You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

HALOPERIDOL DECANOATE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Haloperidol Decanoate, and what generic alternatives are available?

Haloperidol Decanoate is a drug marketed by 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 twelve NDAs.

The generic ingredient in HALOPERIDOL DECANOATE 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 Decanoate

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for HALOPERIDOL DECANOATE?
  • What are the global sales for HALOPERIDOL DECANOATE?
  • What is Average Wholesale Price for HALOPERIDOL DECANOATE?
Summary for HALOPERIDOL DECANOATE
Drug patent expirations by year for HALOPERIDOL DECANOATE
Drug Prices for HALOPERIDOL DECANOATE

See drug prices for HALOPERIDOL DECANOATE

Drug Sales Revenue Trends for HALOPERIDOL DECANOATE

See drug sales revenues for HALOPERIDOL DECANOATE

Recent Clinical Trials for HALOPERIDOL DECANOATE

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

SponsorPhase
Case Western Reserve UniversityPhase 3
National Institutes of Health (NIH)Phase 3
National Institute of Mental Health (NIMH)Phase 3

See all HALOPERIDOL DECANOATE clinical trials

Pharmacology for HALOPERIDOL DECANOATE
Anatomical Therapeutic Chemical (ATC) Classes for HALOPERIDOL DECANOATE

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
Fresenius Kabi Usa HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893-001 Dec 19, 1997 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Somerset Theraps Llc HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 209101-002 Jul 3, 2018 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075176-001 Feb 9, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 205241-002 May 12, 2017 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 214507-002 Jul 26, 2021 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075393-002 May 11, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075176-002 Feb 9, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.