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Last Updated: December 26, 2024

HALDOL SOLUTAB Drug Patent Profile


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When do Haldol Solutab patents expire, and when can generic versions of Haldol Solutab launch?

Haldol Solutab is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in HALDOL SOLUTAB is haloperidol. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Haldol Solutab

A generic version of HALDOL SOLUTAB was approved as haloperidol by MYLAN on June 10th, 1986.

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Summary for HALDOL SOLUTAB
Drug patent expirations by year for HALDOL SOLUTAB

US Patents and Regulatory Information for HALDOL SOLUTAB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm HALDOL SOLUTAB haloperidol TABLET;ORAL 017079-001 Approved Prior to Jan 1, 1982 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

HALDOL SOLUTAB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HALDOL SOLUTAB (Haloperidol)

Introduction to HALDOL SOLUTAB

HALDOL SOLUTAB, known generically as haloperidol, is a first-generation 'typical' antipsychotic medication used primarily for the treatment of schizophrenia and other psychiatric conditions such as schizoaffective disorder, moderate to severe manic episodes associated with bipolar I disorder, and acute psychomotor agitation[2][4].

Market Size and Growth Projections

The haloperidol market, which includes HALDOL SOLUTAB, is anticipated to experience significant growth over the forecast period from 2024 to 2031. The market is expected to develop revenue at a remarkable Compound Annual Growth Rate (CAGR) during this period. This growth is driven by increasing demand for antipsychotic medications and the expanding global healthcare market[1].

Market Segmentation

The haloperidol market is segmented based on several key factors:

By Type

  • Oral: This includes tablets, oral solutions, and dissolvable tablets like HALDOL SOLUTAB.
  • Injection: Haloperidol decanoate is used for long-acting injectable formulations[1][4].

By Application

  • Mental Disease: Primarily used for schizophrenia, schizoaffective disorder, and bipolar I disorder.
  • Others: Includes treatment for acute delirium, psychomotor agitation, and other psychiatric conditions[1][4].

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

Each of these segments provides a detailed analysis of market trends and growth prospects[1].

Key Drivers and Restraints

Drivers

  • Increasing Prevalence of Mental Health Disorders: The rising incidence of schizophrenia and other psychiatric conditions drives the demand for effective antipsychotic medications like haloperidol.
  • Global Healthcare Expansion: Improving healthcare infrastructure and access to medications in developing countries contribute to market growth.
  • Essential Medicine Status: Haloperidol is included in the World Health Organization’s List of Essential Medicines, ensuring its continued demand and availability[2][4].

Restraints

  • Side Effects and Safety Concerns: Haloperidol is associated with side effects such as extrapyramidal symptoms, which can limit its use in some patients.
  • Competition from Atypical Antipsychotics: Atypical antipsychotics like olanzapine often have better side effect profiles and may be preferred over typical antipsychotics like haloperidol[3][5].

Financial Trajectory

Revenue Projections

The haloperidol market is expected to generate significant revenue during the forecast period. The market size is measured in USD million, with projections indicating a substantial increase from 2024 to 2031[1].

Cost and Economic Outcomes

  • Treatment Costs: Studies have shown that while haloperidol may have lower medication acquisition costs compared to atypical antipsychotics, it can result in higher total treatment costs due to increased hospitalization rates and longer hospital stays[3][5].
  • Acquisition and Market Expansion: The acquisition of HALDOL by Essential Pharma in 2022 has strengthened the company's portfolio in CNS and neurological medicines, ensuring sustained supply and access to this essential medication globally[2].

Market Players and Competitive Landscape

Key Companies

  • Sandoz
  • Mylan
  • Teva
  • Fresenius Kabi
  • Gland Pharma
  • Zydus
  • Essential Pharma: Recent acquisition of HALDOL has expanded Essential Pharma’s global presence and strengthened its position in the CNS market[1][2].

Regulatory Environment

Harmonization in the EU

The European Medicines Agency (EMA) has harmonized the marketing authorizations for haloperidol across EU member states to ensure consistent use and labeling. This harmonization includes therapeutic indications, labeling, and package leaflets[4].

Clinical and Economic Outcomes

Comparative Studies

Studies comparing haloperidol with atypical antipsychotics like olanzapine have shown that while haloperidol may be more cost-effective in terms of medication acquisition, it often results in higher total medical costs due to increased hospitalization and treatment needs. Olanzapine, for example, has been associated with lower hospitalization rates and overall medical costs despite higher medication costs[3][5].

Global Market Presence

HALDOL SOLUTAB is marketed in over 60 countries across various regions, including the US, EMEA, Latin America, and the Asia-Pacific. This widespread presence underscores the global demand for this medication and its importance in psychiatric treatment[2].

Key Takeaways

  • Market Growth: The haloperidol market is expected to grow significantly from 2024 to 2031.
  • Segmentation: The market is segmented by type, application, and geography.
  • Drivers and Restraints: Increasing mental health disorders and global healthcare expansion drive the market, while side effects and competition from atypical antipsychotics are restraints.
  • Financial Trajectory: The market is projected to generate substantial revenue, with considerations for treatment costs and economic outcomes.
  • Regulatory Environment: Harmonization in the EU ensures consistent use and labeling.
  • Global Presence: HALDOL SOLUTAB is widely marketed across multiple regions.

FAQs

Q: What is HALDOL SOLUTAB used for?

A: HALDOL SOLUTAB, or haloperidol, is used for the treatment of schizophrenia, schizoaffective disorder, moderate to severe manic episodes associated with bipolar I disorder, and acute psychomotor agitation.

Q: Who acquired the rights to HALDOL in 2022?

A: Essential Pharma acquired the rights to HALDOL from Janssen Pharmaceutica NV in 2022.

Q: How is the haloperidol market segmented?

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

Q: What are the key drivers of the haloperidol market?

A: The key drivers include the increasing prevalence of mental health disorders and the global expansion of healthcare infrastructure.

Q: How does haloperidol compare to atypical antipsychotics in terms of cost?

A: While haloperidol may have lower medication acquisition costs, it often results in higher total treatment costs due to increased hospitalization rates compared to atypical antipsychotics like olanzapine.

Sources

  1. Global Haloperidol Market Size, Trends and Projections - Market Research Intellect
  2. Essential Pharma Announces the Acquisition of HALDOL - Financial Post
  3. A pharmacoeconomic analysis of atypical antipsychotics - PubMed
  4. Haldol - European Medicines Agency
  5. Clinical and economic outcomes of olanzapine compared with haloperidol - PubMed

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