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Last Updated: December 15, 2025

EQUANIL Drug Patent Profile


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When do Equanil patents expire, and what generic alternatives are available?

Equanil is a drug marketed by Wyeth Ayerst and is included in two NDAs.

The generic ingredient in EQUANIL is meprobamate. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the meprobamate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Equanil

A generic version of EQUANIL was approved as meprobamate by INVAGEN PHARMS on February 27th, 2008.

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  • What is the 5 year forecast for EQUANIL?
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Summary for EQUANIL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 33
Patent Applications: 4,724
DailyMed Link:EQUANIL at DailyMed
Drug patent expirations by year for EQUANIL

US Patents and Regulatory Information for EQUANIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst EQUANIL meprobamate CAPSULE;ORAL 012455-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst EQUANIL meprobamate TABLET;ORAL 010028-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst EQUANIL meprobamate TABLET;ORAL 010028-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 EQUANIL (Chlorpromazine)

Last updated: August 2, 2025

Introduction

EQUANIL, historically known by its generic name chlorpromazine, is a pioneering antipsychotic agent introduced in the 1950s. Originally developed as a treatment for schizophrenia and psychosis, EQUANIL revolutionized mental health therapy, establishing itself as a cornerstone in psychiatric pharmacopeia. Although its prominence has waned with the advent of second-generation antipsychotics, recent market and regulatory developments, along with emerging global mental health needs, influence its current and future financial trajectory.

Market Overview

The global antipsychotic drug market was valued at approximately USD 12.3 billion in 2022 and is projected to reach USD 16.5 billion by 2030, expanding at a CAGR of 3.7% (Grand View Research). The market is characterized by a mix of branded and generic products, with older formulations like chlorpromazine representing a significant share primarily due to their cost-effectiveness and established efficacy.

Historical Significance and Market Decline

Initially, EQUANIL enjoyed robust sales due to its effectiveness and low cost relative to newer antipsychotics. However, the introduction of second-generation agents such as risperidone, olanzapine, and aripiprazole—offering improved side effect profiles—diminished demand for first-generation drugs. Consequently, chlorpromazine's market share has declined substantially, with many formulations now operating within a generic landscape.

Current Market Dynamics

  1. Generic Dominance and Pricing Pressure

    As a patent-expired compound, chlorpromazine is produced by numerous generic manufacturers across global markets. Price competition has driven down unit costs, making it a cost-effective choice for healthcare systems, especially in low-to-middle-income countries.

  2. Off-Label and Alternative Uses

    Beyond schizophrenia, chlorpromazine finds off-label applications—such as in intractable hiccups, nausea, and behavioral agitation. While these uses provide niche markets, their contribution remains limited compared to primary psychiatric indications.

  3. Regional Market Variations

    • Developing Countries: Demand persists due to affordability and established clinical protocols.
    • Developed Markets: Prescriptions have decreased markedly, replaced by newer agents, although some psychiatric clinics continue to utilize chlorpromazine as a cost-effective alternative.
  4. Regulatory Environment

    Regulatory agencies focus heavily on safety and tolerability profiles. The side effect burden of chlorpromazine, including sedation, hypotension, and extrapyramidal symptoms, has led to stricter labeling and usage restrictions in certain regions, influencing its market availability and pricing.

  5. Supply Chain Considerations

    The manufacturing landscape primarily involves generic manufacturers in India, China, and Europe. Supply chain disruptions, especially during global crises like the COVID-19 pandemic, have temporarily impacted availability but have not fundamentally altered long-term market trends.

Financial Trajectory

Given its generic status, EQUANIL's revenue streams are relatively stable but limited. Its financial trajectory can be summarized as follows:

  • Revenue Stability in Developing Countries: Cost-sensitive markets sustain moderate sales, bolstered by government procurement programs.
  • Declining Market Share in Developed Countries: Due to pharmacological advancements, sales and prescriptions decline progressively.
  • Pricing Trends: Continual downward pressure, with prices stabilizing at low levels due to high competition.
  • Patent and Regulatory Impact: Patent expiry in most jurisdictions confirms the commoditization of chlorpromazine, limiting pricing power.

Future Outlook

Despite its plateaued clinical relevance in regions favoring newer agents, EQUANIL's market persists owing to its affordability and established efficacy. Potential growth vectors include:

  • Expanding Mental Health Needs Worldwide: Increasing awareness and diagnosis rates may sustain or slightly boost demand.
  • Use in Psychiatric Facilities in Emerging Markets: Cost-effective treatment options remain vital in resource-limited settings.
  • Development of Formulations with Improved Safety Profiles: Reformulations or combination therapies could revive interest.

However, the overall market tide suggests that EQUANIL's consultative value and financial prospects will remain modest in the medium term, subject to competitive pressures and regulatory scrutiny.

Regulatory and Competitive Considerations

The drug's trajectory faces constraints from stringent safety evaluations, especially given its side effect profile. The competitive landscape includes a broad array of newer antipsychotics with superior safety and tolerability. Nevertheless, EQUANIL maintains relevance where cost considerations outweigh newer drug profiles.

Conclusion

EQUANIL’s market dynamics reflect a classic pattern of first-generation pharmaceuticals entering a generics-driven phase, with regional variability significantly influencing sales. While its financial contribution is shrinking in high-income jurisdictions, it remains a cost-effective staple in global healthcare, particularly those with limited resources. The future of EQUANIL hinges on broader mental health initiatives and the ongoing need for affordable psychiatric medications rather than therapeutic innovation.


Key Takeaways

  • EQUANIL (chlorpromazine) has transitioned into a low-cost generic drug with stable, primarily regional demand.
  • Market decline driven by competition from second-generation antipsychotics and safety concerns.
  • Emerging markets sustain demand due to affordability, which buffers revenue decline.
  • New applications and formulary reforms might slightly influence future sales but are unlikely to reverse the overall downward trend.
  • Stakeholders should focus on regional dynamics, regulatory landscape, and cost factors when assessing EQUANIL’s financial prospects.

FAQs

1. Is EQUANIL still widely prescribed in modern psychiatric practice?
While its prescription has declined in developed countries, EQUANIL remains used in resource-limited settings and among clinicians seeking low-cost treatment options, particularly for certain off-label indications.

2. What are the main safety concerns associated with chlorpromazine?
Chlorpromazine's side effects include sedation, hypotension, weight gain, extrapyramidal symptoms, and anticholinergic effects, which have contributed to its decreased popularity.

3. How does the generic status of EQUANIL affect its market value?
As a generic, EQUANIL faces intense price competition, limiting profit margins but ensuring stable supply and continued use in cost-sensitive markets.

4. Are there any recent developments or reformulations of EQUANIL?
No significant reformulations or new indications have emerged recently; the drug remains essentially unchanged and is often used in its traditional form.

5. What role might emerging markets play in EQUANIL’s future?
Emerging markets' focus on affordability may sustain demand, especially where healthcare budgets are constrained and newer agents are prohibitively expensive.


Sources:

[1] Grand View Research. “Antipsychotic Drugs Market Size & Trends.” 2022.
[2] U.S. Food and Drug Administration. “Drug Approvals and Safety Reports.” 2023.
[3] World Health Organization. “Mental Health Atlas 2022.”
[4] PharmaTimes. “Generics Market Outlook 2023.”

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