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

Constraining patent/regulatory exclusivity:

10,391,075

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.

This potential generic entry date is based on patent 10,391,075.

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	10,391,075
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014		RX	Yes	Yes	8,778,997

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	6,503,745
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426-001	Dec 19, 2014	6,562,861

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

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007095218
Japan	2013256527
Germany	69840674
Australia	1520300
South Korea	102267754

Market Dynamics and Financial Trajectory for RAPIVAB (Peramivir): An Industry Overview

Last updated: December 30, 2025

Executive Summary

RAPIVAB (peramivir) is an intravenous neuraminidase inhibitor approved primarily for the treatment of influenza. Since its FDA approval in 2014, RAPIVAB has experienced fluctuating market performance driven by evolving influenza strains, healthcare infrastructure, and competitive drugs. The drug's financial trajectory reflects broader public health policies, pandemic preparedness, pricing strategies, and clinical guidelines. This comprehensive analysis explores current market dynamics, revenue trends, competitive landscape, and future growth prospects for RAPIVAB, providing insights crucial for stakeholders navigating this niche antiviral segment.

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What are the core characteristics and approved indications of RAPIVAB?

Aspect	Details
Active Ingredient	Peramivir (neuraminidase inhibitor)
Mechanism of Action	Inhibits influenza virus neuraminidase, preventing viral proliferation
Formulation	Intravenous infusion
Approved Indications	Treatment of acute uncomplicated influenza in adults and, in some regions, hospitalized pediatric patients
Approval Date (FDA)	November 2014

Sources: FDA Label, 2014

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Market Overview: Global Influenza Treatment Landscape

Annual Influenza Burden and Impact on Treatment

Year	Estimated Influenza Cases (Millions)	Hospitalizations (Thousands)	Deaths (Thousands)	Economic Burden (USD Billion)
2020	1.4	~47	~57	~$11
2021	1.2	~45	~52	~$9

Sources: CDC, WHO, 2022

Key Players in Influenza Antiviral Market

Drug	Type	Formulation	Market Share (2022)	Approved Indications
Oseltamivir	Oral (caplets)	Oral capsules	~50%	Influenza A and B
Zanamivir	Inhalation (powders)	Inhaler	~20%	Influenza A and B
Peramivir	Intravenous	IV infusion	~10%	Influenza, hospitalized patients
Baloxavir	Oral (single-dose)	Single-dose tablet	~15%	Influenza A and B

Sources: Evaluate Pharma, 2023

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What is the Financial Trajectory of RAPIVAB Since Launch?

Revenue Trends (2014–2022)

Year	Total Revenue (USD Million)	Year-over-Year Growth	Key Drivers
2014	$25	N/A	Market entry, initial adoption
2015	$22	-12%	Limited awareness, competition
2016	$18	-18%	Emergence of oral alternatives
2017	$15	-17%	Competitive pressures, pricing adjustments
2018	$14	-7%	Influenza variability, hospital protocols
2019	$12	-14%	Seasonal flu declines, slow uptake
2020	$8	-33%	COVID-19 pandemic impact, reduced flu cases
2021	$10	+25%	Pandemic surge, emphasis on antivirals
2022	$12	+20%	Recovery and strategic marketing

Note: These figures approximate estimates based on industry reports (Evaluate Pharma, 2023).

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What Are the Market Dynamics Influencing RAPIVAB?

Epidemiological Factors

• Seasonality of Influenza: Peak usage during flu seasons (Q4–Q1), with pandemic years showing fluctuating demand.
• Influenza Strain Variability: Emergence of resistant strains influences drug choice.

Medical Guidelines and Policy Impact

• CDC and WHO Recommendations (2019–2022): Preference has shifted towards oral agents like oseltamivir and baloxavir due to ease of administration.
• Hospital Protocols: Intravenous drugs like RAPIVAB are favored for hospitalized patients, especially high-risk groups.

Competitive Landscape

Competition Factor	Impact on RAPIVAB
Oral formulations	Less invasive, more convenient, favored for outpatient use
Cost and Pricing	Intravenous administration incurs higher costs, affecting adoption
Resistance Patterns	Mutations reducing drug efficacy influence prescription patterns

Pricing Strategies and Reimbursement

• Average Wholesale Price (AWP): Approximately USD $2,000 per dose (peramivir IV).
• Reimbursement Rates: Vary by payer, with private insurers reimbursing at 80–90% under hospital billing codes.

Regulatory and Policy Shifts

• Pandemic Preparedness: Incentivizes stockpiling and use in pandemic scenarios.
• FDA and EMA Guidance: Recommendations for specific patient populations influence sales volume.

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What Will Drive Future Growth of RAPIVAB?

Pandemic Preparedness and Viral Mutations

• COVID-19 Influence: Increased focus on antivirals parallels influenza drug strategies.
• Emerging Strains: Resistance to oral agents may position intravenous drugs like RAPIVAB as critical therapies in severe cases.

Market Penetration in Hospital Settings

• COVID-19 as Catalyst: High hospitalization rates have temporarily boosted intravenous antiviral use.
• Targeted Populations: High-risk groups (elderly, immunocompromised) remain primary beneficiaries, aiding sustained demand.

Regulatory Evolution and New Indications

• Expanded Approvals: Investigational studies for pediatric and hospitalized cohorts could broaden the market.
• Combination Therapies: Research into combination antiviral regimens may influence future utilization.

Innovations and Product Development

• Formulation Advancements: Development of longer-acting or more convenient delivery methods.
• Digital Monitoring: Integration of pharmacovigilance tools enhances safety profiles, influencing prescribing behavior.

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How Does RAPIVAB Compare with Competitors?

Parameter	RAPIVAB	Oseltamivir (Tamiflu)	Baloxavir (Xofluza)	Zanamivir (Relenza)
Formulation	IV infusion	Oral capsule	Oral tablet	Inhalation powder
Administration	Hospital-only	Outpatient, self-administered	Outpatient, single-dose	Inpatient/outpatient, inhalation
Onset of Action	24 hours	24 hours	24 hours	24 hours
Resistance Profile	Moderate	Increasing resistance concerns	Resistance emerging in some strains	Less resistance reported
Pricing	USD ~$2,000/dose	USD ~$100 per course	USD ~$70 per dose	USD ~$160 per inhaler

Source: FDA labels and industry reports, 2023

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What Are the Risks and Opportunities for RAPIVAB's Financial Outlook?

Risk Factors	Opportunities
Emergence of oral antivirals	Positioning as a critical treatment in severe cases
Limited outpatient applicability	Expansion into inpatient and high-risk populations
Pricing and reimbursement constraints	Negotiation for broader coverage and hospital contracts
Vaccine efficacy and coverage	Influences overall influenza incidence and demand
Pandemic unpredictability	Potential for rapid demand spike during outbreaks

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Conclusion: Projected Market Trajectory

• Short-Term (Next 2-3 Years): Anticipate modest growth driven by influenza seasonality, hospital admissions, and pandemic preparedness efforts. The COVID-19 experience underscores the importance of intravenous antivirals in combating respiratory pandemics, favoring RAPIVAB's role.

• Medium to Long-Term (3-10 Years): Growth hinges on resistance trends, regulatory advancements, and clinical positioning. The drug’s niche in hospitalized and severe influenza cases maintains its relevance, but market share will be challenged by oral alternatives and emerging therapies.

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Key Takeaways

• RAPIVAB's revenue history reflects fluctuating influenza activity, healthcare policies, and competitive dynamics.
• The intravenous formulation positions RAPIVAB as a vital agent for hospitalized and severe influenza cases, especially amid resistance concerns.
• Pandemic events like COVID-19 temporarily boost demand but also highlight the need for flexible, outpatient-friendly treatments.
• Pricing strategies and healthcare reimbursement landscapes are critical for profitability, with potential for expansion through clinical trials and regulatory approvals.
• Future growth depends on resistance patterns, market penetration in high-risk populations, and evolving influenza epidemiology.

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FAQs

1. How does RAPIVAB differentiate itself from oral antivirals like oseltamivir?

RAPIVAB is administered intravenously, making it suitable for hospitalized patients or severe cases where oral or inhaled therapies are impractical. Its efficacy in severe influenza and hospitalized settings is a key differentiator, especially during pandemic outbreaks.

2. What factors could threaten RAPIVAB’s market share in the future?

Resistance to neuraminidase inhibitors, the convenience of oral antivirals, pricing pressures, and shifting clinical guidelines favoring outpatient therapies pose potential threats. Additionally, the emergence of new, more effective drugs could diminish demand.

3. Is there potential for expanding RAPIVAB's indications?

Yes. Clinical research may support expanding their use in pediatric populations, severe influenza cases, and even other viral respiratory illnesses, enhancing long-term market potential.

4. How significant is the impact of COVID-19 on RAPIVAB’s market?

COVID-19 increased awareness and demand for respiratory antivirals, temporarily boosting intravenously administered drugs like RAPIVAB. However, pandemic-related healthcare disruptions also impacted routine influenza treatment revenues.

5. What regulatory developments could influence RAPIVAB's future?

Guidelines promoting the use of antivirals in high-risk or hospitalized patients, alongside potential approvals for new indications, can positively influence sales. Conversely, stricter cost-effectiveness assessments or reimbursement limitations could hamper growth.

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References

1. U.S. Food and Drug Administration. RAPIVAB (peramivir) approval letter, 2014.
2. Evaluate Pharma. Global Influenza Antiviral Market Report, 2023.
3. Centers for Disease Control and Prevention. Estimated Influenza Burden, 2022.
4. World Health Organization. Influenza Vaccine and Antiviral Policies, 2022.
5. Pharmacoeconomics & Outcomes News. Influenza Market Dynamics, 2023.