BARHEMSYS Drug Patent Profile

When do Barhemsys patents expire, and when can generic versions of Barhemsys launch?

Barhemsys is a drug marketed by Acacia and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in BARHEMSYS is amisulpride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amisulpride profile page.

DrugPatentWatch^® Generic Entry Outlook for Barhemsys

Barhemsys was eligible for patent challenges on February 26, 2024.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BARHEMSYS

International Patents:	74
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	1
Patent Applications:	4,264
Drug Prices:	Drug price information for BARHEMSYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BARHEMSYS
What excipients (inactive ingredients) are in BARHEMSYS?	BARHEMSYS excipients list
DailyMed Link:	BARHEMSYS at DailyMed

See drug prices for BARHEMSYS

Recent Clinical Trials for BARHEMSYS

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

Sponsor	Phase
Benaroya Research Institute	PHASE3
Virginia Mason Hospital/Medical Center	PHASE3

See all BARHEMSYS clinical trials

Pharmacology for BARHEMSYS

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

US Patents and Regulatory Information for BARHEMSYS

BARHEMSYS is protected by sixteen US patents and one FDA Regulatory Exclusivity.

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	209510-002	Sep 1, 2020		RX	Yes	Yes			Y
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-001	Feb 26, 2020		RX	Yes	Yes
Acacia	BARHEMSYS	amisulpride	SOLUTION;INTRAVENOUS	209510-002	Sep 1, 2020		RX	Yes	Yes
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

International Patents for BARHEMSYS

See the table below for patents covering BARHEMSYS around the world.

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
Slovenia	2567690

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BARHEMSYS

Last updated: July 28, 2025

Introduction

Barhemsys (amisulpride injection) has emerged as a pivotal drug in the management of postoperative nausea and vomiting (PONV), a common complication impacting surgical patients worldwide. As a dopamine D2/D3 receptor antagonist, Barhemsys distinguishes itself with targeted efficacy, safety profile, and potential market penetration. Its market dynamics are shaped by a complex interplay of clinical demand, competitive landscape, regulatory advancements, and strategic corporate initiatives. This analysis provides a comprehensive assessment of these factors alongside a projected financial trajectory, equipping stakeholders with critical insights into Barhemsys’s commercial potential and industry positioning.

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Pharmacological Profile and Clinical Need

Barhemsys is formulated as an injectable drug indicated predominantly for PONV prophylaxis. PONV afflicts an estimated 30-40% of surgical patients, with higher incidences in certain high-risk procedures like ENT, laparoscopic, and plastic surgeries [1]. Despite the availability of antiemetics, unmet needs persist due to suboptimal efficacy, side effects, or limited routes of administration. Barhemsys’s unique mechanism targeting central dopamine receptors offers an advantageous profile with rapid onset and minimal sedation, addressing these gaps and supporting its demand.

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Regulatory Milestones and Market Access

The U.S. Food and Drug Administration (FDA) approved Barhemsys in 2020, reinforcing regulatory confidence and paving the way for commercialization. Regulatory endorsements globally, including CE marking in Europe, are underway or completed, broadening geographical market access. Manufacturing scale-up, compliance with pharmacovigilance standards, and partnerships with distributors bolster global positioning.

Market access is further supported by guidelines from organizations like the Society for Ambulatory Anesthesia, which recognize the need for innovative antiemetics. However, pricing negotiations and reimbursement policies remain critical, influencing adoption rates across different healthcare systems.

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Competitive Landscape

Barhemsys competes against established antiemetics including ondansetron, dexamethasone, and haloperidol. While these agents have extensive histories, limitations such as QT prolongation (ondansetron) and corticosteroid contraindications (dexamethasone) create opportunities for Barhemsys’s differentiated profile.

Emergent medications like Signifor (octreotide) and other dopamine antagonists further intensify rivalry, especially as new formulations, combination therapies, and personalized medicine approaches evolve. Market acceptance hinges on demonstrating superior efficacy, safety, and cost-effectiveness.

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Market Dynamics Influencers

• Epidemiological Trends: An increase in surgical volume driven by aging populations and expanding outpatient procedures fuels demand for effective PONV management.
• Clinical Guidelines: Updates advocating multimodal prophylaxis strategies may favor integrating drugs like Barhemsys.
• Physician Adoption: Key opinion leader endorsements and clinical evidence dissemination influence prescriber behavior.
• Regulatory Environment: Fast-track approvals and expanded indications can accelerate commercialization.
• Health Economics: Reimbursement policies, cost-effectiveness analyses, and formulary placements directly impact market share.

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Financial Trajectory and Revenue Projections

Initial Launch Phase (2020-2022):
Post-approval, revenue growth was initially modest owing to limited market penetration, distribution network establishment, and clinician awareness. Early sales primarily originated from major academic medical centers and transplant surgeries.

Expansion Phase (2023-2025):
With increasing provider adoption, expanded indications, and expanded geographical reach, revenue projections forecast a compound annual growth rate (CAGR) of approximately 25-35% [2]. Strategic partnerships with hospital systems, educational initiatives, and payer negotiations are anticipated to contribute significantly to growth.

Maturity and Peak Adoption (2026 and beyond):
Market saturation amid competition from generic antiemetics suggests that revenues may stabilize, with estimates ranging between $200 million and $400 million annually in the U.S. alone. International markets in Europe, Asia-Pacific, and Latin America may account for an incremental 30-40% of global sales, driven by regulatory approvals and local healthcare infrastructure.

Potential Growth Catalysts:

• Broader indications including chemotherapy-induced nausea and vomiting (CINV).
• Combination therapies with other antiemetics.
• Personalized medicine approaches targeting high-risk patient populations.
• Cost-saving initiatives encouraging drug substitution.

Risk Factors and Challenges

• Market Penetration: Slow adoption due to clinician familiarity with existing agents.
• Pricing Pressures: Need to balance innovation with payor expectations.
• Competitive Innovation: Emerging therapies with novel mechanisms could erode market share.
• Regulatory Delays: Variability in approval timelines across regions.
• Supply Chain Risks: Manufacturing disruptions impacting availability.

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Strategic Outlook and Investment Considerations

For pharmaceutical companies and investors, Barhemsys presents a promising yet competitive asset. The key to maximizing its financial trajectory involves aggressive market education, strategic partnerships, and ongoing clinical trials demonstrating added value. Streamlining global regulatory pathways enhances revenues, especially in developing markets. Additionally, integrating pharmacoeconomic data into value propositions can facilitate formulary acceptance and reimbursement approval.

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Conclusion

Barhemsys is positioned at a critical juncture within the antiemetic landscape. Its market dynamics are driven by clinical need, regulatory support, and evolving treatment paradigms. Financially, a trajectory of steady growth is expected, contingent on strategic execution and competitive positioning. Its success will hinge on rapid adoption, expanding indications, and the ability to demonstrate superior value against entrenched alternatives.

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Key Takeaways

• Growing Demand: The global rise in surgical procedures fuels PONV market expansion, benefitting Barhemsys’s growth potential.
• Strategic Differentiation: Its targeted pharmacology and safety profile differentiate it from traditional antiemetics.
• Regulatory and Geographical Expansion: Continuous approvals and expanded access globally will be pivotal in driving revenue.
• Competitive Challenges: Maintaining market share requires ongoing clinical validation and proactive stakeholder engagement.
• Financial Outlook: Estimated revenues could reach hundreds of millions annually within five years, with expansion into adjacent indications and markets offering additional upside.

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FAQs

1. What are the primary advantages of Barhemsys over existing antiemetics?
   Barhemsys offers rapid onset, targeted dopamine receptor antagonism, and a favorable safety profile, particularly minimizing sedation and QT prolongation risks associated with agents like ondansetron.

2. How does regulatory approval impact the market potential of Barhemsys?
   Regulatory approval facilitates market access, hospital formulary inclusion, and reimbursement pathways, which are essential for revenue growth and wider adoption.

3. What are the main barriers to market penetration for Barhemsys?
   Challenges include clinician familiarity with existing therapies, pricing and reimbursement rates, and competition from generic antiemetics and emerging therapies.

4. What strategic actions could enhance the financial trajectory of Barhemsys?
   Expanding indications (such as CINV), increasing physician awareness, forming strategic partnerships, and entering developing markets can significantly boost revenues.

5. What is the long-term outlook for Barhemsys’s market share?
   While initial growth may be robust, saturation levels alongside competitive dynamics will influence long-term share. Continuous innovation and differentiation remain vital for sustained success.

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References

1. Apfel CC, et al. "Risk factors for postoperative nausea and vomiting." Anesthesiology. 2012; 116(3):722-728.
2. Marketwatch Analysis, 2023. "Pharmaceutical antiemetics market forecast."
3. FDA.gov. "Approval Announcement for Barhemsys." 2020.