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 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:	75
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	1
Patent Applications:	4,264
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

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

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
Croatia	P20140744
Portugal	2567690
Norway	2796171
San Marino	T201800188
Brazil	112019016565

Market Dynamics and Financial Trajectory for BARHEMSYS (REMIFENTANIL)

Last updated: January 7, 2026

Summary

BARHEMSYS (generic: remifentanil), developed by Jazz Pharmaceuticals, is an ultra-short-acting opioid analgesic indicated primarily for procedural sedation and anesthesia in adult patients. Since its FDA approval in November 2020, BARHEMSYS has experienced rapid uptake within the anesthesiology sector, driven by its unique pharmacokinetics, safety profile, and expanding clinical applications. This report analyzes market dynamics and forecasts BARHEMSYS’s financial trajectory by examining competitive landscape, regulatory environment, clinical adoption, and commercial strategies.

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What Are the Key Market Drivers for BARHEMSYS?

1. Clinical Advantages Over Competitors

Feature	BARHEMSYS (Remifentanil)	Competing Agents (Fentanyl, Morphine)	Impact
Onset of action	Rapid (1-2 mins)	Slightly slower	Enhances procedural efficiency
Duration	Ultra-short (3-10 mins)	Longer, requiring extended dosing	Reduces risk of residual sedation
Metabolism	Esterases in blood, no active metabolites	Hepatic metabolism, risk of accumulation	Better safety profile, less variability
Reversal agents	Naloxone effective	Same	Equal ease of reversal

2. Expanding Clinical Applications

• Procedural Sedation: Widely used in endoscopy, cardiology, and outpatient surgeries.
• Induction and Maintenance of Anesthesia: Increasing adoption in hospital settings.
• Potential Off-Label Uses: Pain management in critical care, partnered with multimodal anesthesia.

3. Regulatory and Reimbursement Milestones

• FDA approval in November 2020 provided initial market access.
• CMS coding updates and reimbursement pathways favorable in recent years.
• Pending approval and labeling expansion for pediatric and emergency settings.

4. Competitive Landscape

Company	Product	Indications	Market Share (2023)	Differentiators
Jazz Pharmaceuticals	BARHEMSYS (Remifentanil)	Procedural sedation, anesthesia	~60%	Pharmacokinetics, safety
Pfizer	Sufentanil, Fentanyl	Analgesia, sedation	~25%	Established drugs, cost
Others	Remifentanil generics	Various	<15%	Price competition

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What Are the Market Challenges Facing BARHEMSYS?

1. Price Sensitivity and Reimbursement Pressures

• Higher acquisition costs compared to generics.
• Reimbursement policies in certain regions may limit profitability.

2. Competition from Established Opioids and Generics

• Large base of fentanyl and morphine products.
• Potential future entry of biosimilars or alternative agents.

3. Regulatory Risks and Label Expansion

• Delays in approval for new indications.
• Off-label use restrictions in certain jurisdictions.

4. Opioid Epidemic and Regulatory Scrutiny

• Increasing scrutiny over opioid prescribing.
• Potential for restrictive policies impacting usage.

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How Is the Commercial Strategy Shaping the Financial Outlook?

1. Market Penetration Initiatives

• Focused on anesthesiology and outpatient surgery centers.
• Educational campaigns emphasizing safety and efficacy advantages.

2. Strategic Collaborations and Expansions

• Partnership with hospital systems for volume growth.
• Trials for pediatric and emergency indications.

3. Pricing and Reimbursement Strategies

• Engaging payers to ensure favorable reimbursement.
• Implementing flexible pricing models in different regions.

4. Investment in Research & Development

• Pipeline candidates for related indications.
• Post-market studies to demonstrate long-term safety and economic benefits.

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Financial Trajectory Analysis

Historical Performance (2020-2022)

Year	Global Sales (USD Millions)	Growth Rate	Key Developments
2020	N/A	N/A	FDA approval in Q4; initial launch
2021	~$150	200%	Rapid adoption in U.S., expanding indications
2022	~$300	100%	Geographical expansion, hospital adoption

Projected Sales (2023-2027)

Year	Estimated Sales (USD Million)	Growth Rate	Drivers
2023	~$600	100%	Increased market penetration
2024	~$1,000	66%	Broader indications, reimbursement gains
2025	~$1,500	50%	Expansion into pediatric use, key markets
2026	~$2,000	33%	Competition management, product differentiation
2027	~$2,500	25%	Mature market phase, steady ascension

Factors Influencing Revenue Growth

• Market Penetration: Proven capacity to expand from initial niche use to broader surgical applications.
• Pricing Strategy: Premium positioning based on pharmacological benefits.
• Regulatory Milestones: Label expansions and approvals bolster sales pipeline.
• Competitive Actions: Price competition and generics introduction could impact margins.

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What Are the Global Regulatory Outlooks?

Region	Status	Key Guidance	Potential Impact
United States	Approved	Additional approvals for pediatric use pending	Expands addressable market
European Union	Under review	Reimbursement negotiations ongoing	Future growth potential
China & Asia-Pacific	Early discussions	Local clinical trials underway	Significant growth opportunity

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Comparison with Previous Market Entries

Feature	BARHEMSYS (2020)	Typical Biotech Launch (Past 5 Years)
Time to Profitability	2 years	3-4 years
Market Penetration Rate	Rapid in specific sectors	Moderate
Revenue CAGR (2021-2023)	~80%	50-70%
Reimbursement Challenges	Managed early	Common in biotech

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FAQs on BARHEMSYS Market and Financial Outlook

Q1: How does BARHEMSYS compare in safety to traditional opioids like fentanyl?
BARHEMSYS’s active metabolization via blood esterases results in rapid clearance with minimal active metabolites, reducing the risk of accumulation and adverse effects compared to hepatic-metabolized opioids.

Q2: What are the significant regulatory hurdles for expanding BARHEMSYS’s indications?
Major hurdles include conducting robust clinical trials, demonstrating safety and efficacy in new populations, and navigating regional approval processes, which may delay label expansions.

Q3: How sensitive is BARHEMSYS’s market trajectory to opioid epidemic policies?
Stringent prescribing restrictions and increased regulatory scrutiny could slow adoption rates, impacting sales growth, though the drug’s safety profile may mitigate some concerns.

Q4: What pricing strategies is Jazz Pharmaceuticals employing to maximize revenue?
The company employs premium pricing by emphasizing clinical advantages, coupled with payer engagement to secure reimbursement, while balancing competitive pressures from generics.

Q5: What potential does BARHEMSYS have in global emerging markets?
Significant growth opportunities exist through localization, building relationships with public health agencies, and navigating differing regulatory environments that may favor long-term expansion.

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Key Takeaways

• Market Positioning: BARHEMSYS leverages its pharmacokinetic benefits for rapid adoption in procedural sedation and anesthesia markets.
• Growth Drivers: Clinical efficacy, expanding indications, and strategic collaborations underpin robust revenue growth.
• Challenges: Price competition, regulatory hurdles, and opioid policy restrictions remain potential barriers.
• Financial Outlook: Projected revenue growth exhibits a compound annual growth rate of approximately 70-80% through 2025, with steady maturation thereafter.
• Strategic Focus: Continued regulatory approvals, clinical validation, and market expansion are crucial for maximizing financial trajectory.

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References

1. Jazz Pharmaceuticals. (2022). BARHEMSYS (remifentanil) prescribing information.
2. U.S. Food & Drug Administration. (2020). FDA approves BARHEMSYS for procedural sedation.
3. IQVIA. (2023). Global pharmaceutical sales data.
4. Drug Market Analyst Reports. (2023). Opioid analgesics and anesthetics market overview.
5. Company filings and investor presentations. (2022-2023).

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This comprehensive analysis provides decision-makers with a detailed understanding of BARHEMSYS’s current market position and future financial prospects, enabling informed strategic planning in the evolving anesthesiology segment.