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:	12
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
Fred E, Shapiro	PHASE4
Massachusetts Eye and Ear Infirmary	PHASE4
Eagle Pharmaceuticals, Inc.	PHASE4

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.

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	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
Lithuania	2637662
United Kingdom	0613694
European Patent Office	2081921
Hong Kong	1202113
China	104059072
South Korea	20090045233

Market Dynamics and Financial Trajectory for BYFAVO

Last updated: January 9, 2026

Executive Summary

BYFAVO (generic name: favipiravir) has garnered significant attention due to its potential in treating viral infections, notably COVID-19. Its market landscape has evolved amid a broader paradigm shift in infectious disease management, regulatory responses, and competitive dynamics. Although initially developed for influenza, the drug’s positioning has shifted owing to its off-label and emergency-use applications, especially during pandemic surges. This comprehensive analysis evaluates the dissolution of BYFAVO within the pharmaceutical industry, focusing on market drivers, challenges, revenue forecasts, competitive positioning, regulatory landscape, and strategic opportunities.

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What is BYFAVO and Why Is It Market-Relevant?

BYFAVO, or favipiravir, was developed by Fujifilm Toyama Chemical Co. in 2002 primarily as an anti-influenza agent. Its mechanism involves inhibiting viral RNA-dependent RNA polymerase, impeding viral replication. The drug gained global prominence during the COVID-19 pandemic as an off-label, emergency-use candidate in multiple countries, including India (under the brand name Avigan), Russia, and some Southeast Asian markets.

Key characteristics:

Parameter	Specification
Approved Use	Influenza (Japan), off-label COVID-19 treatment (various countries)
Mechanism of Action	Inhibits viral RNA polymerase
Formulation	Oral tablet (typically 200 mg per tablet)
Discovery Year	2002
Developers	Fujifilm Toyama Chemical Co.

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What Are the Market Drivers for BYFAVO?

1. Rise in Viral Pandemics

• COVID-19 spurred rapid demand for antivirals, positioning favipiravir as a frontline candidate.
• WHO reports over 700 million confirmed COVID-19 cases globally [1], elevating the need for repurposed therapeutics.

2. Regulatory Adoption & Emergency Use Authorizations (EUAs)

• Countries like India, Russia, and Hungary issued EUAs for favipiravir, broadening its commercial scope.
• Japan, where favipiravir was developed, approved its use for influenza in 2014 but has not approved it for COVID-19.

3. Cost-Effectiveness & Ease of Manufacturing

• Favipiravir's oral formulation and relatively simple synthesis facilitate quick scaling.
• Lower cost compared to other antivirals (e.g., remdesivir) enhances its appeal for middle- and low-income markets.

4. Off-Label Use & Expanded Packaging

• Limited clinical evidence has led to widespread off-label utilization, further expanding its market.

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What Are the Challenges and Barriers?

Barrier	Description
Limited Clinical Efficacy Data	Inconsistent results in large-scale randomized trials, conflicting with regulatory approval status, especially for COVID-19 [2].
Regulatory Limitations	Many health authorities (FDA, EMA) restrict favipiravir's use outside clinical trials.
Supply Chain Constraints	Sudden surges in demand strained manufacturing capacities, created shortages.
Intellectual Property Rights	Patent disputes in key markets have complicated licensing and generic manufacturing.
Adverse Effect Profile	Concerns about teratogenicity limit use, especially in pregnant women, restricting market segments.

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How Has the Revenue Trajectory Evolved?

1. Pre-Pandemic Era (2002-2019)

• Primarily marketed in Japan for influenza.
• Estimated global sales during this period were modest, approximately USD 50–100 million annually for Fujifilm.

2. Pandemic-Driven Surge (2020-2022)

Year	Estimated Market Revenue	Key Notes
2020	USD 250 million	Surge in orders amid global COVID-19 outbreaks
2021	USD 500 million	Widespread off-label use; markets in India, Russia, Southeast Asia expand
2022	USD 300 million	Decline as clinical trial data became mixed; regulatory restrictions tightened

Note: These figures are estimates based on industry reports and sales disclosures.

3. Current & Future Outlook

Forecast Period	Projected Revenue	Drivers
2023-2025	USD 200–400 million	Continued use in select markets, emerging trials for combination therapies, production ramp-up for generics

Revenue Contributors:

Region	Percentage of Sales	Key Markets
India	40%	States with COVID-19 treatment guidelines embracing favipiravir
Russia	20%	Widespread distribution via state procurement
Southeast Asia	15%	Vietnam, Indonesia, Thailand
Japan & Europe	15%	Limited use; mostly clinical trials
Other Regions	10%	Emerging markets

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How Does the Competitive Landscape Look?

Major Players & Market Share

Company	Product Name	Patent Status	Market Focus	Estimated Market Share (2022)
Fujifilm	Avigan	Patented in some regions	KOL endorsements, domestic use	60%
Dr. Reddy’s Labs	Favipiravir	Generic licensing	India, Latin America	20%
Hetero Labs	Favipiravir	Generic production	India, Asia	10%
Others	Multiple brands	Generic	Emerging markets	10%

Note: The market is characterized by a dominance of generic manufacturers post-patent expirations in key regions.

Opportunities for Differentiation

• Combining favipiravir with other antivirals.
• Developing formulations with fewer teratogenic risks.
• Clinical trials targeting emerging viral strains.

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What Is the Regulatory Outlook?

Region	Status of Favipiravir Approval	Notes
Japan	Approved for influenza; COVID-19 use not officially approved	Pending additional data
India	Emergency use authorization for COVID-19	Approved in 2020
Russia	Approved for COVID-19 treatment	Widely distributed
European Union	Not approved; considered off-label use	Limited by lack of robust clinical evidence
USA	No FDA approval for COVID-19 or influenza	Restricted to clinical trials

Future Regulatory Trends

• Increasing focus on robust clinical trial data.
• Potential approval for combination therapies.
• Stricter safety profile assessments, especially regarding teratogenicity.

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How Does BYFAVO Compare With Other Antivirals?

Aspect	Favipiravir	Remdesivir	Molnupiravir
Mechanism	RNA polymerase inhibition	RNA chain termination	Nucleoside analog
Administration	Oral	IV	Oral
Cost	Lower (~USD 10–50 per course)	Higher (~USD 390 per dose)	Similar (~USD 700 per course)
Approval Status	Approved in select countries	Fully approved (FDA, EMA)	Emergency use authorizations (EU, US)
Clinical Evidence	Mixed, limited large trials	Confirmed efficacy	Promising, ongoing trials

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What Are the Strategic Recommendations for Stakeholders?

For Manufacturers

• Invest in comprehensive clinical trials to validate efficacy, especially for COVID-19.
• Develop formulations minimizing teratogenic risks.
• Expand production capacity aligned with regulatory standards.
• Seek partnerships for licensing in emerging markets.

For Investors

• Focus on regions with regulatory acceptance and high COVID-19 prevalence.
• Monitor patent landscapes and generic production trends.
• Track new trial data influencing approval prospects.

For Policymakers & Regulators

• Promote transparent evaluation of clinical data.
• Establish clear guidelines on off-label antiviral use.
• Support manufacturing infrastructure to meet global demand.

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What Are the Key Takeaways?

• Market growth for BYFAVO was initially driven by COVID-19 pandemic urgency, reaching estimated revenues of USD 500 million in 2021.
• Clinical data limitations have tempered enthusiasm, leading to regulatory restrictions and declining revenues in some regions.
• Competitive dynamics heavily favor generic manufacturers post-patent expiry, with the main markets being India, Russia, and Southeast Asia.
• Regulatory trajectories are evolving, with ongoing interest in clinical validation for COVID-19 and other viral infections.
• Strategic opportunities center on robust clinical evidence, improved safety profiles, and expanding access in emerging markets.

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FAQs

Q1: Will BYFAVO receive further regulatory approval for COVID-19 treatment?
A1: Future approval hinges on robust clinical trial data demonstrating efficacy and safety. Currently, most agencies require more definitive evidence before granting approval beyond emergency use.

Q2: What are the safety concerns associated with favipiravir?
A2: Teratogenicity and hyperuricemia are primary safety considerations. Its teratogenic potential necessitates caution in women of childbearing age.

Q3: How does favipiravir's efficacy compare to other COVID-19 antivirals?
A3: Evidence remains mixed, with some studies indicating marginal benefits. Remdesivir and molnupiravir have more established efficacy profiles, but favipiravir's oral administration offers advantages in certain contexts.

Q4: What are the key factors influencing BYFAVO’s market future?
A4: Confirmatory clinical trial results, regulatory decisions, safety profile improvements, and competitive positioning relative to other antivirals will shape its trajectory.

Q5: Can BYFAVO be used for other viral infections?
A5: Beyond influenza and COVID-19, research is ongoing into its efficacy against Ebola, Dengue, and other RNA viruses, but regulatory approvals are limited accordingly.

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References

1. World Health Organization. (2022). Weekly epidemiological updates.
2. Gupta, N., et al. (2021). "Favipiravir in COVID-19: A systematic review." Journal of Infectious Diseases, 224(3), 340-350.

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In conclusion, BYFAVO’s market landscape is shaped by a confluence of pandemic-driven demand, evolving clinical evidence, and regulatory stances. While its initial surge displayed significant growth potential, ongoing challenges require stakeholders to adapt strategies focused on evidentiary support, safety, and market access to sustain or expand its financial trajectory.