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-five 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2031. This may change due to patent challenges or generic licensing.

There have been nine 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:	75
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	1
Patent Applications:	4,587
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

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

NDA:

209510

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 BARHEMSYS

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

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

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for BARHEMSYS

When does loss-of-exclusivity occur for BARHEMSYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Norway

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2011225898
Brazil	112012022746
Canada	2792392
China	102892407
Cyprus	1115485
Cyprus	1115487

Barhemsys (dimenhydrinate injection): market dynamics and financial trajectory

Last updated: June 27, 2026

Barhemsys (dimenhydrinate injection; QINLOCK not relevant) has remained a small, specialty antiemetic product with limited uptake tied to hospital formulary adoption and ongoing payer scrutiny. Financial performance has tracked the size of its addressable market segment for chemotherapy-induced nausea and vomiting (CINV) prophylaxis, with pressure from generic alternatives in broader settings and from competing antiemetic regimens that dominate formularies.

What market dynamics have shaped Barhemsys sales?
Barhemsys is positioned for prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (MEC) and has historically relied on: (1) oncology center procurement behavior, (2) protocol-driven use by medical oncology and infusion units, and (3) bundling of antiemetic regimens that can reduce incremental use of a standalone product.

Key demand drivers

• Protocol dependence in oncology: Use is constrained by chemotherapy mix, line of therapy, and local antiemetic pathway standards (hospital-specific order sets).
• Formulary access: Adoption correlates with inclusion on hospital formularies and pharmacy benefit structures for infusion centers.
• Administration workflow fit: Barhemsys is an injection used in infusion settings, so uptake depends on compatibility with existing nursing and pharmacy workflows.
• Payer coverage and utilization management: Prior authorization or restricted coverage can slow conversions from competitors, especially when alternative antiemetic strategies are available at lower cost.

Key headwinds

• Therapeutic competition in CINV prophylaxis: Competing classes (NK1 antagonists, 5-HT3 antagonists, corticosteroid regimens) are entrenched in many pathways and can limit penetration for additional agents.
• Cost sensitivity at the hospital level: As antiemetic procurement economics tighten, purchasers favor regimens with favorable bundled acquisition costs and contracting.
• Limited differentiation outside its labeled niche: Barhemsys’ growth depends on continued use in the specific labeled scenario rather than broad substitution across antiemetic indications.

How has Barhemsys performed financially versus market expectations?
Barhemsys’ financial trajectory has been characterized by modest revenue generation consistent with a low-to-mid single product peak typical of specialty supportive-care brands. Its sales trajectory has not shown sustained acceleration into a high-volume blockbuster pattern, reflecting the constrained addressable market and the continued dominance of mainstream CINV protocols.

What matters in the revenue curve

• Early uptake is formulation- and site-dependent: Initial sales are sensitive to a limited number of hospitals and cancer centers converting from existing procurement habits.
• Conversion is slow in formularies: Once a pathway is set, switching costs and committee cadence delay expansion.
• Supply and contracting can dominate quarter-to-quarter variability: Small products show higher revenue volatility as contracts are renegotiated or patient mix shifts.

Revenue exposure points

• Infusion unit spend concentration: Sales are tied to oncology infusion throughput and procurement cycles, not retail prescribing.
• Net price compression pressure: As competition and contracting intensify, net revenue can compress even if gross demand holds.

What role do contracts, rebates, and wholesaler inventory play in Barhemsys reporting?
For hospital-infusion products, reported revenue reflects not only units sold but also wholesaler ordering patterns, contract pricing, and pharmacy benefit terms in institutional settings.

Common mechanisms that affect reported sales

• Quarterly contracting resets: Annual or semiannual renegotiations change effective net pricing and can swing net revenue.
• Wholesaler inventory effects: If distributors front-load orders, reported pharmacy/administration demand can look temporarily stronger.
• Rebate and discount structures: Larger accounts can secure discounts that reduce net realized price versus list.

Where does Barhemsys fit versus competing antiemetics?
Barhemsys competes within the supportive-care space for prevention of chemotherapy-related nausea and vomiting. Market share is determined less by marginal clinical differences and more by protocol positioning and cost.

Competitive landscape elements

• 5-HT3 antagonists: Widely used backbone agents for CINV prophylaxis.
• NK1 antagonists: Often added for high-risk regimens, limiting incremental use of additional supportive agents.
• Corticosteroids: Standard across many regimens, further shaping protocol selection.
• Generic dimenhydrinate options: Generic availability in parts of the supportive antiemetic market can cap price tolerance for broadly used agents.

How does Barhemsys compare with other CINV prophylaxis products in adoption mechanics?

• Adoption is site-by-site: Unlike heavily retail-indexed products, Barhemsys depends on each oncology center’s chemotherapy antiemetic pathway.
• Incrementality is limited: If a center already has an optimized prophylaxis protocol, Barhemsys is used only when it fits the pathway and procurement constraints.

What is the risk profile for Barhemsys from biosimilar and generic entry dynamics?
Barhemsys is not a biologic, so biosimilar risk does not apply. The relevant entry risk is generic or substitution risk within supportive antiemetics.

Generic and substitution risk channels

• Therapeutic substitution: Hospitals can substitute alternative antiemetic agents if clinically acceptable in their protocols.
• Procurement price competition: Even if Barhemsys retains formulary status, contract pricing can worsen relative economics.
• Tendering and group purchasing: GPO contracting can accelerate switching to lower-priced agents.

How do patent and exclusivity timelines drive market strategy for Barhemsys?
Barhemsys’ commercial strategy is shaped by patent and regulatory exclusivity around dimenhydrinate injection product-specific protection (formulation, method-of-use, or manufacturing process) if applicable. In hospital infusion supportive care, even when active ingredient competition exists, product-specific barriers can delay direct substitution.

What settlement or Paragraph IV events matter for Barhemsys?
For Barhemsys, market-facing outcomes in litigation would show up as: (1) delayed generic launch, (2) negotiated supply or distribution terms, or (3) accelerated erosion if exclusivity is not upheld. These events are typically reflected in revenue inflection points tied to generic entry timing.

What does FDA regulatory status imply for commercial trajectory?
Regulatory status affects:

• Label restriction: Any narrow scope constrains uptake.
• Label stability: If label expansion is not achieved, growth is capped by the original use case.
• Switching behavior: Safety and administration guidance can drive protocol acceptance, which in turn affects procurement.

Commercial commercialization: what procurement pathways determine adoption?
Barhemsys is primarily evaluated through institutional procurement:

• Formulary committee processes
• Oncology pathway standardization
• Drug acquisition cost and contract rates
• Pharmacy and nursing administration compatibility

How do these dynamics translate to sales durability?

• Products with limited differentiation tend to face a plateau once a modest installed base forms.
• Further growth requires either expanded protocol inclusion or favorable net contracting economics.

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Key Takeaways

• Barhemsys’ market dynamics are driven by oncology protocol fit, hospital formulary adoption, and institutional procurement economics rather than retail demand.
• Financial trajectory has followed a specialty-supportive pattern with modest scale, constrained by entrenched CINV prophylaxis regimens and cost sensitivity at the hospital level.
• Generic and substitution risk is the primary entry threat, since Barhemsys is not a biologic and does not face biosimilar dynamics.
• Revenue volatility and quarter-to-quarter variability are likely influenced by contracting cycles and wholesaler ordering patterns typical of hospital infusion products.

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FAQs

1) What is Barhemsys used for in chemotherapy nausea and vomiting prophylaxis?
Barhemsys is used for prevention of nausea and vomiting associated with moderately emetogenic chemotherapy, with use governed by oncology antiemetic pathways and hospital protocol standards.

2) Why do supportive-care injection drugs like Barhemsys struggle to reach blockbuster scale?
Their demand is protocol- and formulary-dependent, with incremental adoption limited when mainstay antiemetic regimens and generic alternatives are already embedded in institutional formularies.

3) How do hospital contracts affect Barhemsys net revenue more than gross demand?
Institutional contracting changes effective net pricing through rebates, discounts, and GPO arrangements, which can compress revenue even when utilization is stable.

4) Is Barhemsys exposed to biosimilar competition?
No. Biosimilar risk is not applicable because Barhemsys is not a biologic product.

5) What is the biggest commercial risk for Barhemsys over the next few years?
Generic or substitution-driven procurement pressure, combined with pathway standardization that limits incremental use beyond its labeled niche.

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References

1. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA labeling for Barhemsys (dimenhydrinate injection).