HALDOL Drug Patent Profile

Which patents cover Haldol, and what generic alternatives are available?

Haldol is a drug marketed by Ortho Mcneil, Janssen Pharms, and Ortho Mcneil Pharm. and is included in five NDAs.

The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Haldol

A generic version of HALDOL was approved as haloperidol by MYLAN on June 10^th, 1986.

Summary for HALDOL

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	46
Patent Applications:	709
Drug Prices:	Drug price information for HALDOL
What excipients (inactive ingredients) are in HALDOL?	HALDOL excipients list
DailyMed Link:	HALDOL at DailyMed

See drug prices for HALDOL

Recent Clinical Trials for HALDOL

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

Sponsor	Phase
Western Michigan University School of Medicine	Phase 4
Zuyderland Medisch Centrum	Phase 4
National Institute of Nursing Research (NINR)	Phase 2/Phase 3

See all HALDOL clinical trials

Pharmacology for HALDOL

Drug Class

Typical Antipsychotic

US Patents and Regulatory Information for HALDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-002	Jan 31, 1997	AO	RX	Yes	Yes
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	HALDOL	haloperidol lactate	INJECTABLE;INJECTION	015923-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-001	Jan 14, 1986	AO	RX	Yes	Yes
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for HALDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-006	Feb 2, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	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	015921-002	Approved Prior to Jan 1, 1982	3,438,991
Janssen Pharms	HALDOL	haloperidol lactate	INJECTABLE;INJECTION	015923-001	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	015921-004	Approved Prior to Jan 1, 1982	3,438,991

International Patents for HALDOL

See the table below for patents covering HALDOL around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	895309

Market Dynamics and Financial Trajectory for HALDOL (Haloperidol)

Last updated: July 27, 2025

Introduction

HALDOL (haloperidol) remains a cornerstone in the treatment of schizophrenia and various psychotic disorders. As a typical antipsychotic agent introduced in the late 1950s, haloperidol's longstanding presence establishes both legacy market dominance and opportunities for contemporary growth amidst evolving healthcare landscapes. This analysis delineates market trends, financial implications, and strategic considerations vital for stakeholders assessing HALDOL’s future trajectory.

Overview of HALDOL and Its Therapeutic Profile

Haloperidol, developed by Janssen Pharmaceuticals in 1958, functions as a dopamine D2 receptor antagonist, exerting potent antipsychotic effects. Its applications extend beyond schizophrenia to include acute psychosis, Tourette's syndrome, and off-label uses like severe agitation management. Despite the advent of atypical antipsychotics, haloperidol retains clinical relevance, particularly in inpatient settings and among resource-constrained healthcare systems due to its cost-effectiveness.

Global Market Landscape

The global antipsychotic market is projected to reach approximately USD 11 billion by 2027, with a compound annual growth rate (CAGR) of around 4.2% from 2020 to 2027 [1]. Within this, traditional antipsychotics like haloperidol constitute a significant segment, especially in regions where newer agents face affordability barriers or regulatory constraints.

Market Drivers

1. Cost-Effectiveness and Healthcare Infrastructure

   Haloperidol’s low manufacturing cost and widespread availability position it favorably in emerging economies such as India, China, and Brazil. Governments and healthcare providers often prefer traditional agents to minimize expenditure, fostering consistent demand.

2. Clinical Robustness and Familiarity

   As an extensively studied drug with decades of clinical data, haloperidol benefits from established prescribing patterns. It remains a first-line treatment in acute psychosis management and is integrated into many psychiatric treatment algorithms globally.

3. Generic Availability and Patent Expiry

   Since haloperidol’s patents lapsed decades ago, multiple generic manufacturers produce bioequivalent formulations, ensuring stable supply and competitive pricing. This saturation curtails retail prices while maintaining volumetric sales.

4. Regulatory Approvals

   Regulatory bodies universally approve haloperidol for various indications, facilitating ongoing clinical use and distribution across diverse healthcare markets.

Market Challenges

1. Adverse Effect Profile and Safety Concerns

   Compared to atypical antipsychotics, haloperidol exhibits a higher affinity for extrapyramidal side effects (EPSE), including tardive dyskinesia. These safety concerns have prompted clinicians to prefer newer agents, especially for long-term treatment, thereby constraining volume growth.

2. Shift Toward Atypical Antipsychotics

   The advent of second-generation antipsychotics (risperidone, olanzapine, quetiapine, and aripiprazole) offers improved safety profiles, patient adherence, and fewer EPSE. These drugs command higher margins despite higher costs, translating into market share erosion for traditional drugs like haloperidol.

3. Regulatory and Prescribing Trends

   Many clinical guidelines favor atypical antipsychotics as first-line treatment, especially for long-term management of schizophrenia. This trend impacts demand dynamics, particularly in Western markets.

4. Emerging Pharmacovigilance Concerns

   Recent safety alerts centered on haloperidol’s cardiac risks, including QT prolongation, influence prescribing behaviors and regulatory scrutiny, potentially limiting future expansion.

Financial Trajectory Analysis

Revenue Streams and Pricing Dynamics

Despite challenges, haloperidol’s revenue remains resilient due to their widespread use and robust generic competition. Market reports indicate that in 2022, global sales of haloperidol formulations exceeded USD 500 million, predominantly driven by developing nations acting as primary markets [2].

Pricing trends exhibit downward pressure owing to generic proliferation. For example, average unit prices for haloperidol injectables in India have decreased by approximately 30% over five years, enabling high-volume sales but constraining profit margins.

Market Share and Volume Trends

In mature markets such as North America and Europe, haloperidol’s market share has declined from approximately 25% in 2010 to below 15% by 2022 [3]. This decline aligns with increased adoption of atypicals and concerns surrounding side effect profiles. Conversely, in Middle East and Asian markets, demand remains stable or increasing, owing to cost considerations and healthcare infrastructure.

R&D and Pipeline Considerations

Pharmaceutical companies are investing minimally in haloperidol-specific innovation given its age and market perception. However, some entities explore formulation improvements, such as long-acting injectable (LAI) derivatives, to extend product lifecycle and address adherence issues—potentially providing incremental revenue streams.

Regulatory and Patent Outlook

The absence of patent protections ensures that manufacturing remains commoditized, with pricing dictated chiefly by competition. Regulatory authorities continue to approve HALDOL for existing indications, although new approvals or label expansions are unlikely.

Market Forecast and Strategic Outlook

Given current trends, the global market for HALDOL will likely exhibit modest declines in developed nations but sustain in emerging economies. The compound annual growth rate for haloperidol specifically may hover around -1% to -2% over the next five years, influenced by increased competition from atypical agents and safety considerations.

Nevertheless, high-volume, low-cost markets promise maintained revenue levels, especially through generics. Pharmaceutical firms focusing on developing longer-acting formulations or combination therapies could realize niche growth opportunities. Meanwhile, regulatory agencies’ focus on safety can influence formulary positioning and prescribing practices, further shaping the revenue landscape.

Key Market Dynamics Summary

Parameter	Observation	Implication
Market Growth	Slight decline in Western markets	Shift to atypicals, safety concerns
Emerging Markets	Steady demand	Cost advantage, infrastructure needs
Pricing	Reduced due to generics	Lower margins but higher volume
Innovation	Limited	Revenue stagnation unless formulations evolve
Regulatory Environment	Heightened safety focus	Potential restrictions or precautionary labels

Key Takeaways

• Market resilience persists in emerging economies driven by cost advantages and high-volume demand.
• Shift in prescribing patterns towards atypical antipsychotics constrains HALDOL’s growth in developed markets.
• Generic competition and price erosion threaten profitability, necessitating optimization of manufacturing and distribution strategies.
• Innovation opportunities in long-acting formulations may extend product relevance, especially to improve adherence and safety profiles.
• Regulatory scrutiny on safety signals mandates proactive pharmacovigilance, influencing future market accessibility.

Conclusion

HALDOL’s market and financial outlook hinges on global healthcare economics, clinical prescribing trends, and safety profiles. While it maintains a significant footprint in cost-sensitive settings, its growth trajectory faces headwinds in developed nations overshadowed by the proliferation of atypical antipsychotics. Strategic positioning—through formulation enhancements and targeting emerging markets—can sustain profitability, but innovation and safety management will remain central to its long-term viability.

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Key Takeaways

1. HALDOL remains vital in emerging markets, bolstered by cost benefits and established clinical utility.
2. The global shift toward atypical antipsychotics constrains HALDOL’s growth in mature markets.
3. Price competition driven by generics sustains high-volume sales but reduces margins.
4. Innovation, especially in long-acting formulations, offers avenues for extending market relevance.
5. Safety concerns require vigilant pharmacovigilance, influencing regulatory and prescribing landscapes.

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FAQs

1. What factors influence the current demand for HALDOL globally?
Demand predominantly hinges on healthcare infrastructure and economic factors. Cost considerations favor haloperidol in emerging markets, while clinical safety and efficacy profiles influence Western prescribing decisions.

2. How does the patent status of HALDOL affect its market competition?
Patent expiration resulted in widespread generic manufacturing, fostering price competition and stabilizing demand through affordability but limiting potential profit margins.

3. What are the main safety concerns associated with HALDOL?
Notably, extrapyramidal side effects (EPSE) and QT prolongation pose risks, prompting regulatory scrutiny and impacting clinician preferences.

4. Are there ongoing innovations to extend HALDOL’s market life?
Limited but ongoing developments include long-acting injectable formulations aimed at improving adherence and reducing side effects.

5. How do regulatory changes impact HALDOL’s market trajectory?
While existing approvals remain intact, heightened safety regulations and labeling requirements may restrict usage or necessitate updated warnings, potentially affecting sales.

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Sources
[1] Grand View Research. "Antipsychotic Drugs Market Size, Share & Trends Analysis Report." 2022.
[2] IQVIA. "Market Data on Global Generic Drug Sales," 2022.
[3] Pharma Intelligence. "Schizophrenia Treatment Market Overview," 2022.