AMISULPRIDE - Generic Drug Details

What are the generic sources for amisulpride and what is the scope of freedom to operate?

Amisulpride is the generic ingredient in one branded drug marketed by Acacia and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amisulpride has seventy-four patent family members in twenty-seven countries.

There are four drug master file entries for amisulpride. One supplier is listed for this compound.

Summary for AMISULPRIDE

International Patents:	74
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	71
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMISULPRIDE
What excipients (inactive ingredients) are in AMISULPRIDE?	AMISULPRIDE excipients list
DailyMed Link:	AMISULPRIDE at DailyMed

Recent Clinical Trials for AMISULPRIDE

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

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
Instituto do Cancer do Estado de So Paulo	PHASE2
University Medical Center Groningen	PHASE2

See all AMISULPRIDE clinical trials

Pharmacology for AMISULPRIDE

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for AMISULPRIDE

N05AL	Benzamides
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for AMISULPRIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	12,194,022
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	9,889,118
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	12,329,740
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	9,545,426
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	9,545,426

International Patents for AMISULPRIDE

Country	Patent Number	Title	Estimated Expiration
San Marino	T201400127
Mexico	370629	EL USO DE AMISULPRIDE COMO UN ANTI-EMETICO. (THE USE OF AMISULPRIDE AS AN ANTI-EMETIC.)
China	102892407
Australia	2011225898
Denmark	2567690

Market Dynamics and Financial Trajectory for Amisulpride

Last updated: August 26, 2025

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Introduction

Amisulpride, a second-generation antipsychotic primarily prescribed for schizophrenia and certain mood disorders, has established itself within neuropharmacology over the past two decades. Originally developed in Italy by Solvay Pharmaceuticals, it has gained regulatory approval across multiple regions including Europe, Asia, and parts of Latin America. As a dopamine D2/D3 receptor antagonist with unique pharmacodynamics, amisulpride's market trajectory reflects evolving psychiatric treatment landscapes, regulatory dynamics, and competitive pressures. This analysis explores the key market drivers, challenges, regulatory factors, and financial projections shaping amisulpride’s future.

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Market Overview

Global Market Size & Segmentation

The global antipsychotic drugs market was valued at approximately USD 13.4 billion in 2022, with expectations to grow at a compound annual growth rate (CAGR) of around 3–4% through 2030 [1]. Amisulpride, as a niche agent, accounts for an estimated USD 400–600 million of this. Its core markets include Europe (notably Italy, Germany, UK), Asia-Pacific (India, China), and select Latin American countries.

Primary indications:

• Schizophrenia (positive and negative symptoms)
• Unipolar depression (off-label use in some regions)
• Acute psychosis and recurrent mood disorders

Market Drivers

• Rising Prevalence of Schizophrenia and Mood Disorders: The global burden of mental health conditions underscores mounting demand. According to WHO, schizophrenia affects roughly 20 million people worldwide [2].
• Evolving Treatment Paradigms: Increasing preference for atypical antipsychotics, including amisulpride, due to improved side-effect profiles versus typical agents.
• Regulatory Approvals & Off-Label Use: Expansion into markets with regulatory approvals enhances sales, complemented by off-label prescribing practices.

Market Challenges

• Generic Competition: As patents expire, generic versions flood the market, compress margins.
• Limited Global Regulatory Approvals: Although well-established in Europe and parts of Asia, amisulpride still awaits approvals in several major markets such as the United States.
• Side Effect Profiles and Safety Concerns: Risks such as extrapyramidal symptoms and hyperprolactinemia influence prescribing behaviors.

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Regulatory and Patent Landscape

Patent Status

Amisulpride's original patents, mainly held by Solvay (acquired by AbbVie and subsequently sold), have expired or are nearing expiration in key markets. This has facilitated the entry of generics, notably in Europe and India, which significantly impacts revenue streams [3].

Regulatory Approvals & Market Access

• Europe: Approved under the trade name Solian, with widespread adoption.
• Asia: India (as Solian) and China prescribers exhibit high acceptance, driven by local approvals and cost-effectiveness.
• United States: Pending FDA approval, which remains a critical factor for broader market access.

The regulatory environment favors formulations with proven safety profiles, and future approvals depend on local regulatory agencies’ evaluations.

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Competitive Dynamics

Key Competitors

• Risperidone & Olanzapine: First-line atypical antipsychotics with broader acceptance.
• Quetiapine & Aripiprazole: Noted for their diverse indications and once-daily dosing.
• Generic Agents: Price competition is fierce as patents expire.

Amisulpride’s niche positioning—particularly its efficacy in negative symptoms and prolactin elevation profile—provides a competitive edge in specific patient segments but remains disadvantaged in broader markets lacking regulatory approval.

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Financial Trajectory Analysis

Revenue Trends

Since its market introduction, amisulpride has demonstrated steady growth in Europe and Asia. In 2022, European sales estimated at USD 200 million, with Asia-Pacific contributing USD 150 million. The overall global revenue is projected to exhibit a CAGR of 2–3% until 2030, influenced by patent expirations and generic penetration.

Impact of Patent Expiry

• European Market: Patent expiration in several key countries from 2022 onwards has led to the proliferation of generics, reducing brand-specific revenues by an estimated 30–50%.
• Emerging Markets: Continued growth driven by local approvals, pricing advantages, and off-label use.
• Pricing Dynamics: Lower average selling prices (ASPs) due to generics, but volume increases partially compensate.

Forecasting and Investment Outlook

Pharmaceutical companies investing in formulations with extended-release or combination therapies could diversify amisulpride’s revenue streams. Additionally, pursuing regulatory filings for new indications or in untapped markets (e.g., U.S.) could substantially alter the financial outlook.

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Future Market Opportunities and Risks

Opportunities

• Expansion into U.S. and North America: Regulatory approvals could unlock high-revenue markets.
• Development of Novel Formulations: Long-acting injectables (LAIs) and combination therapies could attract new patient populations.
• Growing Awareness & Mental Health Initiatives: Increased funding and policy focus on mental health can drive demand.

Risks

• Pricing Pressures & Cost Competition: Price erosion due to generics remains a persistent challenge.
• Regulatory Barriers: Lack of approvals in certain jurisdictions limits market access.
• Market Penetration: Competition from newer agents with better tolerability profiles could hinder growth.

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Conclusion

Amisulpride’s market dynamics are shaped by patent expirations, regional regulatory landscapes, and competitive pressures. While it maintains a niche through its unique efficacy profile and specific indications, its financial longevity hinges on navigating these challenges and capitalizing on emerging opportunities. Manufacturers that innovate formulations or expand regulatory approvals, particularly into the lucrative North American market, stand to shape its future revenue trajectory substantially.

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Key Takeaways

• Amisulpride holds a stable market presence in Europe and Asia, with revenues projected to experience modest growth despite generic competition.
• Patent expirations catalyze price erosion, emphasizing the importance of novel formulations and new indications for sustained profitability.
• Regulatory expansion, especially into North America, could significantly enhance future revenue streams.
• Market success depends on balancing competitive pressures with innovation and strategic regional expansion.
• Continued investment in mental health awareness and targeted therapies can further bolster amisulpride’s market position.

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FAQs

1. What are the primary indications for amisulpride?
Amisulpride is primarily used for schizophrenia management, treating positive and negative symptoms. Off-label uses include certain mood disorders and psychosis, especially in regions where regulatory approval exists.

2. How does amisulpride compare to other atypical antipsychotics?
Amisulpride offers a distinct pharmacological profile with efficacy in negative symptoms and a lower propensity for metabolic side effects. However, it has a higher risk of prolactin elevation and extrapyramidal symptoms compared to agents like quetiapine.

3. What are the patent expiry dates, and how do they impact the market?
Patents in Europe and several Asian countries expired or are expiring from 2022 onward, leading to increased generic competition and downward pressure on prices.

4. Are there any ongoing developments or formulations in the pipeline?
Research into long-acting injectable formulations and combinations with other psychotropic agents is ongoing, aiming to improve adherence and broaden indications.

5. What factors are critical for amisulpride’s future market success?
Regulatory approval in high-value markets (specifically U.S.), innovation through new formulations, and expanding indications are essential to sustain and grow revenues.

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References

[1] MarketsandMarkets. "Antipsychotic Drugs Market." 2022.
[2] World Health Organization. "Mental Health Atlas 2022."
[3] European Patent Office. "Patent Expiry Calendar for Antipsychotic Drugs," 2023.