HALOPERIDOL DECANOATE - Generic Drug Details

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

Haloperidol decanoate is the generic ingredient in two branded drugs marketed by Janssen Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for haloperidol decanoate. Fifteen suppliers are listed for this compound.

Summary for HALOPERIDOL DECANOATE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	8
Patent Applications:	344
Drug Prices:	Drug price trends for HALOPERIDOL DECANOATE
What excipients (inactive ingredients) are in HALOPERIDOL DECANOATE?	HALOPERIDOL DECANOATE excipients list
DailyMed Link:	HALOPERIDOL DECANOATE at DailyMed

See drug prices for HALOPERIDOL DECANOATE

See drug sales revenues for HALOPERIDOL DECANOATE

Recent Clinical Trials for HALOPERIDOL DECANOATE

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 3
National Institute of Mental Health (NIMH)	Phase 3
Case Western Reserve University	Phase 3

See all HALOPERIDOL DECANOATE clinical trials

Pharmacology for HALOPERIDOL DECANOATE

Drug Class

Typical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for HALOPERIDOL DECANOATE

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for HALOPERIDOL DECANOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075440-001	Feb 28, 2000	AO	RX	No	No
Meitheal	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	214507-002	Jul 26, 2021	AO	RX	No	No
Fresenius Kabi Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	074893-002	Dec 19, 1997	AO	RX	No	No
Teva Pharms Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075393-001	May 11, 1999		DISCN	No	No
Meitheal	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	214507-001	Jul 26, 2021	AO	RX	No	No
Sandoz	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	076463-002	Jun 24, 2005		DISCN	No	No
Gland Pharma Ltd	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	205241-001	May 12, 2017	AO	RX	No	No

HALOPERIDOL DECANOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Haloperidol Decanoate

Introduction

Haloperidol decanoate, a long-acting injectable antipsychotic, has been a staple in the treatment of schizophrenia and schizoaffective disorders for decades. This article delves into the market dynamics and financial trajectory of haloperidol decanoate, examining its current status, future projections, and the factors influencing its market performance.

Market Size and Growth Projections

The global haloperidol market, which includes both oral and injectable forms, is expected to experience significant growth. According to market research, the haloperidol market is projected to expand at a remarkable CAGR during the forecast period from 2024 to 2031. The market size is anticipated to grow substantially, driven by increasing demand for antipsychotic medications[3].

Segmentation and Application

The haloperidol market is segmented based on type (oral and injection) and application (mental disease and others). The injectable form, specifically haloperidol decanoate, is a key segment due to its long-acting nature, which is particularly beneficial for patients with schizophrenia who may have adherence issues with daily oral medications. The mental disease segment, which includes schizophrenia and schizoaffective disorders, is the primary application area for haloperidol decanoate[3].

Geographical Distribution

The market for haloperidol decanoate is geographically diverse, with significant presence in North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics, influenced by local healthcare policies, patient demographics, and the availability of alternative treatments[3].

Cost-Effectiveness

A critical aspect of the market dynamics for haloperidol decanoate is its cost-effectiveness compared to other long-acting injectable antipsychotics. A study comparing haloperidol decanoate with paliperidone palmitate found that while paliperidone palmitate offered slightly greater benefits in terms of quality-adjusted life years (QALYs), the significantly higher costs of paliperidone palmitate made haloperidol decanoate more cost-effective. The incremental cost-effectiveness ratio for paliperidone palmitate was $508,241 per QALY, indicating that haloperidol decanoate is a more financially viable option for many healthcare systems[2].

Financial Trajectory

The financial trajectory of haloperidol decanoate is influenced by several factors, including the cost of production, market competition, and regulatory environments. The global haloperidol decanoate API market is expected to reach US$ 720.6 million by 2029, growing at a CAGR of 4.2% from 2023 to 2029. This growth is driven by the increasing demand for long-acting antipsychotics and the expanding patient population[4].

Competitive Landscape

The market for haloperidol decanoate is competitive, with several key players including Sandoz, Mylan, Teva, Fresenius Kabi, Gland Pharma, and Zydus. These companies play a significant role in shaping the market through their production capacities, pricing strategies, and distribution networks. The competitive landscape is further influenced by the presence of generic versions of haloperidol decanoate, which can impact pricing and market share[3].

Regulatory and Legal Considerations

Regulatory and legal factors also impact the market dynamics of haloperidol decanoate. For instance, the approval and reimbursement policies of regulatory bodies can significantly affect the market penetration of the drug. Additionally, legal issues related to the marketing and use of antipsychotic medications, such as those faced by Janssen Pharmaceuticals with risperidone, can influence public and healthcare provider perceptions of similar drugs like haloperidol decanoate[5].

Side Effects and Efficacy

The efficacy and side effect profile of haloperidol decanoate are crucial in determining its market position. A clinical trial comparing haloperidol decanoate with paliperidone palmitate found that while both drugs had similar efficacy rates, haloperidol decanoate was associated with more akathisia (a movement disorder) but less weight gain and lower serum prolactin levels compared to paliperidone palmitate. These findings can influence prescribing decisions and patient adherence[1].

Market Opportunities and Challenges

The market for haloperidol decanoate presents several opportunities and challenges. Opportunities include the growing demand for long-acting antipsychotics, especially in regions with limited access to healthcare services. However, challenges such as competition from newer antipsychotics, regulatory hurdles, and the need for continuous monitoring of side effects must be navigated.

Conclusion

Haloperidol decanoate remains a significant player in the antipsychotic market due to its long-acting nature and cost-effectiveness. The market is expected to grow, driven by increasing demand and the expanding patient population. However, the financial trajectory is influenced by various factors including competition, regulatory environments, and the side effect profile of the drug.

Key Takeaways

• Market Growth: The haloperidol market is projected to grow significantly from 2024 to 2031.
• Cost-Effectiveness: Haloperidol decanoate is more cost-effective compared to paliperidone palmitate.
• Geographical Distribution: The market is diverse, with significant presence in multiple regions.
• Competitive Landscape: Several key players influence the market through production, pricing, and distribution.
• Regulatory Considerations: Approval and reimbursement policies significantly affect market penetration.
• Efficacy and Side Effects: Haloperidol decanoate has a distinct side effect profile compared to other antipsychotics.

FAQs

Q: What is the projected market size for haloperidol decanoate by 2029? A: The global haloperidol decanoate API market is expected to reach US$ 720.6 million by 2029[4].

Q: How does the cost-effectiveness of haloperidol decanoate compare to paliperidone palmitate? A: Haloperidol decanoate is more cost-effective than paliperidone palmitate, with a lower incremental cost-effectiveness ratio[2].

Q: What are the primary applications of haloperidol decanoate? A: The primary application of haloperidol decanoate is in the treatment of schizophrenia and schizoaffective disorders[3].

Q: Which regions are expected to drive the growth of the haloperidol decanoate market? A: The market growth is expected to be driven by regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[3].

Q: What are the key side effects associated with haloperidol decanoate compared to paliperidone palmitate? A: Haloperidol decanoate is associated with more akathisia but less weight gain and lower serum prolactin levels compared to paliperidone palmitate[1].

Sources

1. Effectiveness of Paliperidone Palmitate vs Haloperidol Decanoate... - JAMA Network
2. Cost-Effectiveness of Long-Acting Injectable Paliperidone Palmitate... - PubMed
3. Global Haloperidol Market Size, Trends and Projections - Market Research Intellect
4. Haloperidol Decanoate API - Global Market Insights and Sales... - QY Research
5. Janssen Pharmaceuticals - Wikipedia