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BYFAVO Drug Patent Profile

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

Byfavo is a drug marketed by Acacia and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in twenty-four countries.

The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this compound. Additional details are available on the remimazolam besylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Byfavo

Byfavo was eligible for patent challenges on October 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2027. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BYFAVO

International Patents:	53
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	8
Patent Applications:	32
Drug Prices:	Drug price information for BYFAVO
What excipients (inactive ingredients) are in BYFAVO?	BYFAVO excipients list
DailyMed Link:	BYFAVO at DailyMed

See drug prices for BYFAVO

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

Constraining patent/regulatory exclusivity:

9,777,007

NDA:

212295

Dosage:

POWDER;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 BYFAVO

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
University of California, Los Angeles	Phase 4
Seoul National University Hospital	Phase 2

See all BYFAVO clinical trials

Paragraph IV (Patent) Challenges for BYFAVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYFAVO	Powder for Injection	remimazolam besylate	20 mg/vial	212295	1	2024-10-07

US Patents and Regulatory Information for BYFAVO

BYFAVO is protected by eleven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,777,007.

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	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	10,961,250		Y
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	10,342,800
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	9,737,547
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	9,561,236
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	10,472,365

International Patents for BYFAVO

When does loss-of-exclusivity occur for BYFAVO?

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

Australia

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Poland

Portugal

Russian Federation

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 BYFAVO around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	0613692
Denmark	2081921
Slovenia	2081921
Poland	2081921
United Kingdom	0613694
Serbia	58577

BYFAVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Byfavo

Introduction

Byfavo, a drug developed by Eagle Pharmaceuticals, is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Here, we will delve into the market dynamics and financial trajectory of Byfavo, highlighting its performance, market share, and future growth prospects.

Product Overview

Byfavo is a remimazolam besylate injection, approved by the U.S. Food and Drug Administration (FDA) for procedural sedation. It is part of Eagle Pharmaceuticals' robust portfolio of hospital and oncology products, alongside other successful drugs like Barhemsys and PEMFEXY[1][3].

Market Performance

In the second quarter of 2023, Byfavo demonstrated strong market performance. Here are some key metrics:

• Sales Growth: Combined sales of Byfavo and Barhemsys were $1.2 million, representing approximately 30% sequential growth over the last two quarters. This indicates a robust uptake of the drug in the market[3][5].
• Patient and Facility Adoption: An estimated 19,000 patients were dosed with Byfavo or Barhemsys during the second quarter of 2023, with 275 healthcare facilities purchasing the products out of a total targeted market of approximately 4,000 facilities[3].

Market Share and Competition

Byfavo operates in a competitive procedural sedation market, but it has managed to carve out a significant niche:

• Market Uptake: The positive feedback from physicians and nurses has been a key driver of Byfavo's market uptake. Eagle Pharmaceuticals expects this momentum to continue, driven by the drug's efficacy and the company's strong sales force[1][3].

Financial Trajectory

The financial performance of Byfavo is closely tied to Eagle Pharmaceuticals' overall financial health:

• Revenue Contribution: While the specific revenue contribution of Byfavo alone is not detailed, the combined sales of Byfavo and Barhemsys were significant, contributing to Eagle's total revenue of $64.6 million in the second quarter of 2023[5].
• Adjusted Non-GAAP Metrics: The company reported an adjusted non-GAAP net income of $15.5 million and adjusted non-GAAP EBITDA of $20.7 million for the second quarter of 2023, reflecting the overall financial strength driven by its product portfolio, including Byfavo[5].

Full-Year Guidance and Future Outlook

Eagle Pharmaceuticals has reiterated its positive full-year guidance for 2023, which includes Byfavo's performance:

• Raised Guidance: The company raised its full-year 2023 guidance for adjusted non-GAAP EBITDA to $78.0-$84.0 million and adjusted non-GAAP earnings per share to $4.40-$4.70. This reflects the confidence in the continued growth of its marketed drugs, including Byfavo[3][5].
• Future Growth Opportunities: Eagle plans to leverage its commercial infrastructure and working capital to add complementary products, either through R&D or acquisition, which could further enhance Byfavo's market position and growth potential[3].

Pipeline Progress and R&D

While Byfavo itself is not in the development stage, Eagle Pharmaceuticals' overall R&D efforts and pipeline progress are crucial for its future growth:

• EA-114 Product Candidate: Although not directly related to Byfavo, Eagle's positive results from its EA-114 study (an improved version of Faslodex for HR+/HER- advanced breast cancer) indicate a strong R&D pipeline. This could indirectly benefit Byfavo by enhancing the company's overall market presence and financial stability[1].

Gross Margin and Profitability

The gross margin and profitability of Byfavo, as part of Eagle's product portfolio, have shown significant improvements:

• Gross Margin: The gross margin for the first half of 2023 was 74%, up from 73% in the first half of 2022. The adjusted non-GAAP gross margin was 83%, up from 74% in the prior year period, indicating improved profitability[5].

Conclusion on Market Dynamics

Byfavo's market dynamics are characterized by strong sales growth, increasing market uptake, and positive financial performance. The drug's success is a testament to Eagle Pharmaceuticals' effective sales strategy and the drug's clinical value.

Key Takeaways

• Strong Sales Growth: Byfavo and Barhemsys combined sales showed a 30% sequential growth.
• Market Uptake: Positive feedback from healthcare professionals and significant patient and facility adoption.
• Financial Performance: Contributed to Eagle's total revenue and adjusted non-GAAP metrics.
• Future Outlook: Positive full-year guidance and potential for further growth through R&D and acquisitions.
• Gross Margin: Improved profitability reflected in the company's gross margin and adjusted non-GAAP gross margin.

FAQs

Q: What is Byfavo used for? Byfavo is used for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Q: How has Byfavo performed in terms of sales? Byfavo, combined with Barhemsys, showed $1.2 million in sales in the second quarter of 2023, representing a 30% sequential growth over the last two quarters.

Q: What is the market share of Byfavo? While specific market share figures for Byfavo alone are not provided, the drug has seen significant uptake with 19,000 patients dosed and 275 healthcare facilities purchasing the product.

Q: How does Byfavo contribute to Eagle Pharmaceuticals' financials? Byfavo contributes to Eagle's total revenue and adjusted non-GAAP metrics, with the company reporting a strong financial performance driven by its product portfolio.

Q: What are the future growth prospects for Byfavo? Eagle Pharmaceuticals expects continued growth for Byfavo, driven by positive feedback from healthcare professionals and the company's plans to leverage its commercial infrastructure and working capital to add complementary products.

Sources

1. Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance - Biospace
2. TTY Biopharm 2023 Annual Report - TTY Biopharm
3. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Biospace
4. Net Present Value Model: Byfavo - GlobalData
5. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Eagle Pharmaceuticals Investor Relations