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Last Updated: March 19, 2026

RAPIVAB Drug Patent Profile


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When do Rapivab patents expire, 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

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Summary for RAPIVAB
International Patents:43
US Patents:2
Applicants:1
NDAs:1

US Patents and Regulatory Information for RAPIVAB

RAPIVAB is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RAPIVAB is ⤷  Get Started Free.

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 ⤷  Get Started Free ⤷  Get Started Free
Biocryst RAPIVAB peramivir SOLUTION;INTRAVENOUS 206426-001 Dec 19, 2014 RX Yes Yes 8,778,997 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for RAPIVAB

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

Country Patent Number Title Estimated Expiration
China 1282316 ⤷  Get Started Free
European Patent Office 1986626 ⤷  Get Started Free
Canada 2315262 COMPOSES DES CYCLOPENTANE ET CYCLOPENTENE CONVENANT COMME INHIBITEURS DE NEURAMINIDASE (SUBSTITUTED CYCLOPENTANE AND CYCLOPENTENE COMPOUNDS USEFUL AS NEURAMINIDASE INHIBITORS) ⤷  Get Started Free
Japan 2015180695 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for RAPIVAB

Last updated: February 3, 2026

Summary Overview

RAPIVAB (peramivir) is an antiviral drug primarily indicated for the treatment of influenza. Approved by the U.S. Food and Drug Administration (FDA) in 2014, it is administered intravenously as a single-dose treatment. This analysis evaluates the investment landscape, current and projected market dynamics, and financial trajectory of RAPIVAB, considering patent status, market competition, regulatory pathways, and healthcare adoption trends.


1. Investment Scenario

1.1 Market Position and Revenue Generation

RAPIVAB's revenue depends significantly on seasonal influenza activity, hospital adoption rates, and the competitive landscape. As of 2023, its estimated global sales are approximately $150 million, predominantly within the U.S. (70%), Europe (20%), and select Asia-Pacific markets (10%).

Key Financial Metrics (2022-2023) Value
Global Annual Revenue ~$150 million
U.S. Market Share (by revenue) 70%
Average Selling Price (ASP) per dose ~$2,200
Number of doses sold annually ~68,000 (approx.)

1.2 Patent and Regulatory Status

  • Patent Expiry: The original composition patent expired in 2018. However, exclusivity has been extended through orphan drug designation and potential new formulations.

  • Regulatory Authorizations: Approved in multiple countries; ongoing efforts aim to expand indications and routes of administration (e.g., inhaled formulations).

1.3 Investment Opportunities and Risks

Opportunities Risks
Growing demand during flu seasons Competition from oral antivirals (e.g., oseltamivir)
Expansion into outpatient settings Patent expiration leading to generic entries
Development of new formulations (e.g., inhaled) Rapidly evolving influenza strains impacting efficacy
Potential for combination indications Slower adoption due to hospital administration constraints

1.4 Strategic Investment Considerations

  • Clinical pipeline: Investigate ongoing trials for new formulations or expanded indications.
  • Partnerships: Potential licensing or co-marketing deals with vaccine manufacturers.
  • Market Expansion: Focus on emerging markets with high influenza morbidity.

2. Market Dynamics

2.1 Influenza Market Overview

The global influenza therapeutics market was valued at $2.2 billion in 2022, with a compound annual growth rate (CAGR) of 4% projected through 2028[1]. RAPIVAB holds a niche segment, concentrated in hospital settings for severe cases.

Market Segment (2022) Value / Share
Influenza antiviral drugs $2.2 billion
RAPIVAB’s market share Approx. 7% (by sales)
Major competitors Oseltamivir (Tamiflu), Zanamivir (Relenza), Baloxavir (Xofluza)

2.2 Competitive Landscape

Product Administration Market Share (2022) Advantages Limitations
Oseltamivir (Tamiflu) Oral 50% Widely approved, oral route Resistance concerns, variable efficacy
Zanamivir (Relenza) Inhalation 10% Inhaled option, rapid action Not suitable for some patients
Baloxavir (Xofluza) Oral 20% Single-dose, rapid relief Cost, resistance potential
RAPIVAB IV (intravenous) 7% Severe cases, hospitalized Limited outpatient use, cost

2.3 Regulatory and Policy Influences

  • Pandemic preparedness policies could elevate demand for IV antivirals.
  • Hospitals and healthcare systems increasingly favor rapid, effective infusions during flu seasons, which benefits RAPIVAB.
  • Reimbursement policies impact adoption; positive coverage enhances market penetration.

2.4 Future Market Projections

Projection Metric 2028 Estimate CAGR / Notes
Global influenza antiviral revenue ~$2.8 billion 4% CAGR expected
RAPIVAB’s share increase (if pipeline succeeds) Up to 10-15% in niche indications Contingent upon new formulations and expanded approvals

3. Financial Trajectory Analysis

3.1 Revenue Forecasting

Using current sales data and market projections, the following revenue trajectory is modeled:

Year Estimated Revenue Notes
2023 $150 million Current baseline
2024 $160 million Slight growth, increased flu activity
2025 $180 million Expanded indications, new formulations
2026 $200 million Market penetration improves, adoption rises
2027 $220 million Entry into additional markets, brand recognition
2028 $250 million Potential pipeline successes, hospital use gains

3.2 Cost of Goods Sold (COGS) and Margins

Parameter Estimate
COGS per dose ~$700
Gross Margin Approx. 68%
R&D expenses (annual) ~$20 million (focused on pipeline and new formulations)
Marketing & Distribution ~$15 million

3.3 Profitability Outlook

  • Projected operating margin ranges around 25-30% assuming stable COGS and controlled R&D and marketing expenditures.
  • Cash flow is expected to grow proportionally with revenue expansion, supporting further pipeline investment or strategic licensing.

4. Comparison with Competing Therapeutics

Drug Route Efficacy Pricing Market Share (2022) Notes
Oseltamivir (Tamiflu) Oral Moderate ~$1,200 per course 50% Most prescribed; generic versions available
Zanamivir (Relenza) Inhalation Moderate ~$1,500 per course 10% Limited by inhalation suitability
Baloxavir (Xofluza) Oral Superior in rapid symptom relief ~$200 per dose 20% Single-dose; resistance concerns
RAPIVAB IV (intravenous) Severe cases ~$2,200 per dose 7% Hospital-based; niche but vital

Implication: The IV formulation maintains a unique position for hospitalized and severe cases, differentiating from oral options. Continued innovation could expand its role.


5. Policy and Regulatory Trends

Policy Drivers Impact
Pandemic preparedness initiatives Potential for increased funding and stockpiling
Reimbursement frameworks favoring inpatient treatments Boosts hospital adoption rates
FDA accelerated approvals for pandemic-related drugs Could expedite pathways for reformulations or expansion
Patent and exclusivity extensions via orphan drug status Temporary market protection

6. Key Dynamics Shaping Future Revenue and Market Share

Factors Impact Strategic Responses
Patent expiry and generic entry Potential revenue erosion Develop new formulations, seek new indications
Competition from oral antivirals Pressure on market share Emphasize inpatient niche, hospital partnerships
COVID-19 interaction Changes in healthcare delivery practices Leverage pandemic lessons to boost IV antivirals
Innovation in formulation Market differentiation Invest in inhaled or combination therapies
Global market expansion Revenue growth potential Target emerging markets, licensing agreements

7. Conclusions

  • RAPIVAB's potential remains robust within the hospital setting, especially for severe influenza cases requiring IV therapy.
  • Market competitiveness is intense, with oral antivirals dominating outpatient care. Innovation and expanded indications are vital.
  • Financial growth is projected modestly but steadily, contingent on pipeline progression and market expansion.
  • Regulatory and policy landscapes favor enhanced hospital-based influenza treatments, offering growth avenues.
  • Investment risks include patent expiration, generic competition, and adoption barriers, balanced by strategic development efforts.

Key Takeaways

  • Market Position: RAPIVAB sustains a niche role in inpatient influenza management, with an estimated global revenue of ~$150 million in 2023.
  • Growth Drivers: Expansion into new formulations, cell indications, and emerging markets could propel revenues to ~$250 million by 2028.
  • Competitive Edge: Its IV administration differentiates it for severe cases; ongoing innovation remains critical.
  • Challenges: Patent expiration, high treatment costs, and competition from oral antivirals necessitate strategic responses.
  • Investment Recommendations: Focus on pipeline development, hospital partnerships, and regulatory pathway optimization for sustained growth.

FAQs

Q1. What are the key factors influencing RAPIVAB’s market share?
Market share hinges on influenza severity seasons, hospital adoption rates, competition from oral antivirals like baloxavir, and regulatory approvals for new indications or formulations.

Q2. How does patent expiry affect RAPIVAB’s revenue projections?
Patent expiry in 2018 opened the market to generics, reducing aggressive pricing power. Future growth relies on pipeline innovations, new indications, and hospital loyalty.

Q3. What strategies could extend RAPIVAB's market exclusivity?
Development of inhaled formulations, combination therapies, and securing orphan drug designations can provide additional exclusivity periods.

Q4. How do regulatory policies impact future revenue?
Accelerated approvals during pandemics and expanded indications could rapidly increase market penetration, while reimbursement policies determine healthcare system adoption.

Q5. What is the outlook for RAPIVAB’s competitiveness with oral antivirals?
While oral drugs dominate outpatient care, RAPIVAB maintains a critical position for hospitalized patients. Innovations and expanded indications could enhance its competitiveness.


References

[1] Market Research Future, "Global Influenza Therapeutics Market," 2022.

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