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-five 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:	75
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:	72
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AMISULPRIDE

Constraining patent/regulatory exclusivity:

9,545,426

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AMISULPRIDE

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

Sponsor	Phase
Stanford University	EARLY_PHASE1
University Hospital, Strasbourg, France	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	209510-002	Sep 1, 2020		RX	Yes	Yes	9,084,765
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	12,005,042
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes	9,545,426
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes	12,329,740

International Patents for AMISULPRIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20130045241	THE USE OF AMISULPRIDE AS AN ANTI-EMETIC
New Zealand	602279	The use of amisulpride as an anti-emetic
Spain	2665418
European Patent Office	2796171

Market Dynamics and Financial Trajectory for Amisulpride

Last updated: March 14, 2026

What is the Current Market Position of Amisulpride?

Amisulpride is an atypical antipsychotic primarily prescribed for schizophrenia and related psychotic disorders. It belongs to the class of dopamine antagonists with high affinity for D2 and D3 receptors. It is marketed globally under brand names such as Solian, primarily in Europe and parts of Asia.

Global Market Size and Revenue

As of 2022, the global market for antipsychotics was estimated at approximately USD 12.5 billion. Amisulpride's market share is projected at 4-6%, equating to USD 0.5-0.75 billion, driven largely by sales in Europe, Australia, and select Asian countries.

Market Share Breakdown

Region	Estimated Market Share	Approximate Revenue (USD billion)	Remarks
Europe	50%	0.25-0.375	Largest market for amisulpride
Asia-Pacific	30%	0.15-0.225	Growing use in Japan, India, South Korea
North America	10%	0.05-0.075	Limited approval, small penetration
Rest of World	10%	0.05-0.075	Emerging markets

Key Market Dynamics

• Approval Status: Amisulpride is approved in the EU, Australia, and some Asian markets. It is not approved by the FDA, limiting access in the US.
• Competition: The drug faces competition from other atypical antipsychotics such as risperidone, olanzapine, quetiapine, and aripiprazole.
• Patent Status: Generic versions entered the European market in late 2010s, suppressing prices and impacting revenue.

What Are the Drivers and Challenges Impacting Its Financial Trajectory?

Drivers

1. Growing Prevalence of Schizophrenia: WHO estimates approximately 20 million people globally suffer from schizophrenia, increasing demand for antipsychotics.
2. Expanding Approval in Asian Markets: Countries like India and China have begun approving and prescribing amisulpride, expanding market bases.
3. Long-Term Treatment: Chronic nature of psychotic illnesses sustains steady demand, with some patients continuing therapy over years.

Challenges

1. Limited US Market: Absence of FDA approval constrains revenue potential in the largest pharmaceutical market.
2. Pricing Pressure: Generic competition since late 2010s has driven prices down, impacting profit margins.
3. Side Effect Profile: Compared to newer atypicals, amisulpride's side effects (e.g., extrapyramidal symptoms) may influence prescribing patterns.

How Will Market Trends Affect the Financial Outlook?

Short-Term Outlook (Next 2-3 Years)

• Slight growth expected in Asia-Pacific due to expanding approvals.
• Revenue decline anticipated in Europe owing to generic competition.
• No significant revenue shift expected in North America unless FDA approval is sought and granted.

Long-Term Outlook (3-10 Years)

• Market stagnation unless new formulations or indications are developed.
• Potential growth if new patents or formulations extend exclusivity or improve tolerability.
• Competitive pressure will likely continue to suppress margins unless differentiated through innovation.

What Is the Competitive Landscape?

Company	Drug	Market Presence	Key Advantages
Johnson & Johnson	Risperdal	Global, FDA-approved	Broad market access, established safety profile
Novartis	Clozaril (clozapine)	Global, FDA-approved	Effective for treatment-resistant cases
Commercial Applicants	Generic amisulpride	Global (post-patent)	Lower price point, increased accessibility

What Are the Regulatory and Policy Impacts?

• Patent Expirations: Generics since 2010s resulted in price erosion.
• Market Access: Expanded approvals outside Europe, notably in Japan (2018) and India (2020), present growth opportunities.
• Pricing Policies: Governments in many countries control drug prices, affecting revenue potential.

What Financial Metrics Are Relevant?

• Revenue: Estimated USD 0.5-0.75 billion in 2022 with a declining trend in Europe.
• Market Penetration Rate: Varies by region, higher in Europe, limited in North America.
• Revenue CAGR: Projected at approximately -2% in the next 3 years globally, stabilizing thereafter with regional growth.

Key Takeaways

• Amisulpride commands a niche in Europe and parts of Asia, with revenues impacted by generic competition.
• Expanded Asian approvals provide near-term growth prospects.
• US market absence constrains potential; regulatory approval remains crucial.
• Competition from newer atypical antipsychotics influences prescribing habits and overall sales.
• Long-term growth depends on innovations, patent strategies, or new indications.

FAQs

1. What are the main markets for amisulpride?
Europe and Asia-Pacific dominate due to regulatory approval and prescribing habits.

2. How does amisulpride compare to newer antipsychotics?
It has a more established safety profile but faces competition from drugs with fewer side effects and broader approval.

3. Can amisulpride's revenue grow without US approval?
Limited; US market presence is significant. Growth depends on approvals elsewhere and formulation innovations.

4. What are the regulatory hurdles for amisulpride?
Securing FDA approval and demonstrating safety and efficacy comparable to approved drugs remains key.

5. Are there patents protecting amisulpride?
Original patents expired in late 2010s; generic competition has entered various markets, reducing margins.

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References:

1. Statista. (2022). Global market size for antipsychotics.
2. European Medicines Agency. (2021). Amisulpride summary.
3. World Health Organization. (2019). Schizophrenia epidemiology.
4. IQVIA. (2022). Global prescription drug market analysis.
5. U.S. Food and Drug Administration. (2022). Antipsychotic approval updates.