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:	142
Clinical Trials:	3
Patent Applications:	1,510
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/004299 Alpivab 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
Spain	2324746
Portugal	1040094
European Patent Office	1986626	TRAITEMENTS ANTIVIRAUX INTRAVEINEUX (INTRAVENOUS ANTIVIRAL TREATMENTS)
South Korea	20080096829	INTRAVENOUS ANTIVIRAL TREATMENTS

Market Dynamics and Financial Trajectory for RAPIVAB

Last updated: July 3, 2025

Introduction

In the fast-paced world of pharmaceuticals, understanding the market forces and financial paths of key drugs like RAPIVAB can empower business leaders to navigate risks and seize opportunities. RAPIVAB, the brand name for peramivir, serves as a critical antiviral treatment for acute uncomplicated influenza, offering rapid intravenous administration during flu outbreaks. Developed by BioCryst Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in 2014, this drug has carved a niche in a competitive landscape shaped by seasonal demand, regulatory hurdles, and evolving healthcare policies. As global influenza cases persist, analyzing RAPIVAB's market dynamics and financial trajectory provides actionable insights for investors, executives, and analysts alike.

Overview of RAPIVAB

RAPIVAB stands out as an neuraminidase inhibitor, a class of drugs that block the enzyme responsible for viral replication in influenza A and B viruses. Unlike oral alternatives such as oseltamivir (Tamiflu), RAPIVAB delivers its effects through a single intravenous dose, making it ideal for hospitalized patients or those unable to take oral medications. The FDA granted it emergency use authorization during the 2009 H1N1 pandemic, leading to full approval for adults in 2014 and expanded use for pediatric patients in 2018.

BioCryst Pharmaceuticals has positioned RAPIVAB as a strategic asset, leveraging partnerships with governments and health organizations for stockpiling during flu seasons. However, its market presence hinges on factors like patent protection, which expires in the U.S. in 2024, potentially opening the door to generics. This overview underscores RAPIVAB's role not just as a treatment, but as a barometer for the broader antiviral market, where innovation and accessibility drive commercial success.

Current Market Dynamics

The influenza treatment market, valued at approximately $5.5 billion globally in 2023, experiences significant fluctuations driven by seasonal epidemics and pandemics. RAPIVAB captures a modest share, estimated at 2-3%, due to its specialized intravenous delivery and targeted patient population. Demand peaks during winter months in the Northern Hemisphere, with U.S. sales often surging by 40-50% in Q4, as evidenced by BioCryst's quarterly reports.

Competition intensifies this dynamic. RAPIVAB faces established rivals like Roche's Tamiflu and GlaxoSmithKline's Relenza, which dominate with broader oral formulations and larger market penetration. In 2023, Tamiflu alone generated over $1 billion in revenue, highlighting the challenge for niche players like RAPIVAB. Regulatory environments further shape the landscape: The FDA and European Medicines Agency (EMA) impose strict post-marketing surveillance, including adverse event reporting, which can delay expansions or approvals in new regions.

Patent dynamics add another layer of complexity. BioCryst's core patent for peramivir expires in 2024 in the U.S., potentially eroding pricing power as generics enter. However, the company has pursued secondary patents for combination therapies and pediatric formulations, extending protection in select markets. Global supply chain disruptions, exacerbated by the COVID-19 pandemic, have also impacted RAPIVAB's availability, with shortages reported in Asia-Pacific regions in 2022. These factors create a volatile environment where strategic alliances, such as BioCryst's agreements with BARDA (Biomedical Advanced Research and Development Authority), become essential for maintaining market share.

Emerging trends, like the rise of telemedicine and at-home testing, could indirectly boost RAPIVAB by increasing early influenza diagnoses. Yet, economic pressures, including inflation and healthcare budget cuts, may suppress demand in developing markets. Analysts from IQVIA note that antiviral sales could grow at a compound annual growth rate (CAGR) of 4-6% through 2028, with RAPIVAB benefiting from niche growth in hospital settings.

Financial Performance and Trajectory

BioCryst Pharmaceuticals' financial story with RAPIVAB reflects both resilience and vulnerability. Since its launch, RAPIVAB has contributed significantly to the company's revenue, peaking at $28 million in 2020 amid heightened flu activity and pandemic preparedness. In 2023, sales dipped to $18 million, a 35% decline from the prior year, attributed to milder flu seasons and generic threats in international markets. This trajectory underscores the drug's sensitivity to external factors like viral mutation rates and public health funding.

Overall, BioCryst reported $291 million in total revenue for 2023, with RAPIVAB accounting for about 6% of that figure. Gross margins for the drug hover around 75%, driven by efficient manufacturing partnerships, but net profitability remains challenged by high R&D costs—totaling $150 million in 2023—for pipeline expansions. Stock performance has been erratic: BioCryst's shares rose 25% in 2021 on RAPIVAB stockpiling deals but fell 15% in 2023 due to patent expiration concerns.

Looking ahead, financial projections hinge on diversification. BioCryst is exploring RAPIVAB's potential in combination therapies for severe respiratory illnesses, which could add $50-100 million in annual revenue by 2026 if trials succeed. Partnerships, such as the $50 million BARDA contract in 2022 for antiviral stockpiles, provide a buffer against market volatility. However, analysts from Bloomberg Intelligence forecast a 10-15% revenue decline for RAPIVAB post-2024 unless new indications emerge, emphasizing the need for cost controls and strategic acquisitions.

Cash flow remains positive, with BioCryst ending 2023 with $300 million in reserves, enabling investments in next-generation antivirals. This financial trajectory illustrates a classic pharmaceutical narrative: high initial returns from innovation, followed by the imperative to innovate further to counter commoditization.

Future Outlook

The path forward for RAPIVAB involves navigating uncertainties in a post-pandemic world. With influenza variants evolving, BioCryst is investing in clinical trials to expand RAPIVAB's label to include high-risk groups, such as immunocompromised patients. If successful, this could propel market growth, potentially increasing annual sales by 20-30% in the U.S. alone.

Global expansion offers another avenue. While RAPIVAB is approved in over 50 countries, penetration in emerging markets like India and Brazil remains low due to pricing and infrastructure barriers. BioCryst's recent licensing deals with local distributors aim to address this, targeting a 15% market share increase in Asia by 2025. However, climate-driven changes in flu patterns, such as year-round outbreaks in tropical regions, could create new demand pockets.

On the flip side, risks abound. Generic competition post-2024 may slash prices by 50-70%, eroding margins unless BioCryst differentiates through premium formulations. Regulatory shifts, including potential FDA reforms on antiviral approvals, could accelerate or hinder progress. Industry experts predict that advancements in mRNA-based flu vaccines might reduce the need for treatments like RAPIVAB, posing a long-term threat.

Despite these challenges, opportunities in public health emergencies remain. Governments worldwide are bolstering antiviral stockpiles, as seen in the WHO's 2023 influenza preparedness plan, which could sustain RAPIVAB's relevance. For business professionals, this outlook signals the importance of monitoring geopolitical factors, such as trade policies, that influence pharmaceutical supply chains.

Conclusion

RAPIVAB's market dynamics and financial trajectory encapsulate the intricacies of the pharmaceutical sector, where innovation meets economic reality. From seasonal demand surges to patent expirations, the drug's journey offers critical lessons for stakeholders aiming to thrive in volatile markets. As BioCryst adapts to emerging challenges, its ability to pivot will determine RAPIVAB's sustained impact on global health and profitability.

Key Takeaways

• RAPIVAB's revenue is highly seasonal, with potential declines post-2024 due to patent expiration, but strategic partnerships could mitigate risks.
• Competition from established drugs like Tamiflu limits market share, yet niche applications in hospitals provide growth opportunities.
• BioCryst's financial health depends on diversification, with projected revenue from new indications possibly offsetting generic threats.
• Global flu patterns and regulatory environments will shape demand, emphasizing the need for adaptive business strategies.
• Investors should watch for clinical trial outcomes and international expansions as key drivers of future performance.

FAQs

1. What is RAPIVAB and how does it differ from other influenza treatments?
   RAPIVAB is an intravenous antiviral drug that treats acute influenza with a single dose, unlike oral options like Tamiflu, which require multiple doses and may have varying efficacy in severe cases.

2. How has the COVID-19 pandemic affected RAPIVAB's market?
   The pandemic initially boosted RAPIVAB sales through stockpiling, but it later reduced flu cases due to social distancing, leading to a sales dip in 2021-2023.

3. What financial risks does BioCryst face with RAPIVAB?
   Primary risks include patent expiration in 2024, which could introduce generics and cut revenues by up to 50%, alongside R&D costs that strain profitability.

4. Can RAPIVAB be used for new influenza variants?
   RAPIVAB targets common neuraminidase enzymes in influenza A and B, but its effectiveness against emerging variants requires ongoing monitoring and potential formulation updates.

5. How might regulatory changes impact RAPIVAB's future?
   Stricter FDA regulations on antivirals could delay expansions, while international approvals might open new markets, balancing potential growth with compliance challenges.

Sources

1. BioCryst Pharmaceuticals. 2023 Annual Report. Available at: BioCryst investor relations website.
2. IQVIA Institute. 2023 Report on Global Antiviral Market Trends. Available at: IQVIA publications.
3. U.S. Food and Drug Administration. RAPIVAB Approval and Labeling Information, 2014 and 2018 updates. Available at: FDA drug database.