HALOPERIDOL Drug Patent Profile

Which patents cover Haloperidol, and when can generic versions of Haloperidol launch?

Haloperidol is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, SCS, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, 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, Strides Pharma, Upsher Smith Labs, Zydus Pharms Usa, Hospira, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic. and is included in one hundred and seven NDAs.

The generic ingredient in HALOPERIDOL is haloperidol decanoate. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Haloperidol

A generic version of HALOPERIDOL was approved as haloperidol decanoate by FRESENIUS KABI USA on December 19^th, 1997.

Summary for HALOPERIDOL

US Patents:	0
Applicants:	45
NDAs:	107
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	219
Patent Applications:	3,866
Drug Prices:	Drug price information 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
Lederle	HALOPERIDOL	haloperidol	TABLET;ORAL	072732-001	Sep 19, 1989		DISCN	No	No
Quantum Pharmics	HALOPERIDOL	haloperidol	TABLET;ORAL	071257-001	Feb 17, 1987		DISCN	No	No
Aiping Pharm Inc	HALOPERIDOL	haloperidol	TABLET;ORAL	071130-003	May 12, 1987	AB	RX	No	No
Actavis Group	HALOPERIDOL	haloperidol	TABLET;ORAL	200854-002	Jul 1, 2022		DISCN	No	No
Sandoz	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	076463-002	Jun 24, 2005		DISCN	No	No
Mylan	HALOPERIDOL	haloperidol	TABLET;ORAL	070278-004	Jun 10, 1986	AB	RX	No	No
Strides Pharma	HALOPERIDOL	haloperidol	TABLET;ORAL	071235-002	Nov 3, 1986		DISCN	No	No

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].