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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-two 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:	42
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	3
Patent Applications:	1,077
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
Johns Hopkins University	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/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
Eurasian Patent Organization	200870263	ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ ВИРУСНОЙ ИНФЕКЦИИ
Japan	5118502
Japan	2011256196	SUBSTITUTED CYCLOPENTANE AND CYCLOPENTENE COMPOUND USEFUL AS NEURAMINIDASE INHIBITOR
Eurasian Patent Organization	025483	ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ СЕЗОННОГО ГРИППА (INTRAVENOUS METHOD FOR TREATING A SEASONAL INFLUENZA)
Japan	2013256527	INTRAVENOUS ANTIVIRAL TREATMENT
China	104784166	Antiviral compound, dosage form including same, and uses thereof

RAPIVAB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RAPIVAB

Introduction to RAPIVAB

RAPIVAB, also known as peramivir injection, is an antiviral drug developed by BioCryst Pharmaceuticals, Inc. It is designed to treat acute uncomplicated influenza in adults.

Clinical Efficacy and Approval

The efficacy of RAPIVAB is based on clinical trials involving naturally occurring influenza, primarily targeting influenza A infections[1].

Market Demand and Government Contracts

The U.S. Department of Health and Human Services (HHS) has shown significant interest in RAPIVAB for pandemic influenza preparedness. In August 2022, the HHS exercised an option to purchase an additional 10,000 doses of RAPIVAB for approximately $7 million, highlighting the government's commitment to strengthening national preparedness against potential pandemic influenza events[1].

Revenue Contribution

RAPIVAB contributes to BioCryst's revenue, although it is not the company's primary revenue driver. In the fourth quarter of 2023, RAPIVAB-related sales generated $2.3 million in net revenue, down from $8.7 million in the same period of 2022. This decrease was partly due to the completion of the U.S. Department of Health and Human Services procurement contract in 2022[5].

Financial Performance in Recent Quarters

For the third quarter of 2024, BioCryst reported a GAAP operating profit of $7.7 million, a significant improvement from the GAAP operating loss of $11.9 million in the third quarter of 2023. Non-GAAP operating profit, excluding stock-based compensation expense, was $24.9 million for the third quarter of 2024, up from $0.4 million in the third quarter of 2023. While RAPIVAB's contribution to these figures is not isolated, the overall financial health of BioCryst is positively impacted by its antiviral portfolio[2][3].

Full-Year Revenue Guidance

BioCryst has adjusted its full-year 2024 revenue guidance to include additional revenue from RAPIVAB. The company now expects total product revenue for 2024 to be between $443 million and $448 million, with RAPIVAB contributing to this figure alongside the primary driver, ORLADEYO[3].

Operating Expenses and Revenue Outlook

The increased revenue from both ORLADEYO and RAPIVAB has led to a revision in operating expenses for 2024. BioCryst now expects full-year 2024 operating expenses to be between $380 million and $390 million, driven by increased costs of goods sold (COGS) related to new RAPIVAB sales and other variable costs[3].

Global Influenza Treatment Market Context

The global influenza treatment market, in which RAPIVAB operates, was estimated at USD 5.91 billion in 2023 and is expected to grow at a CAGR of 1.18% from 2024 to 2030. While baloxavir marboxil is anticipated to be a key growth driver, peramivir (RAPIVAB) remains a significant player in the market, particularly in the segment of injectable antivirals[4].

Regional Market Dynamics

The Asia Pacific region is expected to show the fastest growth in the influenza treatment market, driven by an increased elderly population, improved healthcare infrastructure, and enhanced influenza surveillance. While RAPIVAB's specific performance in this region is not detailed, the overall market trends suggest potential for growth in antiviral treatments[4].

Distribution and Sales Channels

RAPIVAB is typically distributed through hospital pharmacies, which is a key distribution channel for antiviral drugs. The drug's inclusion in government stockpiling and procurement contracts further underscores its importance in hospital settings[4].

Competitive Landscape

The influenza treatment market is competitive, with other antiviral drugs like oseltamivir phosphate, zanamivir, and baloxavir marboxil. RAPIVAB's unique selling point is its injectable form, which can be particularly useful in certain clinical settings or for patients who cannot take oral medications[4].

Future Outlook

Given the ongoing demand for antiviral treatments and the government's continued interest in pandemic preparedness, RAPIVAB is likely to remain a valuable asset in BioCryst's portfolio. The company's adjusted revenue guidance and the growing influenza treatment market indicate a positive trajectory for RAPIVAB, although its financial impact will be closely tied to the performance of ORLADEYO and overall market conditions.

Key Takeaways

• RAPIVAB is an antiviral drug used to treat influenza, with significant government contracts for pandemic preparedness.
• The drug contributes to BioCryst's revenue, although it is not the primary revenue driver.
• BioCryst has adjusted its full-year 2024 revenue guidance to include additional revenue from RAPIVAB.
• The global influenza treatment market is growing, with the Asia Pacific region showing the fastest growth.
• RAPIVAB's distribution is primarily through hospital pharmacies.

FAQs

What is RAPIVAB used for?

RAPIVAB (peramivir injection) is used to treat acute uncomplicated influenza in adults.

Who is the primary buyer of RAPIVAB?

The U.S. Department of Health and Human Services (HHS) has been a significant buyer of RAPIVAB for pandemic influenza preparedness.

How much revenue did RAPIVAB generate in the fourth quarter of 2023?

In the fourth quarter of 2023, RAPIVAB-related sales generated $2.3 million in net revenue.

What is the expected growth rate of the global influenza treatment market?

The global influenza treatment market is expected to grow at a CAGR of 1.18% from 2024 to 2030.

Through which channels is RAPIVAB typically distributed?

RAPIVAB is typically distributed through hospital pharmacies.

Sources

1. U.S. Government Exercises Option to Purchase Additional RAPIVAB® (peramivir injection) from BioCryst for Pandemic Influenza Preparedness - BioCryst Pharmaceuticals, Inc.
2. BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update - BioCryst Pharmaceuticals, Inc.
3. BioCryst Reports Third Quarter 2024 Financial Results and Provides Business Update - BioSpace
4. Influenza Treatment Market Size And Share Report, 2030 - Grand View Research
5. BioCryst Reports Fourth Quarter and Full Year 2023 Financial Results - BioCryst Pharmaceuticals, Inc.