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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amisulpride has sixty-eight 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:	68
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	67
Patent Applications:	6,356
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:

NEW CHEMICAL ENTITY

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
The Affiliated Hospital of Qingdao University	Phase 1
Qilu Pharmaceutical (Hainan) Co., Ltd.	Phase 3
Amicus CD LLC	Phase 2/Phase 3

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
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes

International Patents for AMISULPRIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	030335	ПРИМЕНЕНИЕ АМИСУЛЬПРИДА В КАЧЕСТВЕ ПРОТИВОРВОТНОГО СРЕДСТВА (USE OF AMISULPRIDE AS AN ANTI-EMETIC)
China	110603036	术后恶心和呕吐的补救治疗 (RESCUE TREATMENT OF POST OPERATIVE NAUSEA AND VOMITING)
Israel	268591	טיפול מציל לאחר פעילות של בחילה והקאה (Rescue treatment of post operative nausea and vomiting)
Denmark	2796171

AMISULPRIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amisulpride

Introduction

Amisulpride, an antipsychotic medication, is a crucial component in the treatment of mental health conditions such as schizophrenia and bipolar disorder. The market for amisulpride and its derivatives, like amisulpride acid, is experiencing significant growth driven by several key factors. Here, we delve into the market dynamics, innovations, and financial trajectory of amisulpride.

Chemical and Pharmacological Properties

Amisulpride acid, a metabolite of amisulpride, plays a vital role in the drug's metabolic pathway. It has a complex molecular structure and exhibits a range of pharmacological effects that enhance the overall efficacy of amisulpride in treating mental illnesses[1].

Market Segments and Applications

The amisulpride market is segmented into various types and applications. The drug is available in different dosages (50mg, 200mg, 400mg tablets) and is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[4].

Types of Amisulpride

• Dosage Forms: Amisulpride is available in 50mg, 200mg, and 400mg tablets, catering to different patient needs[4].

Applications

• Schizophrenia and Bipolar Disorder: Amisulpride is primarily used to treat schizophrenia and bipolar disorder. Its effectiveness in these conditions has made it a preferred choice among healthcare providers[1][2].

Innovations and Trends

The amisulpride market is driven by several innovations and trends:

Extended-Release Formulations

• Recent advancements include the development of extended-release formulations, which improve patient compliance and reduce the frequency of dosing[1].

Combination Therapies

• Combination therapies involving amisulpride and other medications are being explored to enhance treatment outcomes for mental health conditions[1].

Technological Innovations

• Technological advancements in drug delivery systems are improving the efficacy and safety of amisulpride. For example, LB Pharmaceuticals is working on enhancing blood-brain barrier permeability for its amisulpride derivative, LB-102[2].

Strategic Partnerships and Mergers

The market is witnessing significant strategic partnerships and mergers that are driving growth:

LB Pharmaceuticals

• LB Pharmaceuticals, with its novel iteration of amisulpride (LB-102), has secured substantial funding, including a $75 million Series C round. This investment underscores investor confidence in the company's strategy and drug development pathway[2].

Major Acquisitions

• The schizophrenia treatment space has seen major acquisitions, such as Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics and AbbVie's $8.7 billion purchase of Cerevel Therapeutics, indicating a high level of activity and investment in this sector[2].

Financial Trajectory

The financial trajectory of the amisulpride market is promising, with several factors contributing to its growth:

Market Valuation

• The global amisulpride market was valued at a significant amount in 2023 and is anticipated to grow at a considerable CAGR until 2030[4].

Funding and Investments

• Companies like LB Pharmaceuticals have secured substantial funding for their research and development efforts. LB Pharmaceuticals has raised approximately $122 million, highlighting the financial support and confidence in the sector[2].

Cost-Effectiveness

• Studies have shown that amisulpride is a cost-effective option compared to other antipsychotics like olanzapine. For instance, in China, amisulpride provided an effectiveness gain of 16.59 QALYs at a lower cost than olanzapine, making it a financially viable treatment option[5].

Challenges

Despite the growth and opportunities, the amisulpride market faces several challenges:

Regulatory Hurdles

• The path to commercialization involves rigorous clinical testing and regulatory hurdles. Companies must navigate these challenges to bring new formulations to the market[2].

Competition

• The market is highly competitive, with many effective generics available. New entrants must differentiate their products significantly to gain market share[2].

Continuous Innovation

• The need for continuous innovation to address treatment limitations and improve patient outcomes is a constant challenge. Companies must invest in R&D to stay competitive[1].

Investment Opportunities

The amisulpride market presents several investment opportunities:

R&D Funding

• Funding R&D projects aimed at enhancing amisulpride formulations and delivery systems can be highly rewarding. Companies like LB Pharmaceuticals are already seeing significant returns on such investments[2].

Emerging Markets

• Expanding into emerging markets where there is a growing demand for mental health treatments can provide substantial growth opportunities[1].

Novel Formulations

• Developing novel formulations and delivery systems for amisulpride can attract investors looking for innovative solutions in the mental health treatment space[1].

Key Players

The amisulpride market is dominated by several key players:

Qilu Pharma

• Qilu Pharma is one of the main players in the amisulpride market, known for its robust product portfolio and market presence[4].

Sanofi

• Sanofi, which markets amisulpride under the brand name Solian, is another major player. Sanofi's legacy and market reach contribute significantly to the drug's global presence[2][4].

Vexxa Lifescience

• Vexxa Lifescience is also a notable player, contributing to the market's growth through its innovative products and distribution channels[4].

Future Outlook

The future of the amisulpride market looks promising, driven by increasing demand for mental health treatments, ongoing R&D, and the development of new formulations.

Growing Demand

• The increasing global demand for effective mental health treatments is a significant driver of the amisulpride market's growth[1].

Ongoing R&D

• Continuous research and development aimed at enhancing amisulpride's efficacy and safety will continue to drive innovation in the market[1].

New Formulations

• The development of new formulations, such as extended-release and combination therapies, will further expand the market's potential[1].

Key Takeaways

• Innovations: The amisulpride market is driven by innovations in pharmaceutical formulations, technological advancements, and strategic partnerships.
• Financial Growth: The market is expected to grow significantly, driven by increasing demand and ongoing R&D.
• Challenges: Regulatory hurdles, competition, and the need for continuous innovation are key challenges.
• Investment Opportunities: Funding R&D, expanding into emerging markets, and developing novel formulations present significant investment opportunities.
• Key Players: Qilu Pharma, Sanofi, and Vexxa Lifescience are major players in the amisulpride market.

FAQs

What are the primary applications of amisulpride?

Amisulpride is primarily used to treat schizophrenia and bipolar disorder.

Which companies are leading the amisulpride market?

Key players include Qilu Pharma, Sanofi, and Vexxa Lifescience.

What are the recent innovations in the amisulpride market?

Recent innovations include extended-release formulations, combination therapies, and technological advancements in drug delivery systems.

How cost-effective is amisulpride compared to other antipsychotics?

Amisulpride is likely to be a cost-effective option compared to other antipsychotics like olanzapine, especially in terms of quality-adjusted life years (QALYs)[5].

What are the main challenges facing the amisulpride market?

The main challenges include regulatory hurdles, intense competition from other medications, and the need for continuous innovation to address treatment limitations.

Sources

1. Market Research Intellect: Amisulpride Acid Market Dynamics: Innovations and Trends Shaping the Future of the Industry.
2. Bay Bridge Bio: LB Pharmaceuticals investment analysis.
3. MDPI: Modeling the Double Peak Phenomenon in Drug Absorption Kinetics.
4. Valuates Reports: Global Amisulpride Market Research Report 2024.
5. PubMed: Comparative cost-effectiveness of amisulpride and olanzapine in the treatment of schizophrenia patients in China.