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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 five patents protecting this drug.

This drug has sixty-eight 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 February 26, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BARHEMSYS

International Patents:	68
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Patent Applications:	4,249
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

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 nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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	209510-001	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
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

International Patents for BARHEMSYS

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

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
European Patent Office	2796171	Utilisation de l'amisulpride pour le traitement des nausées et vomissements induits par les opiacés (Use of amisulpride for treating opiated-induced nausea and vomiting)
Denmark	2567690

BARHEMSYS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Barhemsys

Introduction to Barhemsys

Barhemsys, developed by Acacia Pharma Group plc and acquired by Eagle Pharmaceuticals in 2022, is a significant addition to the pharmaceutical landscape. It is the first and only U.S. Food and Drug Administration (FDA)-approved antiemetic for the rescue treatment of postoperative nausea and vomiting (PONV) despite prophylaxis, as well as for the prevention of PONV in patients who have not received prophylaxis[3][4][5].

Market Opportunity

The total estimated annual U.S. addressable market for PONV prophylaxis and rescue is substantial, estimated at $2.7 billion. This presents a considerable market opportunity for Barhemsys, especially given its unique FDA-approved indication for PONV rescue after failed prophylaxis[4].

Sales Performance

In the second half of 2022, combined sales of Barhemsys and another acquired product, Byfavo, were $1.5 million, which represented a doubling from Acacia's reported net sales of $722,000 for these two products in the second half of 2021. This growth indicates a positive initial response to the product in the market[1][3].

For the second quarter of 2023, combined sales of Barhemsys and Byfavo were $1.2 million, showing approximately 30% sequential growth over the last two quarters. This sequential growth highlights the increasing adoption and sales momentum of Barhemsys[2][5].

Patient and Healthcare Facility Adoption

During the second quarter of 2023, an estimated 19,000 patients were dosed with Barhemsys or Byfavo, and 275 healthcare facilities purchased the products out of a total targeted market of approximately 4,000 facilities. This data suggests that Barhemsys is gaining traction among both patients and healthcare providers[5].

Sales Team and Infrastructure

Eagle Pharmaceuticals has emphasized the importance of its sales team in driving the commercial success of Barhemsys. As of 2023, the sales team is fully sized and fully trained, which is expected to further boost sales objectives for the product. The company's existing relationships with healthcare providers and its experienced hospital-based salesforce are key factors in realizing the full potential of Barhemsys[1][3][4].

Financial Impact

The acquisition of Acacia Pharma and the inclusion of Barhemsys in Eagle Pharmaceuticals' portfolio are expected to be earnings accretive in 2024. The financial performance of Barhemsys contributes to the overall revenue and profitability of Eagle Pharmaceuticals. For instance, the total revenue for the second quarter of 2023 was $64.6 million, with product sales netting $42.993 million, which includes contributions from Barhemsys[2][5].

Competitive Landscape

While Barhemsys holds a unique position in the market due to its FDA-approved indication, the broader antiemetic market is competitive. However, Eagle Pharmaceuticals' strong commercial infrastructure and the differentiated nature of Barhemsys are expected to help maintain its market share. The company's focus on leveraging its salesforce and existing relationships to promote Barhemsys is crucial in this competitive environment[4].

Future Outlook

Eagle Pharmaceuticals is optimistic about the future performance of Barhemsys. With the sales momentum continuing to build and the company's plans to leverage its commercial infrastructure, there is a strong expectation that Barhemsys will continue to grow in sales and contribute significantly to the company's revenue. The company has raised its full-year 2023 guidance, reflecting confidence in the ongoing growth of its marketed drugs, including Barhemsys[5].

Key Takeaways

• Unique Market Position: Barhemsys is the first and only FDA-approved antiemetic for PONV rescue after failed prophylaxis.
• Growing Sales: Combined sales of Barhemsys and Byfavo showed significant growth in 2022 and 2023.
• Strong Sales Team: Eagle Pharmaceuticals' fully trained and sized sales team is crucial for driving sales.
• Financial Contribution: Barhemsys is expected to be earnings accretive in 2024 and contributes to the company's overall revenue.
• Competitive Advantage: The product's unique FDA approval and the company's commercial infrastructure help maintain its market share.

FAQs

Q: What is the unique FDA-approved indication for Barhemsys? A: Barhemsys is the first and only FDA-approved antiemetic for the rescue treatment of postoperative nausea and vomiting (PONV) despite prophylaxis[3][4][5].

Q: How have the sales of Barhemsys performed since its acquisition by Eagle Pharmaceuticals? A: The combined sales of Barhemsys and Byfavo doubled in the second half of 2022 compared to the same period in 2021 and showed 30% sequential growth in the second quarter of 2023[1][2][5].

Q: What is the estimated annual U.S. addressable market for Barhemsys? A: The total estimated annual U.S. addressable market for PONV prophylaxis and rescue is $2.7 billion[4].

Q: How many patients and healthcare facilities have adopted Barhemsys as of the second quarter of 2023? A: An estimated 19,000 patients were dosed with Barhemsys or Byfavo, and 275 healthcare facilities purchased the products out of a total targeted market of approximately 4,000 facilities[5].

Q: What is the expected financial impact of Barhemsys on Eagle Pharmaceuticals? A: The acquisition of Barhemsys is expected to be earnings accretive in 2024, contributing to the company's overall revenue and profitability[2][5].

Sources

1. Annual Report - Eagle Pharmaceuticals, Inc.
2. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - citybiz
3. Annual Report 2022 - Eagle Pharmaceuticals, Inc.
4. Eagle Pharmaceuticals Completes Acquisition of Acacia Pharma Group - Eagle Pharmaceuticals
5. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Eagle Pharmaceuticals