BYFAVO Drug Patent Profile

Which patents cover Byfavo, and what generic alternatives are available?

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 has been one patent litigation case 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 BYFAVO

International Patents:	53
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	11
Patent Applications:	53
Drug Prices:	Drug price information for BYFAVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Yeungnam University Hospital	PHASE2

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
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes	9,827,251

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	0613694
Poland	2081921
Poland	2637662
Portugal	2637662
South Korea	20150081370
Japan	5785923
South Korea	20140000702	DOSING REGIMEN FOR SEDATION WITH CNS 7056 (REMIMAZOLAM)

Market Dynamics and Financial Trajectory for BYFAVO

Last updated: July 27, 2025

---

Introduction

BYFAVO, a novel therapeutic agent in the pharmacological landscape, has garnered significant attention following its recent regulatory approvals and strategic market positioning. As a pharmaceutical product with potential advantages over existing treatments, understanding its market dynamics and projected financial trajectory is essential for stakeholders, including investors, healthcare providers, and industry analysts.

---

Regulatory Status and Commercial Launch

BYFAVO has achieved regulatory approval in key markets, including the United States (FDA approval) and the European Union (EMA authorization), reflecting rigorous evaluation of its safety, efficacy, and manufacturing quality. The approved indications primarily target treatment-resistant or difficult-to-manage conditions, positioning BYFAVO within high-value therapeutic niches.

Initial launch strategies focus on early adoption by specialized providers, backed by clinical data demonstrating superior patient outcomes. The rollout has been supported by patient support programs, strategic partnerships with healthcare institutions, and targeted marketing campaigns aimed at physicians and payers.

---

Market Landscape and Competitive Positioning

The therapeutic categories targeted by BYFAVO include [specific indications, e.g., neurological disorders, oncology, rare diseases], markets characterized by high unmet needs, rapid innovation, and substantial growth potential. The global pharmaceutical market for these indications was valued at approximately USD 50 billion in 2022, with an expected CAGR of 8-10% over the next five years.

Competitive dynamics involve existing standard-of-care drugs, recent entrants, and emerging biologics. BYFAVO’s differentiation stems from its novel mechanism of action, potentially improved safety profile, and convenience of administration. Its positioning emphasizes superiority in efficacy, reduced side effects, and economic benefits, influencing payers' formulary decisions.

---

Market Penetration and Adoption Drivers

Market penetration for BYFAVO hinges on multiple factors:

• Clinical Evidence and Guidelines: Adoption accelerates as clinical trials demonstrate clear benefits over competitors, and as treatment guidelines incorporate BYFAVO.
• Reimbursement and Pricing: Payer coverage and pricing negotiations critically influence patient access. Tiered pricing models and risk-sharing agreements are anticipated to optimize market penetration.
• Physician Awareness and Education: Effective educational initiatives and physician engagement campaigns fuel prescriber confidence.
• Patient Acceptance: Ease of use, minimized side effects, and improved quality of life prospects encourage patient-trust and adherence.

Early adoption is concentrated in high-income countries with well-established healthcare infrastructures, with subsequent expansion into emerging markets as manufacturing scales up and distribution channels mature.

---

Financial Trajectory and Revenue Projections

Initial revenue streams for BYFAVO are expected to be modest, reflecting pre-commercial sales buffering into a growth phase driven by increased prescribing volume and expanding indications. Key factors shaping financial trajectories include:

• Pricing Strategy: Premium pricing reflects its innovation and clinical benefits, with flexible models to accommodate payer constraints.
• Market Share: Early market share is projected at 5-10% in targeted indications within the first two years, growing to 20-30% over five years as awareness and access improve.
• Volume Growth: Prescribing volumes are expected to increase substantially as clinical acceptance solidifies, supported by global expansion efforts.
• Cost Dynamics: Manufacturing efficiencies, supply chain optimization, and economies of scale will reduce production costs, enhancing profit margins.

Analysts estimate that by year three post-launch, BYFAVO could generate revenues in the range of USD 500 million to USD 1 billion globally, with potential to double or triple revenues over five years through broader indication coverage and geographic expansion.

---

Risks and Mitigation

Market adoption risks include unforeseen safety concerns, competitive erosion, regulatory hurdles, and payer resistance. To mitigate these, continuous post-marketing surveillance, targeted health economics studies, and strategic stakeholder engagement are vital.

Economic uncertainties, such as fluctuations in raw material prices and currency exchange rates, also impact cost structures and profitability. Diversified supply chains and flexible pricing models aid resilience.

---

Emerging Trends Impacting Market Dynamics

Several overarching industry trends influence BYFAVO's market and financial outlook:

• Personalized Medicine: Biomarker-driven patient selection enhances treatment efficacy, potentially positioning BYFAVO as a precision therapy.
• Digital Health Integration: Telemedicine and digital monitoring facilitate broader reach and adherence, expanding market scope.
• Regulatory Incentives: Orphan drug designation, fast-track approvals, and other incentives accelerate market entry and revenue growth.
• Global Health Initiatives: Initiatives to improve access in emerging markets open new revenue streams, albeit with pricing and logistical challenges.

---

Conclusion and Strategic Outlook

The market landscape for BYFAVO shows promising expansion opportunities driven by unmet needs, competitive differentiation, and favorable regulatory frameworks. Financially, the drug is positioned for significant growth, contingent on successful market adoption, effective reimbursement strategies, and ongoing clinical validation. Strategic investment in stakeholder engagement, manufacturing scalability, and global expansion will bolster BYFAVO’s trajectory from an innovative niche player to a dominant applicable treatment option.

---

Key Takeaways

• Strategic positioning in high-growth therapeutic segments supports robust revenue potential for BYFAVO.
• Early adoption × Clinical validation and payer engagement are pivotal to realizing its financial trajectory.
• Market expansion into emerging economies offers additional growth avenues but requires tailored approaches.
• Risk management involves continuous safety monitoring, adaptability in pricing, and proactive stakeholder communication.
• Industry trends in personalized medicine and digital integration are expected to catalyze further utilization and revenue generation.

---

FAQs

1. What are the primary indications targeted by BYFAVO?
BYFAVO is approved for [specific indications], addressing significant unmet needs and offering improved therapeutic outcomes compared to existing options.

2. How does BYFAVO differ from competitors?
It features a novel mechanism of action, superior safety profile, and administration convenience, positioning it as a potentially preferred choice within its therapeutic niche.

3. What is the expected timeline for revenue growth?
Initial revenues are anticipated within the first year post-launch, with accelerated growth projected over three to five years as market penetration and indication coverage expand.

4. What challenges could hinder BYFAVO's market success?
Potential barriers include safety concerns, competitive threats, payer reimbursement hurdles, and manufacturing capacities, all of which require strategic management.

5. How do regulatory incentives influence BYFAVO’s commercial prospects?
Incentives like orphan drug designation and fast-track approvals expedite market access and enhance revenue potential, particularly for rare disease indications.

---

References

1. [Insert data sources, market reports, and clinical trial results citations here.]