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-two 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:	139
Clinical Trials:	46
Patent Applications:	3,119
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 Institutes of Health (NIH)	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	TABLET;ORAL	015921-002	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
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	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
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-002	Jan 31, 1997	AO	RX	Yes	Yes

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	015921-004	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	015921-002	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

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)

Market Overview

HALDOL, or haloperidol, is a widely used antipsychotic medication, particularly for treating mental diseases such as schizophrenia and other psychotic disorders. The market for haloperidol is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global haloperidol market is anticipated to exhibit substantial growth during the forecast period from 2024 to 2031. This growth is expected to be driven by an increasing demand for antipsychotic medications, particularly in regions with growing populations and rising healthcare expenditures. The market is projected to grow at a remarkable CAGR, indicating a strong potential for revenue expansion[1][4].

Segmentation

The haloperidol market is segmented based on several criteria:

By Type

• Oral: This segment accounts for a significant portion of the market due to the ease of administration and patient compliance.
• Injection: Used for acute cases or when oral administration is not feasible, this segment also holds considerable market share[1][4].

By Application

• Mental Disease: The primary application of haloperidol, treating conditions such as schizophrenia, bipolar disorder, and other psychotic disorders.
• Others: Includes other medical conditions where haloperidol may be prescribed, such as severe behavioral problems in children and Tourette's syndrome[1][4].

By Geography

• North America: A major market due to advanced healthcare infrastructure and high healthcare spending.
• Europe: Another significant market with a large patient base and robust healthcare systems.
• Asia-Pacific: Expected to grow rapidly due to increasing healthcare needs and economic growth.
• South America and Middle-East & Africa: Also showing potential for growth, though at a slower pace compared to other regions[1][4].

Drivers of Market Growth

Several factors are driving the growth of the haloperidol market:

Increasing Prevalence of Mental Health Disorders

The rising incidence of mental health disorders globally is a primary driver. As populations grow and awareness about mental health increases, the demand for effective treatments like haloperidol is expected to rise[1][4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, are making it easier for patients to access antipsychotic medications. This expansion of healthcare services is a significant growth driver[1].

Economic Factors

The growing economic stability in many regions allows for increased healthcare spending, which in turn boosts the demand for pharmaceuticals like haloperidol[1][4].

Restraints and Challenges

Despite the growth potential, the haloperidol market faces several challenges:

Side Effects and Safety Concerns

Haloperidol is associated with various side effects, including extrapyramidal symptoms (EPS), tardive dyskinesia, and neuroleptic malignant syndrome. These adverse effects can limit its use and impact market growth[5].

Cost and Economic Burden

Haloperidol, particularly when compared to atypical antipsychotics, can be more expensive in terms of total treatment costs, including hospitalization expenses. This economic burden can be a restraint, especially in regions with limited healthcare resources[3].

Competitive Landscape

The haloperidol market is competitive, with several key players:

Major Players

• Sandoz
• Mylan
• Teva
• Fresenius Kabi
• Gland Pharma
• Zydus

These companies are profiled based on their product portfolios, financial statements, strategic market approaches, and geographical reach. The competitive landscape also includes recent developments, partnerships, mergers and acquisitions, and product launches[1].

Financial Trajectory

The financial outlook for the haloperidol market is promising:

Revenue Projections

The market is expected to generate significant revenue during the forecast period, with projections indicating exponential growth. The revenue is measured in USD million and is forecasted to increase substantially from 2024 to 2031[1][4].

CAGR

The Compound Annual Growth Rate (CAGR) for the haloperidol market is anticipated to be remarkable, reflecting strong growth rates. This growth is driven by increasing demand, advancements in healthcare, and economic factors[1][4].

Market Opportunities

The market presents several opportunities, including expanding into new patient populations and leveraging advancements in healthcare infrastructure. Companies are also focusing on innovative strategies, such as partnerships and product expansions, to capitalize on market growth[1][4].

Market Outlook

The market outlook is positive, with several factors contributing to its growth:

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals that the market is influenced by factors such as competitive rivalry, threat of new entrants, bargaining power of suppliers and buyers, and the threat of substitute products. Understanding these forces helps in shaping marketing initiatives and strategic decisions[1].

Macro-Economic Scrutiny

The market is also influenced by macro-economic factors such as economic stability, healthcare policies, and demographic changes. These factors play a crucial role in determining the market's evolutionary path and growth potential[1].

Value Chain Evaluation

A detailed evaluation of the value chain, from production to distribution, highlights areas of efficiency and potential for cost reduction. This analysis is critical for maintaining competitiveness in the market[1].

Key Takeaways

• The haloperidol market is expected to grow significantly from 2024 to 2031, driven by increasing demand for antipsychotic medications.
• The market is segmented by type (oral and injection), application (mental disease and others), and geography.
• Key drivers include the rising prevalence of mental health disorders, advancements in healthcare infrastructure, and economic factors.
• Challenges include side effects, safety concerns, and economic burdens.
• The competitive landscape is dominated by several major players, with a focus on strategic market approaches and product expansions.
• The financial trajectory indicates strong revenue growth and a remarkable CAGR.

FAQs

What are the primary segments of the haloperidol market?

The haloperidol market is segmented by type (oral and injection), application (mental disease and others), and geography (North America, Europe, Asia-Pacific, South America, and Middle-East & Africa)[1][4].

Which region is expected to dominate the haloperidol market?

North America and Europe are currently significant markets, but the Asia-Pacific region is expected to grow rapidly due to increasing healthcare needs and economic growth[1][4].

What are the major side effects associated with haloperidol?

Haloperidol is associated with side effects such as extrapyramidal symptoms (EPS), tardive dyskinesia, neuroleptic malignant syndrome, and other CNS effects[5].

How does the cost of haloperidol compare to other antipsychotics?

Haloperidol can be more expensive in terms of total treatment costs, including hospitalization expenses, compared to some atypical antipsychotics[3].

What is the expected CAGR for the haloperidol market?

The haloperidol market is anticipated to grow at a remarkable CAGR during the forecast period from 2024 to 2031[1][4].

Sources

1. MarketResearchIntellect: Global Haloperidol Market Size, Trends and Projections.
2. Johnson & Johnson: Innovative Medicine Presentation.
3. PubMed: A pharmacoeconomic analysis of atypical antipsychotics.
4. Cognitive Market Research: Global Haloperidol Competitive Market Report 2024 Edition.
5. FDA: Haldol (haloperidol) Label.