RAPIVAB Drug Patent Profile

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

Rapivab is a drug marketed by Biocryst and is included in one NDA. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the peramivir profile page.

DrugPatentWatch^® Generic Entry Outlook for Rapivab

Rapivab was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 12, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RAPIVAB

International Patents:	43
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	3
Patent Applications:	1,531
Drug Prices:	Drug price information for RAPIVAB
What excipients (inactive ingredients) are in RAPIVAB?	RAPIVAB excipients list
DailyMed Link:	RAPIVAB at DailyMed

See drug prices for RAPIVAB

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

NDA:

206426

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 RAPIVAB

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

Sponsor	Phase
University of Oxford	Phase 2
BioCryst Pharmaceuticals	Phase 3
Department of Health and Human Services	Phase 4

See all RAPIVAB clinical trials

US Patents and Regulatory Information for RAPIVAB

RAPIVAB is protected by five 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
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes

Expired US Patents for RAPIVAB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014

EU/EMA Drug Approvals for RAPIVAB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Biocryst	Alpivab	peramivir	EMEA/H/C/004299Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.	Withdrawn	no	no	no	2018-04-13

International Patents for RAPIVAB

When does loss-of-exclusivity occur for RAPIVAB?

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Malaysia

Mexico

New Zealand

South Africa

South Korea

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 RAPIVAB around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20200143519	정맥내 항바이러스 치료 (INTRAVENOUS ANTIVIRAL TREATMENTS)
South Korea	20140132778	INTRAVENOUS ANTIVIRAL TREATMENTS
Cyprus	1109153
South Korea	102475176
World Intellectual Property Organization (WIPO)	2007117241

Market Dynamics and Financial Trajectory for RAPIVAB (Peramivir)

Last updated: July 28, 2025

Introduction

RAPIVAB (peramivir) emerges as a pivotal antiviral therapy primarily designated for the treatment of influenza. Developed by BioCryst Pharmaceuticals, RAPIVAB received regulatory approval in multiple regions, including the United States (2015), for acute uncomplicated influenza. Its unique intravenous (IV) administration distinguishes it from oral or inhaled antiviral options, impacting its market penetration, competitive positioning, and financial prospects. This analysis examines the key market determinants and financial trajectory associated with RAPIVAB, contextualizing its role within the broader influenza treatment landscape.

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Market Overview: Influenza and Antiviral Pharmacology

Influenza remains a perennial global health challenge, with annual epidemics causing significant morbidity and mortality, especially among high-risk populations. According to the World Health Organization (WHO), seasonal influenza results in approximately 3–5 million severe cases and 290,000–650,000 deaths globally annually [1].

Current antivirals, including oseltamivir (Tamiflu), zanamivir, baloxavir marboxil, and peramivir, form the cornerstone of influenza management. While oral and inhaled formulations dominate, RAPIVAB’s IV route specifically caters to hospitalized or severely ill patients, creating a niche within antiviral therapy.

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Market Dynamics

1. Clinical Use and Patient Segmentation

RAPIVAB’s IV formulation positions it effectively for hospital settings, particularly for patients unable to tolerate oral medications or with severe influenza requiring inpatient care. Its rapid administration makes it an attractive option in emergency departments and intensive care units (ICUs), contributing to its tailored clinical application.

2. Competitive Landscape

The antiviral market is characterized by several key players:

• Oseltamivir (Tamiflu): The most widely prescribed oral antiviral, with extensive marketing and a broad spectrum of indications.
• Zanamivir (Relenza): Inhaled therapy targeting outpatient influenza, less suited for hospitalized patients.
• Baloxavir marboxil (Xofluza): A novel oral agent with significant efficacy advantages, particularly in reducing viral shedding.

RAPIVAB faces limited direct competition, primarily from other hospital-based therapies such as intravenous oseltamivir (rarely approved), and is often used in conjunction with supportive care measures. Its niche status diminishes direct competition but confines its market size primarily to inpatient settings.

3. Regulatory and Reimbursement Environment

Regulatory approvals across key markets bolster RAPIVAB’s commercial potential. In the US, the FDA approved RAPIVAB based on demonstrating comparable efficacy and safety to existing antivirals, with labeling emphasizing its IV administration. Reimbursement largely depends on hospital formularies, insurance coverage, and healthcare policies, affecting patient access and market penetration.

4. Market Penetration and Adoption Drivers

Factors influencing RAPIVAB’s adoption include:

• Hospital protocol integration: Adoption depends on clinicians’ familiarity and comfort with IV antivirals.
• Severity of influenza outbreaks: Surge periods increase demand for inpatient antiviral therapies.
• Physician awareness: Educational initiatives can expand use beyond narrow indications.

5. Supply Chain and Manufacturing

BioCryst maintains control over peramivir manufacturing, with ongoing capacity expansion to meet demand. Global health emergencies or influenza pandemics could temporarily spike demand, affecting supply logistics and pricing strategies.

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Financial Trajectory

1. Revenue Streams and Growth Drivers

RAPIVAB’s revenue primarily originates from hospital procurement, reimbursed via governmental and private insurers. Historically, annual sales have faced moderate growth, influenced by influenza seasonality and the extent of hospital adoption.

Recent financial disclosures indicate steady revenue contributions, although global pandemic threats, such as COVID-19, temporarily overshadow influenza, constraining growth prospects.

2. Impact of Seasonal Trends and Pandemic Preparedness

Influenza exhibits predictable seasonal peaks, generally leading to higher quarterly revenues during winter months in temperate regions. However, the outbreak dynamics can be unpredictable, with pandemic influenza or concurrent respiratory disease outbreaks creating sudden demand surges.

In 2020–2021, pandemic measures like social distancing decreased influenza circulation, adversely affecting RAPIVAB sales [2]. Conversely, heightened influenza activity during specific seasons yields promising revenue opportunities.

3. Developmental and Diversification Strategies

BioCryst’s broader pipeline and strategic partnerships aim to diversify revenue streams. Expanding indications (e.g., avian influenza, antiviral prophylaxis) or transitioning to outpatient formulations could significantly alter the financial trajectory. Ongoing clinical trials assessing RAPIVAB’s efficacy in different populations may open additional market segments.

4. Pricing Dynamics and Cost Considerations

Pricing strategies balance profitability and market competitiveness. The IV formulation’s higher cost relative to oral antivirals restricts widespread outpatient use, confining revenues to inpatient settings. Cost pressures from healthcare systems and insurance negotiations influence pricing and, consequently, profit margins.

5. Challenges in Market Expansion

Key hurdles include:

• Limited outpatient applicability.
• Competition from oral antivirals with wider accessibility.
• Rapid emergence of resistance, although currently minimal for peramivir.
• Cost considerations during influenza off-peak seasons.

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Future Outlook and Market Opportunities

1. Pandemic Preparedness and Stockpiling

Governments maintain antiviral stockpiles to address influenza pandemics. RAPIVAB’s profile makes it a candidate for inclusion in strategic reserve inventories, especially given its IV delivery suitable for hospitalized patients during severe outbreaks.

2. Market Expansion via Label Extensions

Seeking approval for additional indications, such as compassionate use in pediatric populations, immunocompromised patients, or off-label influenza strains, can enhance market size.

3. Strategic Partnerships and Market Penetration

Collaborations with healthcare providers and government agencies could facilitate broader inclusion in hospital formularies. Educating clinicians on the benefits of IV antivirals may accelerate uptake, especially amid rising antiviral resistance concerns.

4. Impact of Next-Generation antivirals

The evolving landscape presents both risks and opportunities. The advent of orally administered long-acting antivirals and combination therapies could challenge RAPIVAB’s niche. Conversely, innovations in delivery mechanisms and combination regimens can expand its utility.

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Key Takeaways

• Targeted niche: RAPIVAB’s intravenous formulation limits its use to inpatient influenza cases, primarily affecting its total addressable market.
• Market resilience: Seasonal influenza peaks drive predictable revenue cycles, but overall sales remain sensitive to annual influenza activity levels and pandemic events.
• Competitive positioning: Its primary advantage lies in hospital settings, where limited alternatives exist; however, competition from oral agents and emerging therapies constrains upside potential.
• Growth pathways: Expanding indications, enhancing hospital adoption, and participating in pandemic preparedness efforts can bolster financial trajectory.
• Challenges: Price pressures, resistance development, and shifting treatment protocols necessitate strategic agility.

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Conclusion

RAPIVAB’s market dynamics hinge on its unique formulation and clinical niche within the influenza treatment landscape. While annual seasonal fluctuations influence revenue, its future growth depends on expanded hospital adoption, strategic positioning in pandemic and stockpiling ecosystems, and development of broader indications. The pharmacoeconomic landscape, together with emerging antiviral innovations, will shape its financial trajectory over the coming years.

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FAQs

1. What is the primary clinical advantage of RAPIVAB?
RAPIVAB offers rapid IV administration of peramivir, making it suitable for hospitalized influenza patients who cannot take oral medications or require immediate antiviral therapy.

2. How does RAPIVAB compare to oral antivirals like oseltamivir?
While oseltamivir is more widely used due to oral administration convenience, RAPIVAB's IV route ensures effective delivery in inpatient settings, especially where rapid intervention is critical.

3. Can RAPIVAB be used for influenza strains resistant to other antivirals?
Currently, resistance to peramivir is rare. Its mechanism of action remains effective against most circulating strains, but ongoing surveillance is essential for resistance management.

4. What impact might future pandemics have on RAPIVAB’s market?
Pandemic influenza outbreaks can significantly increase demand for inpatient antiviral therapies like RAPIVAB, especially if stockpiling policies favor IV formulations.

5. What are the prospects for expanding RAPIVAB’s indications?
Clinical research exploring new populations, such as immunocompromised or pediatric patients, could lead to regulatory approval extensions, expanding its market potential.

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References

[1] World Health Organization. Influenza (Seasonal). [Online] Available at: https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)

[2] CDC. Influenza Surveillance Reports. [Online] Available at: https://www.cdc.gov/flu/weekly/overview.htm