HALOPERIDOL - Generic Drug Details

What are the generic sources for haloperidol and what is the scope of patent protection?

Haloperidol is the generic ingredient in six branded drugs marketed by Ortho Mcneil, Ortho Mcneil Pharm, Actavis Group, Aiping Pharm Inc, 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, Upsher Smith Labs, Watson Labs, Zydus Pharms Usa, Janssen Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, Zydus Pharms, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Marsam Pharms Llc, Sagent Pharms, Smith And Nephew, Solopak, and Actavis Mid Atlantic, and is included in one hundred and twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for HALOPERIDOL

US Patents:	0
Tradenames:	6
Applicants:	48
NDAs:	112
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	219
Patent Applications:	7,053
Drug Prices:	Drug price trends for HALOPERIDOL
Drug Sales Revenues:	Drug sales revenues 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
Gland Pharma Ltd	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	205241-002	May 12, 2017	AO	RX	No	No
Solopak	HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	070864-001	Dec 14, 1987		DISCN	No	No
Aiping Pharm Inc	HALOPERIDOL	haloperidol	TABLET;ORAL	071129-001	Feb 17, 1987		DISCN	No	No
Somerset Theraps Llc	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	209101-002	Jul 3, 2018	AO	RX	No	No
Watson Labs	HALOPERIDOL	haloperidol	TABLET;ORAL	070981-001	Mar 6, 1987		DISCN	No	No
Strides Pharma	HALOPERIDOL	haloperidol	TABLET;ORAL	071235-002	Nov 3, 1986		DISCN	No	No
Purepac Pharm	HALOPERIDOL	haloperidol	TABLET;ORAL	071073-001	Nov 3, 1986		DISCN	No	No

Expired US Patents for HALOPERIDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-005	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	015921-006	Feb 2, 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	015921-003	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

HALOPERIDOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Haloperidol

Introduction to Haloperidol

Haloperidol is a widely used antipsychotic medication, primarily employed in the treatment of schizophrenia and other mental health disorders. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Size and Growth Projections

The haloperidol market is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market size is expected to expand at a remarkable Compound Annual Growth Rate (CAGR) during this period, driven by increasing demand for antipsychotic medications[1][4].

• Forecast Period: The market is projected to grow substantially from 2024 to 2031, with the base year being 2023.
• Market Segments: The market is segmented by type (oral and injection), application (mental disease and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the haloperidol market:

Increasing Mental Health Issues

The rising prevalence of mental health disorders globally is a significant driver. As more people seek treatment for conditions like schizophrenia, the demand for effective antipsychotic medications such as haloperidol increases[3].

Advancements in Healthcare

Improvements in healthcare systems, services, and drug delivery mechanisms are enhancing the effectiveness and accessibility of haloperidol. This includes better diagnostic tools and treatment protocols that encourage the use of antipsychotic medications[3].

Government Initiatives and Awareness

Growing government attention and public awareness about mental health issues are leading to increased investment in mental health care. This heightened awareness encourages early treatment, thereby boosting the demand for haloperidol and other antipsychotic drugs[3].

Market Restraints and Challenges

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

Side Effects and Safety Concerns

Haloperidol is associated with significant side effects, including extrapyramidal symptoms, which can deter some patients and healthcare providers. These safety concerns can limit market growth[2][5].

Cost-Effectiveness and Economic Factors

Haloperidol, while effective, is often more expensive in terms of total treatment costs compared to some atypical antipsychotics. For instance, studies have shown that haloperidol results in higher hospitalization expenses and total treatment costs compared to medications like olanzapine[2][5].

Cost-Effectiveness Analysis

A detailed cost-effectiveness analysis reveals that haloperidol, although effective, may not be the most economical choice:

• Hospitalization Costs: Patients treated with haloperidol tend to have higher hospitalization rates and longer durations of hospital stays, leading to increased total hospitalization expenses[5].
• Treatment Costs: The total treatment cost for haloperidol is higher compared to some atypical antipsychotics, despite the medication acquisition costs of the latter being higher. This is due to the reduced number of hospitalizations associated with atypical antipsychotics[5].

Competitive Landscape

The haloperidol market is competitive, with several key players:

• Major Companies: Sandoz, Mylan, Teva, Fresenius Kabi, Gland Pharma, and Zydus are among the prominent companies in the haloperidol market. These companies are profiled based on their product offerings and market-related factors[1][4].

Geographical Market Dynamics

The market for haloperidol varies significantly across different geographical regions:

• North America and Europe: These regions are expected to contribute substantially to the market growth due to advanced healthcare systems and higher awareness of mental health issues.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a large patient population[1][4].

Financial Trajectory

The financial trajectory of the haloperidol market is characterized by:

• Revenue Growth: The market is expected to generate significant revenue, measured in USD million, across various segments during the forecast period.
• CAGR: The market is projected to grow at a remarkable CAGR, indicating strong growth rates[1][4].

Comparison with Other Antipsychotics

Haloperidol's performance can be compared to other antipsychotic medications:

• Sertindole: Studies have shown that sertindole offers better cost-effectiveness and lower relapse rates compared to haloperidol. Sertindole provides a benefit of 5 months without relapse compared to olanzapine and 13.5 months compared to haloperidol[2].

Conclusion

The haloperidol market is poised for significant growth driven by increasing mental health issues, advancements in healthcare, and government initiatives. However, it faces challenges related to side effects, cost-effectiveness, and competition from other antipsychotic medications.

Key Takeaways

• Market Growth: The haloperidol market is expected to grow substantially from 2024 to 2031.
• Drivers: Increasing mental health issues, healthcare advancements, and government initiatives drive market growth.
• Challenges: Side effects, higher treatment costs, and competition from atypical antipsychotics are significant challenges.
• Geographical Dynamics: North America, Europe, and Asia-Pacific are key regions contributing to market growth.
• Financial Trajectory: The market is projected to generate significant revenue with a remarkable CAGR.

FAQs

1. What is the expected growth rate of the haloperidol market from 2024 to 2031? The haloperidol market is expected to grow at a remarkable CAGR during the forecast period from 2024 to 2031[1][4].

2. What are the primary drivers of the haloperidol market growth? The primary drivers include increasing mental health issues, advancements in healthcare, and government initiatives[3].

3. How does haloperidol compare to other antipsychotic medications in terms of cost-effectiveness? Haloperidol is often more expensive in terms of total treatment costs compared to some atypical antipsychotics, despite its effectiveness[2][5].

4. Which regions are expected to contribute most to the haloperidol market growth? North America, Europe, and Asia-Pacific are anticipated to be the key regions contributing to market growth[1][4].

5. What are the major challenges facing the haloperidol market? The major challenges include side effects, higher treatment costs, and competition from other antipsychotic medications[2][5].

Sources

1. Market Research Intellect: Global Haloperidol Market Size, Trends and Projections[1].
2. Rees-France: Cost-effectiveness of sertindole versus olanzapine or haloperidol[2].
3. Business Research Insights: Pimozide Tablet Market Share | 2024 To 2032[3].
4. Market Research Intellect: Global Haloperidol Competitive Market Size And Forecast[4].
5. PubMed: A pharmacoeconomic analysis of atypical antipsychotics[5].