injections, could extend haloperidol’s relevance, especially in custodial or institutional settings.

Regulatory and Safety Concerns

Increased awareness of adverse effects, especially tardive dyskinesia and cardiac risks like QT prolongation, has prompted stricter regulatory scrutiny. This, combined with a resurgence in mental health awareness, influences prescribing behaviors and market stability.

Market Entry of Biosimilars and Generics

The proliferation of generic haloperidol biosimilars has drastically reduced prices, consolidating its position as a cost-effective option. This trend is expected to persist, supporting stable or growing demand in resource-limited markets.

Impact of Global Mental Health Initiatives

International efforts to improve mental health access emphasize essential medicines like haloperidol. This aligns with WHO’s Essential Medicines List, bolstering its sustained demand, especially in underserved regions.

Financial Trajectory and Market Forecast

Revenue Trends

In 2022, the global antipsychotics market surpassed USD 15 billion, with haloperidol comprising a significant segment, primarily in LMICs[3]. Despite a slow decline in high-income regions, the overall demand remains stable, driven by the essential nature of the drug.

Growth Projections

Analysts project a compound annual growth rate (CAGR) of approximately 2-3% for the global haloperidol market over the next five years, primarily fueled by emerging markets' expanding mental health infrastructure and ongoing generic sales.

Geographical Breakdown

• North America & Western Europe: Marginal growth or decline owing to the preference for atypicals.
• Asia-Pacific & Latin America: Steady growth driven by increasing mental health awareness and affordability constraints favoring generics.
• Africa & Middle East: High demand due to reliance on low-cost formulations and expanding healthcare access.

Risks and Opportunities

• Risks: Intensified regulatory scrutiny, safety concerns, declining prescriber preference for haloperidol, and competition from newer agents.
• Opportunities: Development of improved formulations, off-label adoption in new clinical settings, and inclusion in global formulary lists.

Conclusion

Haloperidol's market dynamics are characterized by a transition phase, influenced by safety concerns, evolving treatment paradigms, and economic factors. Its financial trajectory remains stable in cost-sensitive markets while facing headwinds in developed regions favoring newer drugs. The continued relevance of haloperidol hinges on patient affordability, regulatory stances, and innovations in drug delivery.

Key Takeaways

• Sustained demand in LMICs: Cost-effectiveness ensures haloperidol remains a vital psychiatric medication in lower-income regions.
• Declining in high-income markets: Prescriber preference for atypical antipsychotics limits growth but maintains baseline sales.
• Generic and biosimilar proliferation: Price competition supports continued affordability and access.
• Emerging formulations: Long-acting injectable options could enhance adherence, extending market relevance.
• Regulatory vigilance: Safety concerns necessitate ongoing monitoring and risk mitigation strategies.

FAQs

1. Will haloperidol remain relevant in the next decade?
Yes. Its affordability, efficacy, and inclusion in essential medicine lists ensure ongoing usage, especially in resource-limited settings. However, growth is expected to plateau in developed markets due to clinical preferences shifting toward atypical antipsychotics.

2. How do safety concerns impact haloperidol’s market?
Safety issues such as extrapyramidal symptoms and cardiac risks have led to cautious prescribing and regulatory review, which in some regions promotes the adoption of newer agents with improved side-effect profiles.

3. Are there ongoing innovations related to haloperidol?
Yes. Development of long-acting injectable formulations aims at improving adherence, especially in institutional care settings, and may bolster its future market.

4. How does the global mental health landscape influence haloperidol sales?
Rising awareness and initiatives to expand mental health access, particularly in LMICs, favor the continued use of low-cost medications like haloperidol, maintaining steady demand.

5. What is the impact of biosimilars on haloperidol’s market?
Biosimilar production significantly reduces costs, increasing affordability and accessibility, thus supporting its market stability and extending its reach in developing regions.

---

Sources:

1. [1] North American Pharmacology Review, 2022.
2. [2] World Health Organization, 2021. Mental health atlas.
3. [3] MarketWatch, 2023. Global Antipsychotics Market Report.