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:	1,183
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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2006341592
Australia	2007215156
Australia	2013216632
Australia	2016262644
Brazil	PI0621552
Brazil	PI0707769
Canada	2642260

Last updated: June 7, 2026

Rapivab (IV peramivir) market dynamics and financial trajectory (U.S. and global)

Rapivab (peramivir, IV neuraminidase inhibitor) is a niche, hospital-led antiviral with limited life-cycle breadth in clinical guideline adoption and payer coverage. Its commercial trajectory has shifted from launch growth to post-peak contraction driven by: (1) constrained seasonal demand, (2) competitive substitution by oral oseltamivir and inhaled/intranasal alternatives in practice, (3) competitive pressure from later-seasonal influenza management strategies, and (4) a regulatory footprint concentrated in limited indications and geographies.

What is Rapivab’s commercial role in influenza season and acute-care settings?

Rapivab is used in acute hospital and emergency settings for influenza where IV administration is preferred, particularly when oral therapy is not feasible. Market behavior follows seasonal influenza incidence rather than year-round chronic demand.

Where does demand concentrate?

• Setting: hospitals, EDs, and high-acuity inpatient wards
• Customer: ID clinics, infectious disease specialists, emergency medicine, hospital pharmacy formularies
• Trigger: influenza hospitalization spikes and rapid viral testing workflows

What drives per-season revenue volatility?

• influenza attack rate and hospitalization rate
• guideline alignment with neuraminidase inhibitors
• payer and formulary edits driven by cost and comparative effectiveness
• IV stock management by hospital systems

Which competitors most affect Rapivab pricing, usage, and formulary access?

Rapivab competes primarily in neuraminidase inhibitor space and indirectly in broader antiviral pathways.

Direct substitutes

• Oseltamivir (oral): dominant in outpatient-to-inpatient transitions when oral administration is feasible
• Zanamivir (inhaled) and other localized options: depending on country and patient profile
• Other IV neuraminidase inhibitors (where present): competitive positioning varies by geography and market history

Indirect substitutes

• broader influenza management strategies: rapid diagnosis, early outpatient antiviral access, and reduced reliance on inpatient IV regimens

What do the market dynamics imply for Rapivab’s financial trajectory?

A hospital-niche antiviral typically shows:

• front-loaded adoption when evidence, labeling, and hospital protocols align with launch expectations
• peak-and-decline when formularies standardize to cheaper oral options
• continued but limited volume if an IV “rescue” role persists for specific patient groups

Trajectory pattern for Rapivab

• Launch/early growth phase: initial formulary adoption and acute-care protocol uptake
• Mature decline phase: substitution to oral therapy when feasible and tighter pharmacy governance
• Stabilization as a “last-feasible-oral” product: lower but persistent seasonal usage

How do labeling scope and guideline alignment shape revenue over time?

Rapivab’s revenue is constrained by the size of the eligible patient pool and by the extent to which clinicians treat IV neuraminidase inhibitors as first-line.

Key constraint: eligible population

Revenue exposure correlates with:

• proportion of influenza cases requiring or selecting IV antivirals
• clinician preference for IV therapy when oral is contraindicated
• payer coverage policies for IV antivirals in inpatient and ED protocols

Guideline adoption effects

When major practice pathways prioritize early oral treatment, IV peramivir use declines unless specific clinical scenarios mandate IV access.

What is the FDA regulatory status of Rapivab, and how does it affect U.S. revenues?

Rapivab is an FDA-approved IV peramivir product. Regulatory status shapes U.S. commercial access through labeling eligibility, labeling updates, and manufacturing continuity.

U.S. commercial impact channels

• labeling limits the addressable seasonal patient pool
• manufacturing reliability affects hospital ordering and backup protocols
• post-approval enforcement and supply stability affect seasonal tendering and allocation planning

Does Rapivab face biosimilar or generic substitution pressure?

Rapivab is a small-molecule drug product, not a biologic. Therefore, it faces generic substitution risk rather than biosimilar displacement.

What typically drives generic risk for a small-molecule hospital drug

• expiration of key patents tied to composition, manufacturing, or packaging
• ANDA entry if generics can support bioequivalence and meet labeling requirements
• formulary substitution once generics gain confidence and contract pricing

How strong is Rapivab’s patent estate, and when does exclusivity end matter for revenue?

Small-molecule hospital products often experience accelerated volume loss after:

• key composition or formulation patents expire
• bottlenecks clear for generic manufacturing and FDA approval pathways
• key supply contracts allow switching

Revenue impact of generic entry

• immediate market share erosion through price competition
• replacement by generics in hospital purchasing agreements
• residual brand retention only where contracting or supply risk prevents switching

(No patent-by-patent expiration table is provided here because this analysis must stay specific and complete to named jurisdictions, listing status, and expiration dates.)

What Orange Book status typically determines launch and switching behavior for Rapivab?

In practice, Orange Book listings govern:

• whether FDA-approved generics can file ANDAs against listed patents
• whether Paragraph IV challenges occur
• whether brand companies secure settlements that delay generic entry

Practical market consequences

• patent litigation and settlements determine generic launch timing
• launch timing drives step-function revenue declines, especially in institutional channels

What patent litigation and Paragraph IV challenges have historically mattered for Rapivab?

Paragraph IV litigation affects:

• generic entry dates
• hospital tender cycles and contract negotiations
• brand discounting to defend against impending switching

(No litigation timeline is provided because an accurate report requires verified case identifiers, filing/decision dates, and docket-level outcomes.)

How does Rapivab pricing typically evolve in a hospital-niche antiviral market?

Pricing pressure increases with maturity and competitive substitution, usually manifesting as:

• higher reliance on rebates, contracts, and formulary tier placement
• narrower usage protocols to justify higher acquisition costs
• net price compression versus list price after tender cycles

Net price drivers

• purchasing group contracting in ID and pharmacy networks
• seasonal volume forecasting and inventory management costs
• competitor contract pricing and IV procurement alignment

What are the likely revenue exposure sensitivities for Rapivab?

Rapivab revenue is most sensitive to:

• influenza incidence and severe case share
• hospital formulary tier and protocol adoption
• competitive substitution to cheaper antivirals when feasible
• generic entry timing if exclusivity lapses and ANDA approvals occur

Common financial KPIs for a niche antiviral

• prescription or treatment course volume per season
• average net price per dose or per course (after rebates)
• hospital contract penetration and formulary “pull-through”
• inventory turns and seasonal procurement quantities

How does Rapivab compare with other influenza antivirals on market breadth?

Compared with oral or broader-access antivirals, Rapivab generally has narrower addressability:

• more concentrated inpatient/ED usage
• narrower prescribing triggers (IV need)
• more dependence on hospital pharmacy procurement cycles

Commercial implication

Even with strong acute-care efficacy positioning, market size is limited by route-of-administration constraints and substitution by less expensive oral options.

What is the global market dynamic for peramivir and where are opportunities most likely?

Peramivir’s footprint varies by country based on:

• national guideline adoption
• reimbursement and formulary structure
• availability of alternative antivirals

Global demand patterns

• strongest in markets that support IV neuraminidase inhibitors in inpatient pathways
• weaker where outpatient antiviral access reduces hospitalization demand for IV antivirals

How do manufacturing and supply considerations affect Rapivab’s seasonal revenue?

Hospital antiviral procurement is highly sensitive to:

• uninterrupted supply during peak influenza weeks
• packaging and cold-chain logistics (if applicable)
• manufacturing capacity stability

Any supply interruption can reduce treatment courses and harm formulary confidence.

Key takeaways

• Rapivab operates as a seasonal, hospital-led IV antiviral with revenue tied to influenza incidence and acute-care treatment protocols.
• Commercial trajectory typically follows a launch peak then contraction, driven by substitution toward oral antivirals when administration is feasible and tighter formulary governance.
• Financial performance is most sensitive to formulary tiering, contract pricing, and generic entry timing rather than to long-term chronic utilization growth.
• Market outcomes hinge on regulatory and patent status via Orange Book listings and potential generic switching events.

FAQs

1. What determines hospital uptake of IV peramivir instead of oral oseltamivir?
2. How does generic entry timing for small-molecule neuraminidase inhibitors typically affect brand revenues in the U.S.?
3. What reimbursement structures most influence net pricing for hospital antivirals during influenza season?
4. How do guideline updates shift IV antiviral use toward or away from peramivir?
5. What supply disruptions matter most for seasonal antivirals and how do they impact contracts?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Package / Product Labeling for Rapivab (peramivir). U.S. Food and Drug Administration.
3. NCCN / IDSA / CDC influenza treatment guidance documents (latest versions applicable to neuraminidase inhibitor selection). CDC / IDSA / NCCN.

DrugChatter Q&A for RAPIVAB

How does Rapivab treat the flu?