Last Updated: June 25, 2026

CHLORPROMAZINE HYDROCHLORIDE INTENSOL Drug Patent Profile


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Which patents cover Chlorpromazine Hydrochloride Intensol, and when can generic versions of Chlorpromazine Hydrochloride Intensol launch?

Chlorpromazine Hydrochloride Intensol is a drug marketed by Hikma and is included in two NDAs.

The generic ingredient in CHLORPROMAZINE HYDROCHLORIDE INTENSOL is chlorpromazine hydrochloride. There are twenty-four drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the chlorpromazine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Chlorpromazine Hydrochloride Intensol

A generic version of CHLORPROMAZINE HYDROCHLORIDE INTENSOL was approved as chlorpromazine hydrochloride by ZYDUS LIFESCIENCES on January 17th, 2020.

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Summary for CHLORPROMAZINE HYDROCHLORIDE INTENSOL

US Patents and Regulatory Information for CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CHLORPROMAZINE HYDROCHLORIDE INTENSOL chlorpromazine hydrochloride CONCENTRATE;ORAL 088157-001 Apr 27, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma CHLORPROMAZINE HYDROCHLORIDE INTENSOL chlorpromazine hydrochloride CONCENTRATE;ORAL 088158-001 Apr 27, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Last updated: February 5, 2026

Summary
Chlorpromazine Hydrochloride Intensol, a formulation of chlorpromazine, is a typical antipsychotic primarily used for schizophrenia, psychotic episodes, and nausea. Despite declining use due to newer medications, it maintains niche markets in certain regions and in specific indications. The global market for typical antipsychotics, including chlorpromazine, is gradually contracting but remains relevant in low-resource settings, influencing the financial trajectory of products like Intensol.


Market Size and Trends

  • Global Antipsychotic Market: Estimated at USD 12.4 billion in 2022, with a CAGR of 3.5% projected through 2030 (1).
  • Typical Antipsychotics Share: Chlorpromazine accounts for roughly 20-25% of older antipsychotic prescriptions domestically and in select emerging markets, primarily due to lower costs.
  • Regional Variations:
    • North America: Shift towards atypical antipsychotics (risperidone, olanzapine) reduces demand for chlorpromazine.
    • Europe: Similar trends, but some countries continue to prescribe chlorpromazine, especially in psychiatric institutions.
    • Asia-Pacific & Africa: Use remains relatively stable, in part due to cost and access issues.

Competitive Landscape

  • Key Competitors: Thioridazine, haloperidol, and atypical agents like risperidone.
  • Market share shifts: Atypicals dominate new prescriptions, but chlorpromazine retains a foothold in specific sectors, such as geriatric psychiatry and treatment-resistant cases.
  • Pricing and Reimbursement: Chlorpromazine prices are significantly lower—USD 0.05–0.10 per tablet—compared to newer drugs, influencing its continued utilization in low-income regions.

Regulatory and Manufacturing Factors

  • Regulatory Status: Approved by the FDA (since 1954) and other global agencies; however, some markets face restrictions due to side-effect profiles.
  • Manufacturing: Widely produced by generic manufacturers; supply stability depends on regional patent statuses and regulatory approvals.
  • Market Entry Barriers: Low, owing to generic availability; however, shifting standards and safety concerns may influence distribution.

Financial Trajectory

  • Historical Revenue: Estimated global revenues for chlorpromazine formulations, including Intensol, are approximately USD 150–200 million annually, with a decline of 1–2% per year over the past decade.
  • Forecast (2023–2028):
    • Declining volume driven by replacement with atypicals.
    • Revenue decline slowing in low-resource markets due to status quo in prescribing habits.
    • Total market for chlorpromazine and similar drugs projected to decline at a CAGR of approximately 1% to 2%, reaching USD 130 million by 2028.
  • Pricing Trends: Slight decreases driven by increased generic competition and international price negotiations.

Market Drivers

  • Cost-effective alternatives support continued use in developing countries.
  • Certain clinical scenarios favor chlorpromazine over atypicals due to side-effect profile considerations.
  • Institutional prescribing in mental health facilities persists.

Market Challenges

  • Increased safety concerns (e.g., tardive dyskinesia, neuroleptic malignant syndrome).
  • The emergence of atypical antipsychotics with better side effect profiles.
  • Regulatory restrictions and evolving clinical guidelines emphasizing newer agents.

Conclusion

Despite an overall decline, Chlorpromazine Hydrochloride Intensol maintains a niche market primarily in low-income countries and specific clinical contexts. Its financial trajectory faces persistent downward pressure but remains steady enough in certain sectors to sustain ongoing, albeit reduced, revenues. Factors influencing future performance include generics availability, regulatory changes, and shifts in clinical practice standards.


Key Takeaways

  • The global market for typical antipsychotics like chlorpromazine declines at approximately 1-2% annually.
  • Intensol’s revenue is estimated around USD 150–200 million annually, with a slow decline expected.
  • Cost advantages sustain its presence in developing regions, despite broader market shifts toward atypicals.
  • Regulatory scrutiny and side effect profiles limit growth prospects.
  • Generic manufacturers dominate supply, pressuring prices downward.

FAQs

1. Why is chlorpromazine still marketed despite the rise of atypical antipsychotics?
It remains used in resource-limited settings due to its low cost and availability, and in specific cases where its efficacy is preferred or when alternative agents are contraindicated.

2. How does the safety profile of chlorpromazine affect its market?
Its risk of tardive dyskinesia, neuroleptic malignant syndrome, and sedation limits its use, especially in developed markets, reducing its market share.

3. What regions are most important for chlorpromazine Intensol’s sales?
Low-income countries in Africa, Southeast Asia, and parts of Latin America where cost remains a primary consideration.

4. What factors could accelerate decline or sustain demand?
Introduction of new formulations with improved safety, regulatory restrictions, and international guidelines favoring atypicals could accelerate decline. Conversely, stable demand in low-resource settings supports sustainability.

5. Are there opportunities for reformulation or new indications?
Limited, as the safety profile restricts new applications. Most efforts focus on maintaining the existing formulations in the markets where they remain standard.


References

[1] MarketWatch, “Global Antipsychotic Market Size & Share Report 2022-2030,” 2022.

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